Oig Process Validation

Clinical Pathology Services
Process Validation in Blood Transfusion v1.0.doc

Date of Issue: 18.10.2006
Version 1.0 THIS SOP SUPERSEDES ALL PREVIOUS ISSUES
Page 1 of 11
Process Validation in Blood Transfusion
Risk Assessment [1x1=1]

This procedure has been examined under COSHH Guidelines, Manual Handling
and VDU Regulations and has been assessed as LOW RISK if carried out as
written.
Area of CPA Standard
F1: Selection and validation of examination Procedures
THIS IS A CONTROLLED DOCUMENT AND MUST NOT BE COPIED OR

DISTRIBUTED WITHOUT AUTHORISATION
Distribution of 1. Blood Transfusion Dept
Copies:
Copy kept on
Q-Pulse
Review Interval Annually or as required
Author
Name Signed Job Title Date
BMS 4
Reviewer
Authorised by
Service Manager
Next Review Reviewed by:

Date: Name Signed Job Title Date
Introduction
STANDARD OPERATING PROCEDURE

Q-Pulse Reference: Process Validation in Blood Transfusion v1.0.doc
Page 2 of 11
Quality is recognised as of paramount importance within the Clinical Pathology

Services of XXX NHS Foundation Trust. This commitment is demonstrated by
the development of a Quality Management System, which will ensure the
provision of safe, efficacious, timely results and services for both patients and
users. Validation may be considered an extension of the Quality Management
System. It requires meticulous preparation and careful planning. All work must
be carried out according to the documented procedures to ensure that the
objectives are met.
In order to comply with regulations12 the Clinical Pathology Service recognises

that it has an obligation to generate documented records, which ensure that the
procedures, processes, equipment, materials, operations or systems actually
produce the desired result.
The adoption of a structured validation strategy which requires collaboration

between key personnel and which embraces the impact of validation on the
facility and organisation as a whole leads to:
• Delivery of a quality oriented results, which meet user expectation, is fit for
purpose, and is delivered on time and within budget;
• More cost effective implementation of facilities, equipment, systems and
processes through the structured validation methodology;
• The delivery of facilities, equipment, systems and processes which are well
defined, documented and easier to use, supported and maintained through
an obligation to address user training and produce supporting SOP’s.
Project Validation
Any validation project associated with new equipment, assays, processes,

materials, operations or systems should be first discussed within the
departments’ validation/quality team. The team should then assign project
responsibility to members consisting of:
Project Manager/ Quality Manager: is the person with overall

responsibility for the successful completion of the project. They are
responsible for signing off the validation on completion. A report on the
study should be produced and is the responsibility of the Project Manager
and should have the support of those identified in the protocol design
Project Leader: has overall responsibility for organisational aspects of

the work including production of the protocol, data collection and
analysis, writing the final report and ensuring that there is peer group
assessment of protocol and report. The Project Leader may also be the
Project Manager.

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Project Team: includes people with sufficient expertise to cover all

aspects of the method involved. The size of the project group can range
from as little as one person, i.e. the Project Leader (if the individual
performing the validation has sufficient expertise in all aspects of the
project area) to many. The basis of the team could be the departmental
Quality Team or, if required, the building of a totally new team. It may be
necessary to include people form other laboratories to ensure sufficient
expertise is available for a successful evaluation/validation to be
conducted. It might be useful to include the departments’ designated IT
person to evaluate interfacing, printing and LIMS compatibility.
Project Validation Plan
Once the team members have been identified the project requires a Validation
Plan. Validation is a pre-defined exercise to ensure that equipment; facilities,
systems, processes or procedures are fit for purpose and meet their pre-defined
specifications. This plan should take into consideration Good Testing Practise
(see appendix 2).
The complexity of the plan will depend on the circumstances. The validation
approach can follow a number of methods
1. Prospective Validation: Validation carried out prior to a new facility, piece

of equipment, assay, kit, process or system being introduced.
Prospective validation may also be implemented when a critical change
has been made to any of the above already in use; validation is
completed before they are re-introduced back into general use.
2. Retrospective Validation: Validation carried out on a well established

piece of equipment, assay, kit etc.. This validation is based on historical
data, which must be adequately specific. It is inappropriate to use this
method of validation where there have been recent changes to the assay
etc.
The team need to discuss the nature of the validation and decide if it requires
full validation or a more simple method validation.
The complexity of the project will depend on the situation. Two strategies can be
considered when developing a Validation Plan, depending on the nature of the
project.
1. Simple Method Validation

