Appendix 6 Calificacion de Sisitemas y Equipos

Appendix 6
Qualification of systems and equipment

1. Principle
2. Scope
3. General
4. Design qualification
5. Installation qualification
6. Operational qualification
7. Performance qualification
8. Requalification
9. Qualification of in use systems and equipment
1. Principle
1.1 Systems and equipment should be appropriately designed, located,

installed, operated and maintained to suit their intended purpose.
1.2 Critical systems, i.e. those whose consistent performance may have
an impact on the quality of products, should be qualified. These may include,
where appropriate, water purification systems, air-handling systems,
compressed air systems and steam systems.
1.3 The continued suitable performance of equipment is important to
ensure batch-to-batch consistency. Critical equipment should therefore be
qualifi ed.
2. Scope
2.1 These guidelines describe the general aspects of qualification for

systems and equipment.
2.2 Normally qualification would be applicable to critical systems and
equipment whose performance may have an impact on the quality of the
product.
3. General
3.1 The manufacturer should have a qualification policy for systems and
equipment.
3.2 Equipment (including instruments) used in production and quality
control should be included in the qualification policy and programme.
3.3 New systems and equipment should pass through all stages of qualifi
cation including design qualifi cation (DQ), installation qualifi cation (IQ),
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operational qualifi cation (OQ) and performance qualifi cation (PQ) as

appropriate
(Fig. 1).
3.4 In some cases, not all stages of qualifi cation may be required. See also
the guidelines on the qualifi cation of water purifi cation systems in Appendix
2 and heating, ventilation and air-conditioning (HVAC) in Appendix 1.
3.5 Systems should be qualifi ed before equipment.
3.6 Equipment should be qualifi ed prior to being brought into routine
use to provide documented evidence that the equipment is fi t for its intended
purpose.
3.7 Systems and equipment should undergo periodic requalifi cation, as
well as requalifi cation after change.
3.8 Certain stages of the equipment qualifi cation may be done by the
supplier or a third party.
3.9 The relevant documentation associated with qualifi cation including
standard operating procedures (SOPs), specifi cations and acceptance criteria,
certifi cates and manuals should be maintained.
3.10 Qualifi cation should be done in accordance with predetermined and
approved qualifi cation protocols. The results of the qualifi cation should be
recorded and refl ected in qualifi cation reports.
3.11 The extent of the qualifi cation should be based on the criticality of a
system or equipment (e.g. blenders, autoclaves or computerized systems).
Figure 1
Stages of qualifi cation
Design qualification
Installation qualification
Operational qualification
Performance qualification
Change control
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4. Design
qualifi cation
Note: see also Supplementary guidelines on good manufacturing practices

(GMP): validation.
4.1 User requirements should be considered when deciding on the specifi
c design of a system or equipment.
4.2 A suitable supplier should be selected for the appropriate system or
equipment (approved vendor).
5. Installation
qualifi cation

(GMP): validation.
5.1 Systems and equipment should be correctly installed in accordance
with an installation plan and installation qualifi cation protocol.
5.2 Requirements for calibration, maintenance and cleaning should be
drawn up during installation.
5.3 Installation qualifi cation should include identifi cation and verifi cation
of all system elements, parts, services, controls, gauges and other
components.
5.4 Measuring, control and indicating devices should be calibrated
against appropriate national or international standards, which are traceable.
5.5 There should be documented records for the installation (installation
qualifi cation report) to indicate the satisfactoriness of the installation,
which should include the details of the supplier and manufacturer, system
or equipment name, model and serial number, date of installation, spare
parts, relevant procedures and certifi cates.
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Format for an installation qualifi cation protocol and report a
Validation protocol _________ Installation Qualifi cation _________ Page _____ of _____
Title: ______________ Name and address of site: ________________________________
________________________________________________________________________________
Validation Protocol # __________________________________ IQ Protocol number: ______
Title: ___________________________________________________________________________
Protocol written by: _________________________________
Protocol approved by: ______________________________ Date: _____________________
QA Approval: ______________________________________ Date: _____________________
Objective
To ensure that _________________ (system/equipment) installed conforms to the purchase
specifi cations and the manufacturer details and literature, and to document the
information that ________________________ (system/equipment) meets its specifi cations.
Equipment inventory number: _____________________________________________________
Scope
To perform installation qualifi cation as described in this IQ protocol at the time of
installation, modifi cation and relocation.
Responsibility
___________________ (post/person) overseeing the installation will perform the qualifi cation
and records results.
___________________ (post/person) will verify results and write the report.
Quality Assurance will review and approve the IQ protocol and report.
This format is used for training purposes and refl ects some of the possible contents for an installation qualifi cation
protocol.
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Format for an installation qualifi cation protocol and report (continued) a
________________________________________________________________________________
System/Equipment _______________________________ Code no.: ___________________
a. Description of the system/equipment being installed: general description of the function
and the main components.
_______________________________________________________________________________
_______________________________________________________________________________
_______________
b. List of the main components:
1. _________________________________ Code no.: _____________________________
2. _________________________________ Code no.: _____________________________
3. _________________________________ Code no.: _____________________________
4. _________________________________ Code no.: _____________________________
c. Description of supporting utilities (e.g. piping, connections, water supply)
1. _________________________________ Code no.: _____________________________
2. _________________________________ Code no.: _____________________________
3. _________________________________ Code no.: _____________________________
4. _________________________________ Code no.: _____________________________
Procedure
1. Prepare a checklist of all components and parts, including spare parts according to
the purchase order and manufacturers specifi cations.
2. Record the information for each actual part, component, item of auxiliary equipment,
supporting facilities, and compare with the manufacturers specifi cations.
3. Record any deviations to the system/equipment.
4. Prepare a deviation report including justifi cation of acceptance and impact on the
function.
5. Prepare an IQ report.b
6. Submit the report to QA for review and approval.
protocol.
a As a minimum, the IQ report should include the date of initiation of the study, date completed, observations
made, problems encountered, completeness of information collected, summary of deviation report, results of
any tests, sample data (if appropriate), location of original data, other information relevant to the study, and the
conclusion on the validity of the installation.
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________________________________________________________________________________
Checklist for component no. ______________________
Name: _________________________________________ Code no.: ____________________
Component function: ____________________________________________________________
Require/order Actual Deviations
1 Model/serial no.
2 Specifi cation
3 Manual
4 Drawing
5 Wiring/cabling
6 Power, fusing
7 SOP (operation)
SOP (maintenance)
SOP (calibration)
8 Input/output control
9 Environment
10 Test equipment or instruments
11 Utilities and service
12 Spare parts list, part number
and supplier
13 Other
Performed by: _________________________________ Date: _______________________
Deviations: _____________________________________ Date: _______________________
Verifi ed by: _____________________________________ Date: _______________________
protocol.
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________________________________________________________________________________
Deviation report
Deviations: _____________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
__________________________________________________________________________________________________
__________________________________________________________________________________________________
_________________________________________________________________________________________________
_________________________________________________________________________________________________
Justifi cation for acceptance
________________________________________________________________________________
________________________________________________________________________________
_______________________________________________________________________________________________________
___________
_______________________________________________________________________________________________________
___________
_______________________________________________________________________________________________________
___________
_______________________________________________________________________________________________________
___________
_______________________________________________________________________________________________________
___________
_______________________________________________________________________________________________________
___________
Impact on operation:
________________________________________________________________________________
________________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
Report written by: _______________________________ Date: _______________________
protocol.
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________________________________________________________________________________
Installation qualifi cation report
Results: _______________________________________________________________________
________________________________________________________________________________
_______________________________________________________________________________________________________
__________________
_______________________________________________________________________________________________________
__________________
_______________________________________________________________________________________________________
__________________
Conclusions:
________________________________________________________________________________
________________________________________________________________________________
_______________________________________________________________________________________________________
___________________
_______________________________________________________________________________________________________
___________________
_______________________________________________________________________________________________________
___________________
________________________________________________________________________________
________________________________________________________________________________
_______________________________________________________________________________________________________
_____
_______________________________________________________________________________________________________
____
Report written by: _______________________________ Date: _______________________
QA approved by: _______________________________ Date: _______________________
This format is used for training purposes and refl ects some of the possible contents for an installation qualifi cation protocol.
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6. Operational
qualifi cation

