CELEBRITY BIOPHARMA LIMITED

Format No.: QAS001/F/01/00 Reference SOP No.: SOP/QA/001/00

STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/037/00
Version 00
Superseded SOP No. Nil
Title Equipment Qualification and Validation Effective Date
Review Date
Page Number 1 of 10

1. OBJECTIVE
1.1 To establish a procedure to evaluate vendors / suppliers who supply material conforming to
specified requirements guideline for qualification and validation activities carried out to
demonstrate suitability for routine processing of equipment, area and system.
2. SCOPE
2.1 This procedure is applicable to qualification and validation of Equipment at Celebrity
Biopharma Limited.
3. RESPONSIBILITY
3.1 Purchase department shall search the suitable vendor for requirements of products.
3.2 QC department shall analyze the pre-dispatch samples.
3.3 QA department shall Vendor audit, vendor evaluation and blacklist the vendor as per
requirement.
3.4 QA Head shall responsible for compliance with this procedure.
4. PROCEDURE
4.1 Definitions:
4.1.1 Validation:
Validation is the documented evidence which provides high degree of assurance
that the process, utility, material which produce the product at a pre-determined
specifications and quality attributes.
4.1.2 Prospective Validation:
Validation carried out during the development stage by means of a risk analysis of
the production process, which is broken down into individual steps, these are then
evaluated on the basis of past experience to determine whether they may lead to
critical situations.

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 CELEBRITY BIOPHARMA LIMITED
Format No.: QAS001/F/01/00 Reference SOP No.: SOP/QA/001/00
STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/037/00
Version 00
Superseded SOP No. Nil
Title Equipment Qualification and Validation Effective Date
Review Date
Page Number 2 of 10

4.1.3 Concurrent Validation:

Validation carried out during routine production of products intended for sale.
4.1.4 Retrospective Validation:
Involves the examination of past experience of production on the assumption that
composition, procedure and equipment remain unchanged.
4.1.5 Re-Validation:
Repeated validation of an approved process (or a part thereof) to ensure continued
compliance with established requirements.
4.1.6 Validation Protocol:
A validation protocol is a written plan stating how validation will be conducted,
including test parameters, product characteristics, and production equipment and
decision points on what constitutes acceptable test results.
4.1.7 Validation Report:
A validation report is a written report on the validation activities, the validation
data and the conclusions drawn.
4.1.8 Qualification:
The planning, execution and recording of tests of equipment and systems that
forms part of the validated process, to demonstrate that it will perform as intended.
4.1.9 User Requirement Specification (URS):
A requirement specification that describes what the equipment or system is
supposed to do, thus containing at least a set of criteria or conditions that have to
be met.
4.1.10 Design Qualification (DQ):
Documented evidence that the premises, supporting utilities, equipment and
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 CELEBRITY BIOPHARMA LIMITED
Format No.: QAS001/F/01/00 Reference SOP No.: SOP/QA/001/00
STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/037/00
Version 00
Superseded SOP No. Nil
Title Equipment Qualification and Validation Effective Date
Review Date
Page Number 3 of 10

processes have been designed in accordance with the User Requirement

specifications of cGMP.

4.1.11 Installation Qualification (IQ):

IQ is the documentary evidence to verify that the equipment has been built and
installed in compliance with the design specifications.
4.1.12 Operational Qualification (OQ):
OQ is the documentary evidence to verify that the equipment operates in
accordance with its design specifications in its normal operating range and
performs as intended throughout all anticipated operating ranges.
4.1.13 Performance Qualification (PQ):
PQ is the documentary evidence to verify that the equipment or system performs
consistently and gives reproducibility within defined specifications and parameters
for prolonged period.
4.1.14 Re-qualification:
Re-qualification is done to ensure that changes in the process and / or in the
process environment whether intentional or unintentional, do not adversely affect
process characteristics and product quality.
4.2 Equipment qualification involve the following:
4.2.1 User Requirement Specification (URS)
4.2.2 Design Qualification (DQ)
4.2.3 Installation Qualification (IQ)
4.2.4 Operational Qualification (OQ)
4.2.5 Performance Qualification (PQ)

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 CELEBRITY BIOPHARMA LIMITED
Format No.: QAS001/F/01/00 Reference SOP No.: SOP/QA/001/00
STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/037/00
Version 00
Superseded SOP No. Nil
Title Equipment Qualification and Validation Effective Date
Review Date
Page Number 4 of 10