Page 4 of 11
This process should be followed when introducing a new assay or

reagent into the laboratory. It should also be used when an assay/
method needs retrospective validation following vertical audit
failure. Follow GENMANPR013 Method Validation
2. Full Process Validation
Full Process Validation
Process Validation Plan
The Process Validation Plan should follow the pathway set out in Appendix 1
The Plan should include the following
Introduction:
This should define the purpose and objectives of the investigation. A brief
description of the principal functions of the equipment/assay being validated and
refer to any user requirement specifications (these describe what the
system/assay etc… is intended to do and may be part of the procurement
process).
User Requirement Specification (URS)
This describes what the facility, equipment, system or process is intended to do

and all essential requirements such as turnaround times, throughput,, operating
ranges, limits of detection, cv’s etc., that we require the equipment/assay to
achieve. It may be part of the procurement process that is sent out to a
manufacturer or it may be an internal requirement for an assay or method must
achieve.
Approval Page: This serves to verify that the Validation plan has been formally
approved and to authorise the completed Validation Project. The approval page
consists of 3 sections
1. This serves to formally approve that the Validation Plan is correctly

compiled to allow validation to begin. The Validation Plan must be
approved before validation testing commences.
This section will contain the signatures of those responsible for
writing, reviewing and authorising the VP. The approval signatories
Page 5 of 11
must be defined before validation begins. The Quality Manager must

give final Validation Plan approval.
2. This serves to show that formal approval has been given to move
from each stage of qualification to the next (i.e. OQ to move to PQ).
Deviations from a completed phase should be closed prior to
beginning the next phase of work unless the outstanding deviation is
very minor However, this must be documented.
3. This serves to give formal approval that the validation project has
been successfully completed and that the facility, equipment, process
or system is validated and authorised for routine use. In the case of
prospective validation authorisation must be given before the
facility, equipment, process or system is introduced into routine
use.
This section will contain the signatures of those responsible for

reviewing and giving final approval of the validation project.
Functional Specification (FS)
This is normally written by the supplier in response to the URS and describes
the detailed function of the equipment, systems etc.. (i.e. describes what the
equipment/system will do)
Design Specification (DS)
Again normally written by the supplier and should contain sufficient detail to
enable the equipment/system to be built and maintained. It is acceptable to
incorporate the FS and DS into one document.
NB For “Ready made” equipment or system the supplier may not submit an FS
or DS. They should however, submit literature, which clearly defines the
features of the equipment or system. This should be carefully checked and
verified that the equipment/system/assay is capable of performing to the
required standard for its intended purpose.
Installation of Equipment.

Page 6 of 11
All equipment installed in the laboratory must first be safety checked following
the trust policy xxxxxxxxxxxxx. Once installed IQ,OQ and PQ should be
performed prior to any method validation being performed.
Installation Qualification (IQ)
Simply put IQ means, has it been installed properly? The use of the checklist
(GENMANFO018) can be used to complete this phase
Operational Qualification (OQ)
In this phase of the plan we test the system/assay etc… to investigate if the
product meets the defined requirements (accuracy of the assay). If possible it is
desirable to test the system under all anticipated conditions (worst testing).
Maintenance and cleaning arrangements should be included and all SOP’s
written/signed off. Training and competency assessment must be designed,
added to departmental competency assessments and all staff performing the
task deemed competent before proceeding to the PQ. The OQ must be
complete and signed off prior to moving to PQ.
Performance Qualification (PQ)
In this phase the key objective is to demonstrate the process will consistently
produce acceptable performance under normal operating conditions. This
should be used in conjunction with method validation below in assessing the
precision, accuracy, robustness, reproducibility and linearity etc…
Method Validation
Method validation looks at the ability of an assay to meet pre-designated targets