(GMP): validation.
6.1 Systems and equipment should operate correctly and their operation
should be verifi ed in accordance with an operational qualifi cation protocol.
6.2 Critical operating parameters should be identifi ed. Studies on the critical
variables should include conditions encompassing upper and lower operating
limits and circumstances (also referred to as worst case conditions).
6.3 Operational qualifi cation should include verifi cation of operation of
all system elements, parts, services, controls, gauges and other components.
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6.4 There should be documented records for the verifi cation of operation
(operational qualifi cation report) to indicate the satisfactory operation.
6.5 Standard operating procedures for the operation should be fi nalized
and approved.
6.6 Training of operators for the systems and equipment should be provided,
and training records maintained.
6.7 Systems and equipment should be released for routine use after
completion of operational qualifi cation, provided that all calibration, cleaning,
maintenance, training and related tests and results were found to be
acceptable.
Format for an operational qualifi cation protocola
Validation protocol _________ Operational Qualifi cation ________ Page _____ of _____
Title: ______________ Name of Facility: _________________________________________
________________________________________________________________________________
Validation Protocol # ____________________ Operational Qualifi cation _______________
Title ____________________________________________________________________________
________________________________________________________________________________
Protocol written by _______________________________________________________________
Departmental Approval by ____________________________________ Date ____________
QA Approval by ______________________________________________ Date ____________
Objective
To determine that the system/equipment operates according to specifi cations, and to
record all relevant information and data to demonstrate that the system/equipment functions
as expected.
Scope
To be performed after installation, modifi cation or relocation, after the Installation Qualifi cation has been completed.
Responsibility
Person responsible for operating the system/equipment will perform the qualifi cation and
record the information.
The supervisor will supervise the study, verify the completion of the records, write the
deviation report and the Operational Qualifi cation (OQ) Report.
Qualify Assurance will review and approve the OQ protocol and report.
This format is used for training purposes and refl ects some of the possible contents for an operational qualifi cation protocol.
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Format for an operational qualifi cation protocol (continued) a
________________________________________________________________________________
Materials, Equipment, Documents
List of calibration equipment required (Chart 1).
Materials or supplies needed to perform the Operational Qualifi cation
1 ____________________________________________________________ Code # __________
2 ____________________________________________________________ Code # __________
3 ____________________________________________________________ Code # __________
4 ____________________________________________________________ Code # __________
5 ____________________________________________________________ Code # __________
6 ____________________________________________________________ Code # __________
SOPs and datasheets for normal operations of the system under test (Chart 2).
Training records documenting that operators have been trained (Chart 2).
Manuals for equipment (Chart 2).
Procedure
Test and record calibration data for calibrating apparatus and instruments (Chart 1).
Test and record operative condition of control points and alarms (Chart 3).
Test and record outputs (Chart 4).
List of calibration requirements for the system under test and records of the calibration of
the system (Chart 5).
Measure and record the results of specifi c challenge to the system in normal and worst
case situation where appropriate (Chart 6).
Record any deviations to the procedures performed.
Prepare a Deviation Report including the justifi cation of acceptance and impact on the
operation.
Prepare an Operational Qualifi cation Report. This should include date study initiated;
date completed; observations made; problems encountered; completeness of information
collected; summary of deviation report; results of control/alarm tests; sample data if
appropriate; location of original data; other information relevant to the study; and conclusions
on the validity of the equipment/system operations.
Submit QA for review and approval.
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________________________________________________________________________________
Preparation
Chart 1: Calibrating apparatus and instruments.
Apparatus/Instrument Calibration method Calibration date
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________