4.2.6 Re-Qualification
4.3 User Requirement Specification (URS):
4.3.1 URS shall be prepared by the user department head in consultation with the
validation team members.
4.3.2 URS shall contains but not limit to objective, scope, process or product
requirement, operational requirement, GMP requirement, safety requirement,
documentation requirement, service required from the manufacturers, references
(if any), documents to be attached, abbreviations, summary, conclusion and
signing off.
4.3.3 A copy of URS shall be sent to different equipment manufacturers for availability
of required equipment and technical specifications of the equipment.
4.4 Design Qualification (DQ):
4.4.1 In Design Qualification the User Requirement Specification should be finalized
based on the technical specification of the selected supplier and URS.
4.4.2 The DQ protocol and report shall contains objective, scope, site of study,
validation team members, description of equipment, equipment required for,
general requirements, system description, technical specification, safety
requirements, utility requirements, material of construction of product contact
parts and non-contact parts, abbreviation, conclusion, design certification
statement and design qualification signing off.
4.4.3 After the approval of DQ report, a copy of DQ along with the purchase order shall
be sent to the selected equipment manufacturer for designing of the equipment.
4.5 Installation Qualification (IQ):
4.5.1 Installation Qualification shall include the documentation of maintenance
requirement for each installed item and the collection and collation of supplier
operating and working instructions, maintenance and cleaning requirements, these
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 CELEBRITY BIOPHARMA LIMITED
Format No.: QAS001/F/01/00 Reference SOP No.: SOP/QA/001/00
STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/037/00
Version 00
Superseded SOP No. Nil
Title Equipment Qualification and Validation Effective Date
Review Date
Page Number 5 of 10

shall be the minimum documentation for a satisfactory installation qualification.

4.5.2 It shall require a format and systemic check of all installed equipment components
against the equipment manufacturer's specifications and additional criteria
identified by the user as part of the purchase specification.
4.5.3 Equipment shall be checked with respect to general requirements, critical variables
and safety features
4.5.4 It shall contain the identification of critical component / instrument, verification of
manufacturer's calibration certificates of all measuring devices of the equipment
and test certificates for material of construction.
4.5.5 All Stainless Steel Material of Construction (MOC) of the equipment for product
contact parts and product Non-Contact parts shall be verified using Molybdenum
test kit.
4.5.6 Any deviations observed during Installation Qualification shall be captured and
justified by the validation team in the individual IQ report.
4.5.7 Change control (if any) should be approved and shall be captured in the IQ report.
4.5.8 The IQ protocol and report shall contain but not limit to objective, scope, site of
study, validation team members, description of equipment, general requirements,
pre-installation checks, installation checks, identification of critical components
for calibration, verification of safety features, references (if any), abbreviations,
documents to be attached, any changes made against the formally agreed
parameters , conclusion, installation certification statement and installation
qualification signing off.
4.5.9 After completion of the Installation Qualification tests and IQ report is signed off,
Operational Qualification test shall be initiated.
4.6 Operational Qualification (OQ):
4.6.1 The equipment shall be verified with respect to its operational requirements,
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 CELEBRITY BIOPHARMA LIMITED
Format No.: QAS001/F/01/00 Reference SOP No.: SOP/QA/001/00
STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/037/00
Version 00
Superseded SOP No. Nil
Title Equipment Qualification and Validation Effective Date
Review Date
Page Number 6 of 10

critical variables and safety features.

4.6.2 The critical variables such as speed, Voltage, Current drawn etc. shall be verified
for three consecutive readings during operational confirmation.
4.6.3 All critical components of the equipment shall be calibrated by the approved
external agency.
4.6.4 The details of instrument used for verifications, such as instrument name,
identification number and calibration status shall be recorded in the qualification
report. A copy of calibration certificate of the instruments used for verification
shall be enclosed to the operational qualification report.
4.6.5 The SOP's for equipment, Operation, Cleaning and Preventive Maintenance shall
be prepared and training for all concerned personnel shall be imparted.
4.6.6 The Preventive Maintenance Plan and Calibration plan shall be updated to include
the new equipments / system for routine preventive maintenance and calibration
activity.
4.6.7 Any deviations observed during the Operational Qualification shall be captured
and justified by the validation team in the individual OQ report.
4.6.8 Change control (if any) should be approved and shall be captured in the IQ report.
4.6.9 The OQ protocol and report shall contains but not limit to objective, scope, site of
study, validation team members, description of equipment, general requirements,
calibration details, pre-operational checks, operational checks, safety parameter
checks, standard operating procedure details, training details, references (if any),
abbreviations, documents to be attached, any changes made against the formally
agreed parameters, conclusion, operational certification statement and operational
qualification signing off.
4.6.10 After completion of the Operational Qualification tests and OQ report is signed
off, Performance Qualification test shall be initiated.

