Oig Process Validation
Oig Process Validation
Oig Process Validation
Copy kept on
Q-Pulse
Author
Name Signed Job Title Date
BMS 4
Reviewer
Name Signed Job Title Date
Authorised by
Name Signed Job Title Date
Service Manager
Introduction
• 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
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
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.
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).
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
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 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)
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.
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.
Simply put IQ means, has it been installed properly? The use of the checklist
(GENMANFO018) can be used to complete this phase
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.
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
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
can be signed outside the meeting for faster implementation but must be
formally discussed at the QA meeting).
Related documentation
Cross References
Appendix 1
Project Discussed
at QualityMeeting
Project Team
Analyser/Equipment Assay/Reagent
Defined
Full Process
Method Validation
Validation
Project Plan/
Project Plan
Testing Protocol
PQ:Documented evidence
Performance Qualification PQ
that the URS have been met
Appendix 2
STANDARD OPERATING PROCEDURE
Q-Pulse Reference: Process Validation in Blood Transfusion v1.0.doc
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 9 of 11
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.
STANDARD OPERATING PROCEDURE
Q-Pulse Reference: Process Validation in Blood Transfusion v1.0.doc
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 10 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)