_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
Performed by: _____________________________________________ Date ____________
Deviations: ____________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
Verifi ed by: ________________________________________________ Date ____________
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________________________________________________________________________________
Preparation
Chart 2: Document check
SOP Title and number File location QA/QC approval date
____________________ ___________________________ _______________________
____________________ ___________________________ _______________________
____________________ ___________________________ _______________________
____________________ ___________________________ _______________________
____________________ ___________________________ _______________________
Training Records
Course on SOP # Staff name Date
______________ _________________________________________ ______________
______________ _________________________________________ ______________
______________ _________________________________________ ______________
______________ _________________________________________ ______________
______________ _________________________________________ ______________
Equipment Make and Model Manual Available
______________________________________________________________ Y [ ] N [ ]
______________________________________________________________ Y [ ] N [ ]
______________________________________________________________ Y [ ] N [ ]
Deviations: ____________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
Verifi ed by: ________________________________________________ Date ____________
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________________________________________________________________________________
Results
Chart 3: Control points and alarms.
Control point/Alarm Results Date
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________

Deviations: ____________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
Verifi ed by: ________________________________________________ Date ____________
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________________________________________________________________________________
Results
Chart 4: Outputs
Outputs Results Date
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
Deviations: ____________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
Verifi ed by: ________________________________________________ Date ____________
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________________________________________________________________________________
Chart 5: Calibration of Equipment/System
Calibration SOP Result Date
(short title and #)
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________

_____________________ ______________________________________ _______________
Deviations: ____________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
Verifi ed by: ________________________________________________ Date ____________
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________________________________________________________________________________
Chart 6: Specifi c challenge of the equipment or system
Test in normal conditions:
Test of worst case situation:
(e.g. start-up after shutdown, temperature recovery time, centrifuge imbalance)
Deviations: ____________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
Verifi ed by: ________________________________________________ Date ____________
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________________________________________________________________________________
Deviation Report
Deviation(s):
Justifi cation for acceptance:
Impact on operation:
Written by: ________________________________________________ Date ____________
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________________________________________________________________________________
Operational Qualifi cation Report
Results:
Conclusions:
Written by: _________________________________________________ Date ____________
QA approved by: ____________________________________________ Date ____________
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7. Performance
qualifi cation

(GMP): validation.
7.1 Systems and equipment should consistently perform in accordance with
design specifi cations. The performance should be verifi ed in accordance
with a performance qualifi cation protocol.
7.2 There should be documented records for the verifi cation of performance
(performance qualifi cation report) to indicate the satisfactory performance
over a period of time. Manufacturers should justify the selected
period over which performance qualifi cation is done.
Format for a performance qualifi cation protocol a
Validation protocol _________ Performance Qualifi cation _________ Page _____ of _____
Title: ______________________ Name of facility: ____________________________________
_________________________________________________________________________________
Validation Protocol # _______________________ Performance Qualifi cation
Title ____________________________________________________________________________
________________________________________________________________________________
Protocol written by _______________________________________________________________
Departmental Approval by ____________________________________ Date ____________
QA Approval by ______________________________________________ Date ____________
Objective
To determine that the systems/equipment perform as intended by repeatedly running the
system on its intended schedules and recording all relevant information and data. Results
must demonstrate that performance consistently meets pre-determined specifi cations
under normal conditions, and where appropriate for worst case situations.
Scope
To be performed after the Installation and Operational Qualifi cation have been completed
and approved.
To be performed after installation, modifi cation or relocation and for re-validation at
appropriate intervals.
Each piece of equipment must be validated before it serves another piece of equipment/
system during validation of the latter (e.g. water system before steam generator; steam
generator before autoclave).
This format is used for training purposes and refl ects some of the possible contents for a performance qualifi cation protocol.
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Format for a performance qualifi cation protocol (continued) a
_________________________________________________________________________________
Responsibility
Person responsible for operating the system or equipment will perform the qualifi cation
and record the information.
The supervisor will supervise the study, verify the completion of the records and write the
Deviation Report and the Performance Qualifi cation Report.
Qualify Assurance will review and approve the Performance Qualifi cation Protocol and
Report.
Materials, Equipment, Documents
SOPs for normal operations of the equipment or system under test (including data record
forms, charts, diagrams materials and equipment needed). Attach copies.
SOP list:
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
SOPs specifi c for performance tests (including data record forms, charts, diagrams, materials
and equipment needed, calculations and statistical analyses to be performed, and
pre-determined specifi cations and acceptance criteria). Attach copies.
SOP list:
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
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_________________________________________________________________________________
Procedure
Equipment: Run normal procedure three times for each use (confi guration or load) and
record all required data and any deviations to the procedure.
Systems: Run for 20 consecutive working days, recording all required data and any
deviations to the procedure.
Prepare the Summary Data Record Form(Chart 1).