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 CELEBRITY BIOPHARMA LIMITED
Format No.: QAS001/F/01/00 Reference SOP No.: SOP/QA/001/00
STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/037/00
Version 00
Superseded SOP No. Nil
Title Equipment Qualification and Validation Effective Date
Review Date
Page Number 7 of 10

4.7 Performance Qualification (PQ):

4.7.1 During Performance qualification the working of the system as a whole should be
checked with respect to output, quality and any specific requirement as per design
qualification.
4.7.2 In PQ simulated product/ products shall be used to conduct the performance
qualification. Studies on the critical variables shall include a condition or as set of
conditions encompassing upper and lower processing or operating limits and
circumstances commonly referred as “worst case” conditions.
4.7.3 Three consecutive batches / runs shall be carried out for satisfactory completion of
performance qualification.
4.7.4 Any deviations observed during the Operational Qualification shall be captured
and justified by the validation team in the individual OQ report.
4.7.5 Change control (if any) should be approved and shall be captured in the IQ report.
4.7.6 The PQ protocol and report shall contains but not limit to objective, scope, site of
study, validation team members, description of equipment, SOP to be followed,
pre-performance checks, performance checks, abbreviation, document to be
attached, any change made against the formally agreed parameters, conclusion,
performance certification statement and performance qualification signing off.
4.7.7 After completion of the Performance Qualification test and PQ report is signed off
the equipment shall be released for its intended use
4.8 Re-Qualification: Re-qualification area of two types:
4.8.1 Re-qualification after change:
4.8.1.1 Equipment should be subjected to re-qualification whenever major
changes are made or equipment is relocated.
4.8.1.2 Re-qualification after changes should be performed when these changes

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 CELEBRITY BIOPHARMA LIMITED
Format No.: QAS001/F/01/00 Reference SOP No.: SOP/QA/001/00
STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/037/00
Version 00
Superseded SOP No. Nil
Title Equipment Qualification and Validation Effective Date
Review Date
Page Number 8 of 10

could have an effect on the quality of the product or the product

characteristics.
Examples of major changes which require re-qualification are:
 Change in RPM of Blender.
 Change in agitator speed.
4.8.1.3 The extent of re-qualification will depend on the nature and significance
of the changes. This will be decided by the validation team.
4.8.1.4 The re-qualification need not to be performed for the minor changes in
the equipment / area.
4.8.1.5 All changes in equipment should be recorded in the machine History
Card.
4.8.1.6 If any fixed equipment is shifted from one area to another area, critical
parameters should be checked during re-qualification. Transfer note
should be made for the equipment and it should be kept along with re-
qualification record. For the relocation of portable equipment, re-
qualification is not required.
4.8.1.7 During the transfer of equipment from one unit to another unit, re-
qualification of IQ, OQ, PQ should be conducted based on critical
parameters. A copy or original qualification should be attached as
reference.
4.8.1.8 Any change in equipment leading to re-qualification should go through
a change control procedure with proper justification for change.
4.8.2 Periodic Re-qualification:
4.8.2.1 Based on the extent of validation required, the data available for
reasonable period (sufficient to prove consistency) may be reviewed and
equipment put in use with ongoing validation in progress. Additional

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 CELEBRITY BIOPHARMA LIMITED
Format No.: QAS001/F/01/00 Reference SOP No.: SOP/QA/001/00
STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/037/00
Version 00
Superseded SOP No. Nil
Title Equipment Qualification and Validation Effective Date
Review Date
Page Number 9 of 10

checks and control may be incorporated during the period. This process
of interim use needs to be approved by Head QA.
4.8.2.2 Equipment should be subjected to re-qualification in accordance with a
defined schedule available at the unit and recorded.
4.8.2.3 Frequency of periodic Re-qualification should be decided based on
critical monitoring parameters and it should not exceed 5 years
4.9 Numbering System for Qualification and Validation Documents:
4.9.1 Numbering of Qualification, Requalification, Validation and Revalidation protocol
shall be done as per SOP of Master Document Numbering, SOP No.:
SOP/QA/042/00.

5. RELATED DOCUMENTS
5.1 SOP No.: SOP/QA/042/00 : Master Document Numbering System
6. REFERENCES
6.1 Nil
7. RECORDS
7.1 Nil
8. ABBREVIATIONS
8.1 SOP : Standard Operating Procedure
8.2 QA : Quality Assurance
8.3 MOC : Material of Construction
8.4 URS : User Requirement specification

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 CELEBRITY BIOPHARMA LIMITED
Format No.: QAS001/F/01/00 Reference SOP No.: SOP/QA/001/00
STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/037/00
Version 00
Superseded SOP No. Nil
Title Equipment Qualification and Validation Effective Date
Review Date
Page Number 10 of 10

8.5 DQ : Design Qualification

8.6 IQ : Installation Qualification
8.7 OQ : Operational Qualification
8.8 PQ : Performance Qualification
8.9 cGMP : Current Good Manufacturing Practices
9. REVISION RECORD
Version Reason for Revision Effective Date
00 New SOP ---------

END OF DOCUMENT

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