as found in GENMANPRO013 Method Validation.
VALIDATION SUMMARY REPORT
Validation reporting requirements vary greatly depending on the size and scale
of the validation project. However, whatever the extent of the project, there is
always the requirement to issue a final validation report, which summarise the
entire project, concludes the system is validated and clearly signifies
acceptance of the conclusions by the user and Quality team.
The final validation summary report will be taken to the Quality meeting to be
ratified by the team and signed off by the Project Manager/Quality Manager (this

Page 7 of 11
can be signed outside the meeting for faster implementation but must be
formally discussed at the QA meeting).
Related documentation
GENMANPR013 Method Validation

GENMANPR014 Production Implementation Amendment and
Withdrawal of Standard Operating Procedures)
The Fitness for Purpose of Analytical Methods
Evaluation, validation and implementation of new blood grouping
techniques. Transfusion Medicine (1995) 5:145-15
GENMANPR051 Change Control Procedure
The Blood Safety and Quality Regulations SI 2005/50
EUDRALEX Volume 4 - Medicinal Products for Human and
Veterinary Use: Good Manufacturing Practice
Cross References
• ISO/FDIS 15189 5.5 Examination procedures

5.6 Assuring the quality of examination procedures
• ISO/IEC 17025:2000 5.4 Test and method validation
• ISO/DIS 9001(E) 7.2 Customer Related Processes
7.3 Design and/or development
7.5.5 Validation of Processes
• EC4 Essential Criteria 8.1 Validation
8.2 Calibration and traceability of methods

Page 8 of 11
Appendix 1
Project Discussed
at QualityMeeting
Project Team
Analyser/Equipment Assay/Reagent
Defined
Full Process
Method Validation
Validation
Project Plan/
Project Plan
Testing Protocol
May be part of the

Procurement Process
User Requirement
Specifications Describes what the equipment/analyser is
URS intended to do i.e. essential requirements, Validation File
operating ranges etc.. Produced
These are normally written by the supplier in

Functional / response to the URS and may be incorporated
Design into one document
Specification
FS + DS Functional Spec: Detailed
function of the equipment
Design Spec: Detailed
Verifies equipment design Validation Process
URS Signed Off
Verifies DS Includes electrical
Verifies Installation of Testing and asset
FS Equipment register
IQ: Documented evidence that installed

Installation Qualification IQ according to design (support from supplier may
be necessary)
OQ: Documented evidence that the equipment

Operational Qualification OQ functions correctly (support from supplier may
be necessary)
PQ:Documented evidence
Performance Qualification PQ
that the URS have been met
Appendix 2
Page 9 of 11
Good Testing Practice
The use of good testing techniques ensures that tests cover all relevant and
critical aspects of a facility, piece of equipment, process, cleaning method or
system, and that the tests are executed and documented well enough to enable
tracing of the test, the test results, the handling of deviations and the
responsible persons for each activity.
Tests should refer to the specifications and requirements they are testing
Good Testing Practice requires that:
• Tests are executed according to a pre-defined and pre-approved test
protocol, which is established on the appropriate facility, piece of
equipment, process, cleaning method or system.
• Testing must not start before the test protocol has been approved.
• Tests must cover all relevant and more importantly, critical areas of the
facility, piece of equipment, process, cleaning method or system. They
must be planned and executed by trained and qualified persons. Staff
executing validation tests must be trained in and have sufficient
knowledge of the facility, piece of equipment, process, cleaning method
or system being validated..
• The test procedure should be described in sufficient detail to enable
repetition of the test and should refer to the relevant specifications.
• All test documentation should show date and signature on each test by
the tester and witness and reviewer. There should be pre-determined
acceptance criteria or statements of expected results for each test.
• During execution, test results should be recorded directly onto test results
sheet or refer to printouts or computer generated test execution files (e.g.
screen printouts) with a clear document reference. Such additional test
documentation should be signed, dated and marked with unique
reference to the relevant test.
• The test documentation and results, including original observations and
activities, should be kept
• Manual test recording should be legible. Shorthand notations such as tick
marks should be avoided and actual values should be recorded wherever
possible. If tick marks are applied at certain tests, there should be a
description of exactly what is meant. Records should be complete and
marks, such as “ditto marks” or arrows are not sufficient. If sections of a
test record are not completed, they should be clearly marked as not
applicable with a short explanation to demonstrate that the test execution
has been complete.
• Corrections should be crossed out with a single line (leaving the original
content readable), initialled and dated with a brief explanation. Correction
fluid and other correction techniques that obscure the original entry
should not be used.
• Each test should be concluded with a statement of whether the test has
met its acceptance criteria.
Page 10 of 11
• All deviations should be recorded and be traceable throughout correction