Evaluation
Attach all completed, signed data record forms.
Complete the Summary Data Record Form (Chart 1).
Perform all required calculations and statistical analyses (Chart 2).
Compare to acceptance criteria (Chart 3).
Prepare Deviation Report including the justifi cation of acceptance and impact on the
performance.
Prepare a Performance Qualifi cation Report: This should include: date study initiated;
date completed; observations made; problems encountered; completeness of information
collected; summary of deviation report; results of any tests; do results meet acceptance
criteria; location of original data; other information relevant to the study; and conclusions
on the validity of the equipment/system.
Submit Performance Qualifi cation Document to QA for review and approval.
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_________________________________________________________________________________
Chart 1: Summary Data Record
(To be prepared for the specifi c procedure being tested)
Verifi ed by: ________________________________________________ Date ____________
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_________________________________________________________________________________
Chart 2: Calculations and Statistical Analyses
Verifi ed by: ________________________________________________ Date ____________
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_________________________________________________________________________________
Chart 3: Acceptance Criteria vs. Performance Test Results
Criteria Results Pass/Fail
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________

__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
Verifi ed by: ________________________________________________ Date ____________
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_________________________________________________________________________________
Deviation Report
Deviation(s):
Justifi cation for acceptance:
Impact on operation, function or process:
Written by: _____________________________________________ Date ____________
Verifi ed by: ________________________________________________ Date ____________
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_________________________________________________________________________________
Performance Qualifi cation Report
Results:
Conclusions:
Written: _____________________________________________ Date ____________
Verifi ed by: ________________________________________________ Date ____________
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8. Requalifi
cation

(GMP): validation.
8.1 Requalifi cation of systems and equipment should be done in accordance
with a defi ned schedule. The frequency of requalifi cation may be
determined on the basis of factors such as the analysis of results relating to
calibration, verifi cation and maintenance.
8.2 There should be periodic requalifi cation.
8.3 There should be requalifi cation after changes. The extent of requalifi
cation after the change should be justifi ed based on a risk-assessment of
the change. Requalifi cation after change should be considered as part of the
change control procedure.
9. Qualifi
cation of in-use systems and equipment
9.1 There should be data to support and verify the suitable operation and
performance of systems and equipment that have been in use for a period
of time, and which had not been subjected to installation and or operational
qualifi cation.
9.2 These should include operating parameters and limits for critical
variables, calibration, maintenance and preventive maintenance, standard
operating procedures (SOPs) and records.
10. Reference
A WHO guide to good manufacturing practice (GMP) requirements.

Part 2: Validation. Geneva, Global Programme for Vaccines and Immunization,
Vaccine Supply and Quality, Global Training Network, World
Health Organization, 1997 (WHO/VSQ/97.02).
Apndice 6
Calificacin de equipos y sistemas
1. principio
2. mbito de aplicacin
3. general
4. diseo de calificacin
5. calificacin de instalacin
6. operacional calificacin
7. calificacin de desempeo
8. recalificacin
9. calificacin de "en uso" sistemas y equipos
1. principio
1.1 sistemas y equipos deben ser adecuadamente diseados, ubicado,

instalado, operado y mantenido para satisfacer su aplicacin prevista.
1.2 sistemas crticos de, es decir, aquellos cuyo desempeo consistente puede
tener
un impacto en la calidad de los productos, debe ser calificado. Estos pueden
incluir,
en su caso, sistemas de purificacin de agua, sistemas de aire acondicionado,
sistemas de aire comprimido y sistemas de vapor.
1.3 el adecuado funcionamiento continuo del equipo es importante
asegurar la consistencia de lote a lote. Equipos crticos por lo tanto deben ser
califi cado.
2. alcance
2.1 estas pautas describen los aspectos generales de calificacin para

sistemas y equipos.
2.2 normalmente calificacin sera aplicable a los sistemas crticos y
equipos cuyo funcionamiento pueden tener un impacto en la calidad de la
producto.
3. general
3.1. el fabricante debe tener una poltica de calificacin para sistemas y

equipo.
3.2 equipo (incluyendo instrumentos) utilizado en la produccin y calidad
control se debe incluir en el programa y la poltica de calificacin.
3.3 nuevos sistemas y equipos deben pasar por todas las etapas de califi
cacin incluyendo diseo cualifi cacin (DQ), cacin de califi cada de
instalacin (IQ),
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148
cacin de califi operacional (OQ) y cacin de califi rendimiento (PQ) como

adecuadas
(Fig. 1).
3.4 en algunos casos, no todas las etapas de califi cacin pueden ser
necesarias. Vase tambin
las directrices sobre la califi cacin purifi cacin de sistemas de agua en el

Apndice
2 y de la calefaccin, ventilacin y aire acondicionado (HVAC) en el apndice 1.
3.5 los sistemas deben ser califi cado antes el equipo.
3.6 equipo debe ser califi cado antes de ser trado en rutina
uso para proporcionar evidencia documentada que el equipo es fi n para su
destino
propsito.
3.7 sistemas y equipos deben someterse a peridicos requalifi cacin, como
bien como catin de requalifi despus del cambio.
3.8 algunas etapas de la cacin de califi cada equipo pueden hacerse por el
proveedor o una tercera persona.
3.9 la documentacin pertinente asociada con califi cacin como
procedimientos operativos estndar (SOPs), especificaciones y criterios de
aceptacin,
Manuales y certifi cados se deben mantener.
3.10 califi cacin debe realizarse de acuerdo con predeterminadas y
aprueba protocolos de califi cacin. Los resultados de la califi cacin deben ser
informes refl ejada en la califi cacin y grabado.
3.11 el alcance de la califi cacin debe basarse en la importancia de una
sistema o equipo (por ejemplo mezcladores, autoclaves o sistemas
informatizados).
Figura 1
Etapas de la califi cacin
Calificacin de diseo
Calificacin de instalacin
Calificacin operacional
Calificacin de desempeo
Control de cambios
149
4. califi
cacin de diseo
Nota: vase tambin "directrices complementarias sobre buenas prcticas de

manufactura
(GMP): validacin ".
4.1 requisitos usuario deben considerarse al decidir el especifi
c diseo de un sistema o equipo.
4.2 un proveedor adecuado se debe seleccionar para el sistema apropiado o
equipo (proveedor homologado).
5. califi
cacin de instalacin

manufactura
(GMP): validacin ".
5.1 sistemas y equipos deben instalarse correctamente de acuerdo
con un plan de instalacin y el protocolo de instalacin califi cacin.
5.2 requisitos para la calibracin, mantenimiento y limpieza deben ser
elaborado durante la instalacin.
5.3 califi cacin de instalacin debe incluir la identifi cacin y verifi cacin
de todos los elementos de sistema, partes, servicios, controles, calibradores y
otros componentes.
5.4 medicin, control y que indica los dispositivos deben ser calibrados
contra normas nacionales o internacionales apropiadas, que son trazables.
5.5 debe existir registros documentados para la instalacin (instalacin

Informe de califi cacin) para indicar que los satisfactores de la instalacin,
que debe incluir la informacin del proveedor y del fabricante, sistema
o nombre del equipo, nmero de modelo y serie, fecha de instalacin, repuesto
partes, los procedimientos relevantes y certifi cados.
150
Formato para un protocolo de instalacin cualifi cacin y un informe
un
Protocolo de validacin _________ Instalacin de califi cacin _________ Pgina _____ de _____
Ttulo: ______________ Nombre y direccin del sitio: ________________________________
________________________________________________________________________________
Protocolo de validacin # ___ nmero de protocolo IQ: ___
Title: ___________________________________________________________________________
Protocolo escrito por: ___
Protocolo aprobado por: ___ Fecha: ___
QA Approval: ______________________________________ Date: _____________________
Objetivo
Para asegurarse de ___ (sistema/equipo) instalado cumple con la compra
especfi cos cationes y el fabricante los datos y la literatura y al documento de la
informacin que ___ (sistema/equipo) cumple con sus especificaciones.
Nmero de inventario de equipo: ___
mbito de aplicacin
Cacin de califi cada de instalacin como se describe en este protocolo de IQ en el momento de
realizar
instalacin, modificacin y reubicacin.
Responsabilidad
___ (puesto/persona) supervisin de la instalacin llevar a cabo la califi cacin
y registra los resultados.
___ (puesto/persona) verificar los resultados y escribir el informe.
Aseguramiento de la calidad ser revisar y aprobar el protocolo de IQ y el informe.
Este formato se utiliza para adiestramiento y refl ects algunos de los posibles contenidos de una cacin de califi
instalacin
Protocolo.
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151
Formato para un protocolo de instalacin califi cacin e informe (continuada)
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________________________________________________________________________________
Equipo de sistema _______________________________ Cdigo no.: ___________________
a. Descripcin del sistema/equipo instalando: Descripcin general de la funcin
y los componentes principales.
_______________________________________________________________________________
_______________________________________________________________________________
_______________
b. lista de los principales componentes:
1. _________________________________ Code no.: _____________________________
2. _________________________________ Code no.: _____________________________
3. _________________________________ Code no.: _____________________________
4. _________________________________ Code no.: _____________________________
c. Descripcin de apoyo a servicios pblicos (p. ej. tuberas, conexiones, suministro de agua)
1. _________________________________ Code no.: _____________________________
2. _________________________________ Code no.: _____________________________
3. _________________________________ Code no.: _____________________________
4. _________________________________ Code no.: _____________________________
Procedimiento
1. prepare una lista de todos los componentes y piezas, incluyendo piezas de repuesto segn
la orden de compra y especificaciones del fabricante.
2. Registre la informacin para cada parte real, componente, equipo auxiliar,
instalaciones y comparar con especifi caciones del fabricante.
3. registrar cualquier desviacin en el sistema/equipo.
4. preparar un informe de desviacin como justifi cacin de la aceptacin y el impacto en la
funcin.
5. preparar un informe de IQ. b
6. presentar el informe de control de calidad para revisin y aprobacin.

instalacin
Protocolo.
un
Como mnimo, el informe de IQ debe incluir la fecha de iniciacin del estudio, fecha completa, observaciones
hechos, problemas, integridad de la informacin recogida, Resumen del informe de desviacin, resultados de
datos de muestra (si procede), ubicacin de datos originales, cualquier prueba, otra informacin relevante para el estudio y
la
conclusin sobre la validez de la instalacin.
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152
un
________________________________________________________________________________
Lista de verificacin para el componente no. ______________________
Name: _________________________________________ Code no.: ____________________
Funcin de componente: ___
Requieren u orden real de las desviaciones
Modelo/1 serie no.
2 especifi cacin
Manual 3
Dibujo 4
5 cables/cableado
Potencia 6, fusin
7 SOP (operacin)
SOP (mantenimiento)
SOP (calibracin)
8 control de entrada/salida
Medio ambiente 9
10 equipo de prueba o instrumentos
11 utilidades y servicio
Lista de 12 piezas de repuesto, nmero de parte
y el proveedor
13 otro
Realizado por: _________________________________ Fecha: _______________________
Desviaciones: _____________________________________ Fecha: _______________________
Verifi cado por: _____________________________________ Fecha: _______________________
instalacin
Protocolo.
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________________________________________________________________________________
Informe de desviacin
Deviations: _____________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
__________________________________________________________________________________________________
__________________________________________________________________________________________________
_________________________________________________________________________________________________
_________________________________________________________________________________________________
Justifi cacin para la aceptacin
________________________________________________________________________________
________________________________________________________________________________
_______________________________________________________________________________________________________
___________
_______________________________________________________________________________________________________
___________
_______________________________________________________________________________________________________
___________
_______________________________________________________________________________________________________
___________
_______________________________________________________________________________________________________
___________
_______________________________________________________________________________________________________
___________
Impacto en la operacin:
________________________________________________________________________________
________________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
Informe escrito por: _______________________________ Fecha: _______________________
instalacin
Protocolo.
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un
________________________________________________________________________________
Informe de instalacin califi cacin
Results: _______________________________________________________________________
________________________________________________________________________________
_______________________________________________________________________________________________________
__________________
_______________________________________________________________________________________________________
__________________
_______________________________________________________________________________________________________
__________________
CONCLUSIONES:
________________________________________________________________________________
________________________________________________________________________________
_______________________________________________________________________________________________________
___________________
_______________________________________________________________________________________________________
___________________
_______________________________________________________________________________________________________
___________________
________________________________________________________________________________
________________________________________________________________________________
_______________________________________________________________________________________________________
_____
_______________________________________________________________________________________________________
____
Informe escrito por: _______________________________ Fecha: _______________________
Control de calidad aprobado por: _______________________________ Fecha: _______________________
Este formato se utiliza para adiestramiento y refl ects algunos de los contenidos posibles para una instalacin califi Protocolo de catin.
un
6. operacional
de califi cacin