and retesting to resolution.
• Critical instrument inputs and any test equipment should be calibrated.
Documented evidence of such calibration, traceable to appropriate
standards is required. Calibration equipment should be certified.
• Any reference samples used must be described in detail. If appropriate
the testing or calibration of reference samples should also be described
• After test execution the results should be reviewed for correctness and
completeness. This review process should ensure that all testing has
been completed, that all relevant documents are included, that the
acceptance criteria are fulfilled and that all deviation records are included
I have read, understood and agree to follow the procedure as written:
Name of Staff Signature of Staff Date

Page 11 of 11
1
Clinical Pathology Accreditation (UK) Ltd. Standards for the Medical laboratory. Sheffield 2004.
Standard F1 “Selection and validation of examination procedures.
2
The Blood safety and Quality Regulations 2005 (SI2005/50)


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Clinical Pathology Services

Process Validation in Blood Transfusion v1.0.doc

Process Validation in Blood Transfusion

Risk Assessment [1x1=1]

Area of CPA Standard

F1: Selection and validation of examination Procedures

THIS IS A CONTROLLED DOCUMENT AND MUST NOT BE COPIED OR

Review Interval Annually or as required

Next Review Reviewed by:

STANDARD OPERATING PROCEDURE

Quality is recognised as of paramount importance within the Clinical Pathology

In order to comply with regulations12 the Clinical Pathology Service recognises

The adoption of a structured validation strategy which requires collaboration

Any validation project associated with new equipment, assays, processes,

Project Manager/ Quality Manager: is the person with overall

Project Leader: has overall responsibility for organisational aspects of

STANDARD OPERATING PROCEDURE

Project Team: includes people with sufficient expertise to cover all

Project Validation Plan

1. Prospective Validation: Validation carried out prior to a new facility, piece

2. Retrospective Validation: Validation carried out on a well established

1. Simple Method Validation

STANDARD OPERATING PROCEDURE

This process should be followed when introducing a new assay or

2. Full Process Validation

Full Process Validation

Process Validation Plan

User Requirement Specification (URS)

This describes what the facility, equipment, system or process is intended to do

1. This serves to formally approve that the Validation Plan is correctly

must be defined before validation begins. The Quality Manager must

This section will contain the signatures of those responsible for

Functional Specification (FS)

Design Specification (DS)

STANDARD OPERATING PROCEDURE

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ)

Method validation looks at the ability of an assay to meet pre-designated targets

VALIDATION SUMMARY REPORT

STANDARD OPERATING PROCEDURE

GENMANPR013 Method Validation

• ISO/FDIS 15189 5.5 Examination procedures

STANDARD OPERATING PROCEDURE

May be part of the

These are normally written by the supplier in

IQ: Documented evidence that installed

OQ: Documented evidence that the equipment

Good Testing Practice

• All deviations should be recorded and be traceable throughout correction

I have read, understood and agree to follow the procedure as written:

Name of Staff Signature of Staff Date

STANDARD OPERATING PROCEDURE

STANDARD OPERATING PROCEDURE

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