manufactura
(GMP): validacin ".
6.1 sistemas y equipos deben funcionar correctamente y su funcionamiento
debe ser verifi cado conforme a un protocolo de funcionamiento califi cacin.
6.2 crticos parmetros de funcionamiento debe ser identifi ed. estudios sobre
la crtica
las variables deben incluir condiciones que abarca funcionamiento superior e

inferior
lmites y circunstancias (tambin contempladas como "peores condiciones").
6.3 funcionamiento califi cacin debe incluir verifi cacin de la operacin de
todos los elementos de sistema, partes, servicios, controles, calibradores y
otros componentes.
155
6.4 debe haber registros documentados para la verifi cacin de funcionamiento

(informe de cacin califi operacional) para indicar la operacin satisfactoria.
6.5 procedimientos de operacin para la operacin debe ser fi nalized
y aprobado.
6.6 capacitacin de operadores de los sistemas y equipos se debe
proporcionar,
y mantenidos los registros de capacitacin.
6.7 sistemas y equipos deben ser lanzados para uso rutinario despus de
realizacin de operativos califi cacin, siempre que toda calibracin, limpieza,
mantenimiento, formacin y relacionados con las pruebas y los resultados
fueron encontrados para ser
Aceptable.
Formato para un protocolo de funcionamiento califi cacin
un
Protocolo de validacin _________ Operacional de la califi cacin ________ Pgina _____ de _____
Ttulo: ______________ Nombre del centro: _________________________________________
________________________________________________________________________________
Protocolo de validacin # ___ operacional califi cacin ___
Title ____________________________________________________________________________
________________________________________________________________________________
Protocolo escrito por ___
Departamental aprobacin de fecha ___ de ___
Aprobacin de control de calidad de ___ de fecha ___
Objetivo
Para determinar que el equipo de sistema opera segn especifi caciones y a
registrar toda la informacin relevante y datos para demostrar que las funciones del sistema y equipos
como era de esperar.
mbito de aplicacin
A realizar despus de la instalacin, modifi cacin o traslado, despus de la instalacin de calificacin se ha completado.
Responsabilidad
Persona responsable de operar el sistema/equipo realizar la califi cacin y
Registre la informacin.
El supervisor ser supervisar el estudio, verificar la realizacin de los registros, escriba el
Informe de desviacin y la cacin califi operacional (OQ) informe.
Calificar garanta revisar y aprobar el protocolo OQ e informe.
Este formato se utiliza para adiestramiento y refl ects algunos de los contenidos posibles para un funcionamiento califi Protocolo de catin.
un
156
Formato para un protocolo de funcionamiento califi cacin (continuado)
un
________________________________________________________________________________
Materiales, equipos, documentos
Lista de equipo de calibracin requerido (tabla 1).
Materiales o suministros necesitan para realizar la operativa califi cacin
1 ____________________________________________________________ Code # __________
2 ____________________________________________________________ Code # __________
3 ____________________________________________________________ Code # __________
4 ____________________________________________________________ Code # __________
5 ____________________________________________________________ Code # __________
6 ____________________________________________________________ Code # __________
SOP y fichas para las operaciones normales del sistema bajo prueba (grfico 2).
Formacin los registros que documentan que los operadores han sido entrenados (grfico 2).
Manuales de equipo (tabla 2).
Procedimiento
Prueba y registro de datos de calibracin para la calibracin de aparatos e instrumentos (tabla 1).
Condicin operativa prueba y registro de puntos de control y alarmas (grfico 3).
Prueba y registro salidas (tabla 4).
Lista de requisitos de calibracin para el sistema bajo prueba y los registros de la calibracin de
el sistema (grfico 5).
Medir y registrar los resultados del desafo c especfi ca al sistema en condiciones normales y lo peor
situacin del caso en su caso (cuadro 6).
Registre cualquier desviacin a los procedimientos realizados.
Preparar un informe de desviacin como la justifi cacin de la aceptacin y el impacto en la
operacin.
Preparar un operativo califi cacin informe. Esto debe incluir el estudio de fecha iniciado;
fecha de finalizacin; observaciones; problemas encontrados; integridad de la informacin
recogidos; Resumen del informe de desviacin; resultados de las pruebas de control de la
alarma; datos de la muestra si
apropiado; Ubicacin de los datos originales; otra informacin relevante para el estudio; y las
conclusiones
sobre la validez de las operaciones del equipo/sistema.
Presentar control de calidad para revisin y aprobacin.
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________________________________________________________________________________
Preparacin
Grfico 1: Calibracin de aparatos e instrumentos.
Fecha de calibracin de mtodo de calibracin del aparato/instrumento
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
Realizado por: _____________________________________________ Fecha ____________
Desviaciones: ____________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
Verifi cado por: ________________________________________________ Fecha ____________
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________________________________________________________________________________
Preparacin
Grfico 2: Verificacin de documento

Ttulo de concesin y fecha de aprobacin de QA/QC de ubicacin nmero de archivo
____________________ ___________________________ _______________________
____________________ ___________________________ _______________________
____________________ ___________________________ _______________________
____________________ ___________________________ _______________________
____________________ ___________________________ _______________________
Registros de capacitacin
Curso sobre SOP # personal nombre fecha
______________ _________________________________________ ______________
______________ _________________________________________ ______________
______________ _________________________________________ ______________
______________ _________________________________________ ______________
______________ _________________________________________ ______________
Equipos de marca y modelo Manual disponible
______________________________________________________________ Y [ ] N [ ]
______________________________________________________________ Y [ ] N [ ]
______________________________________________________________ Y [ ] N [ ]
Desviaciones: ____________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
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________________________________________________________________________________
Resultados
Grfico 3: Puntos de Control y alarmas.
Punto de control/alarma fecha resultados
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
Desviaciones: ____________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
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un
________________________________________________________________________________
Resultados
Tabla 4: resultados
Salidas resultados fecha
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
Desviaciones: ____________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
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________________________________________________________________________________
Cuadro 5: Calibracin del equipo/sistema
Fecha de resultado de la compensacin de calibracin
(ttulo corto y #)
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
Desviaciones: ____________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
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________________________________________________________________________________
Tabla 6: Especifi c reto del equipo o sistema
La prueba en condiciones normales:
Prueba de la situacin caso peor:
(por ejemplo, puesta en marcha despus de apagado, tiempo de recuperacin de la temperatura,
desequilibrio de centrfuga)
Desviaciones: ____________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
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un
________________________________________________________________________________
Deviation(s):
Justifi cacin para la aceptacin:
Impacto en la operacin:
Escrito por: ________________________________________________ Fecha ____________
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36V
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________________________________________________________________________________
Operacional califi cacin informe
Resultados:
CONCLUSIONES:
Escrito por: _________________________________________________ Fecha ____________
Control de calidad aprobado por: ____________________________________________ Fecha ____________
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165
7. califi
cacin de funcionamiento

manufactura
(GMP): validacin ".
7.1 sistemas y equipos deben realizar constantemente de acuerdo con
especifi caciones de diseo. El rendimiento debe ser verifi cado de acuerdo
con protocolo actuacin califi cacin.
7.2 debe existir registros documentados para la verifi cacin del
funcionamiento
(califi cacin Informe sobre el rendimiento) para indicar el desempeo
satisfactorio
durante un perodo de tiempo. Fabricante debe justificar los seleccionados
perodo en que desempeo califi cacin se realiza.
Formato para un protocolo de actuacin califi cacin
un
Protocolo de validacin _________ Rendimiento de califi cacin _________ Pgina _____ de _____
Ttulo: ______________________ Nombre del centro: ____________________________________

_________________________________________________________________________________
Protocolo de validacin # ___ rendimiento califi cacin
Title ____________________________________________________________________________
________________________________________________________________________________
Protocolo escrito por ___
Departamental aprobacin de fecha ___ de ___
Aprobacin de control de calidad de ___ de fecha ___
Objetivo
Para determinar que los sistemas y equipos realizan ha previsto ejecutar repetidamente la
sistema en su horario previsto y registrar toda la informacin relevante y datos. Resultados
debe demostrar que el rendimiento constantemente cumple con determinado especifi caciones
en condiciones normales y en su caso para las peores situaciones de caso.
mbito de aplicacin
A realizar despus de la instalacin y funcionamiento califi cacin se han completado
y aprobado.
A realizar despus de la instalacin, modifi cacin o traslado y para la revalidacin en
intervalos apropiados.
Cada pieza de equipo debe ser validada antes de que sirve otro pedazo de equipo /
sistema durante la validacin de este ltimo (por ejemplo sistema de agua antes de generador de
vapor, vapor
generador antes de autoclave).
Este formato se utiliza para adiestramiento y refl ects algunos de los contenidos posibles para un rendimiento califi Protocolo de catin.
un
166
Formato para un protocolo de rendimiento califi cacin (continuado)
un
_________________________________________________________________________________
Responsabilidad
Persona responsable del funcionamiento del sistema o equipo realizar la califi cacin
y registrar la informacin.
El supervisor supervisar el estudio, verificar la realizacin de los registros y escribir el
Informe de desviacin y la actuacin califi cacin informe.
Calificar garanta revisar y aprobar la actuacin califi cacin protocolo y
Informe.
Materiales, equipos, documentos
Poes para las operaciones normales del equipo o sistema bajo prueba (incluyendo el registro de datos
formas, grficos, diagramas materiales y equipo necesario). Adjunte copias.
Lista de SOP:
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
SOPs especfi co para pruebas de rendimiento (incluyendo formularios de registro de datos, grficos,
diagramas, materiales
y equipos necesarios, clculos y anlisis estadsticos a realizar, y
Especificaciones predeterminadas y criterios de aceptacin). Adjunte copias.
Lista de SOP:
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
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_________________________________________________________________________________
Procedimiento
Equipo: Ejecutar un procedimiento normal tres veces para cada uso (confi guracin o carga) y
registrar los datos necesarios y cualquier desviacin del procedimiento.
Sistemas: Ejecutar consecutivos de 20 das de trabajo, registro de datos necesarios y cualquier
desviaciones al procedimiento.
Preparar el formulario de registro datos de resumen (tabla 1).
Evaluacin
Adjuntar los formularios de registro de datos todo completado, firmado.
Complete el formulario de registro de datos de resumen (tabla 1).
Realizar los clculos y anlisis estadsticos (tabla 2).
Comparar con criterios de aceptacin (grfico 3).
Preparar informe de desviacin de la justifi cacin de la aceptacin y el impacto en la
rendimiento.
Preparar una Performance califi cacin informe: esto debe incluir: fecha de estudio iniciado;
fecha de finalizacin; observaciones; problemas encontrados; integridad de la informacin
recogidos; Resumen del informe de desviacin; resultados de las pruebas; resultados de aceptacin de
cumplir
criterios; Ubicacin de los datos originales; otra informacin relevante para el estudio; y las
conclusiones
sobre la validez del equipo/sistema.
Presentar desempeo califi cacin documento para control de calidad para revisin y aprobacin.
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168
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_________________________________________________________________________________
Tabla 1: Registro de datos de Resumen
(A ser preparado para el procedimiento c especifi ensayado)
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_________________________________________________________________________________
Tabla 2: Clculos y anlisis estadsticos
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170
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_________________________________________________________________________________
Tabla 3: Resultados de la prueba de aceptacin criterios vs rendimiento
Criterios de resultados pasa/no pasa
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________

__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
__________________________ ____________________________________ _____________
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_________________________________________________________________________________
Deviation(s):
Justifi cacin para la aceptacin:
Impacto en la operacin, funcin o proceso:
Escrito por: _____________________________________________ Fecha ____________
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_________________________________________________________________________________
Cacin de califi cada de rendimiento informe
Resultados:
CONCLUSIONES:
Escribe: _____________________________________________ Fecha ____________
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173
8. Requalifi
cacin

manufactura
(GMP): validacin ".
8.1 Requalifi cacin de sistemas y equipos debe hacerse de acuerdo
con una defi ned programar. La frecuencia de requalifi cacin puede ser
determinado sobre la base de factores tales como el anlisis de resultados
relativos a
calibracin, verifi cacin y mantenimiento.
8.2 debe cacin peridica requalifi.
8.3 debe existir requalifi catin despus de cambios. El grado de requalifi
cacin despus de que el cambio debe ser justifi cado basado en una
evaluacin del riesgo de
el cambio. Catin de Requalifi despus de que el cambio se debe considerar
como parte de la
cambiar el procedimiento de control.
9. califi
cacin de "en uso" sistemas y equipos
9.1 deben haber datos para apoyar y verificar el funcionamiento adecuado y

funcionamiento de sistemas y equipos que han sido "en uso" durante un
perodo
de tiempo, y que no haba sido sometido a instalacin o funcionamiento
califi cacin.
9.2 estas deben incluir parmetros y lmites de funcionamiento crtico
variables, calibracin, mantenimiento y mantenimiento preventivo, estndar
procedimientos de (trabajo PNTs) y registros de funcionamiento.
10. referencia
A quien gua de requisitos de (GMP) buenas prcticas de fabricacin.

Parte 2: validacin. Ginebra, programa Global para vacunas e inmunizacin,
Suministro de vacunas y de calidad, red de formacin Global, mundo
Organizacin de la salud, 1997 (WHO/VSQ/97.02).

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Appendix 6

Qualification of systems and equipment

1.1 Systems and equipment should be appropriately designed, located,

2.1 These guidelines describe the general aspects of qualification for

operational qualifi cation (OQ) and performance qualifi cation (PQ) as

Note: see also Supplementary guidelines on good manufacturing practices

Note: see also Supplementary guidelines on good manufacturing practices

Format for an installation qualifi cation protocol and report a

Format for an installation qualifi cation protocol and report (continued) a

Format for an installation qualifi cation protocol and report (continued) a

Format for an installation qualifi cation protocol and report (continued) a

Format for an installation qualifi cation protocol and report (continued) a

Note: see also Supplementary guidelines on good manufacturing practices

Format for an operational qualifi cation protocol (continued) a

Format for an operational qualifi cation protocol (continued) a

_____________________ ________________________ _______________________

Format for an operational qualifi cation protocol (continued) a

Format for an operational qualifi cation protocol (continued) a

_____________________ ______________________________________ _______________

Format for an operational qualifi cation protocol (continued) a

Format for an operational qualifi cation protocol (continued) a

_____________________ ______________________________________ _______________

Format for an operational qualifi cation protocol (continued) a

Format for an operational qualifi cation protocol (continued) a

Format for an operational qualifi cation protocol (continued) a

Note: see also Supplementary guidelines on good manufacturing practices

Format for a performance qualifi cation protocol (continued) a

Format for a performance qualifi cation protocol (continued) a

Prepare the Summary Data Record Form(Chart 1).

Format for a performance qualifi cation protocol (continued) a

Format for a performance qualifi cation protocol (continued) a

Format for a performance qualifi cation protocol (continued) a

__________________________ ____________________________________ _____________

Format for a performance qualifi cation protocol (continued) a

Format for a performance qualifi cation protocol (continued) a

Note: see also Supplementary guidelines on good manufacturing practices

cation of in-use systems and equipment

A WHO guide to good manufacturing practice (GMP) requirements.

Health Organization, 1997 (WHO/VSQ/97.02).

1.1 sistemas y equipos deben ser adecuadamente diseados, ubicado,

2.1 estas pautas describen los aspectos generales de calificacin para

3.1. el fabricante debe tener una poltica de calificacin para sistemas y

cacin de califi operacional (OQ) y cacin de califi rendimiento (PQ) como

las directrices sobre la califi cacin purifi cacin de sistemas de agua en el

Nota: vase tambin "directrices complementarias sobre buenas prcticas de

Nota: vase tambin "directrices complementarias sobre buenas prcticas de

5.5 debe existir registros documentados para la instalacin (instalacin

Formato para un protocolo de instalacin cualifi cacin y un informe

Formato para un protocolo de instalacin califi cacin e informe (continuada)

6. presentar el informe de control de calidad para revisin y aprobacin.

Formato para un protocolo de instalacin califi cacin e informe (continuada)

Formato para un protocolo de instalacin califi cacin e informe (continuada)

Formato para un protocolo de instalacin califi cacin e informe (continuada)

Nota: vase tambin "directrices complementarias sobre buenas prcticas de

las variables deben incluir condiciones que abarca funcionamiento superior e

6.4 debe haber registros documentados para la verifi cacin de funcionamiento

Formato para un protocolo de funcionamiento califi cacin (continuado)

Formato para un protocolo de funcionamiento califi cacin (continuado)

_ ___

_ ____ _

_ ____ _

__ _

Ttulo: Nombre del centro: ______________

__ _