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[ 1 ] [ 1 ] CONFIDENTIAL Documentation Requirements and Best Testing Practices for Validation and Verification Jorge A. Cordero-Monroig; BSChE, MBA-GM Validation Site Leader B+L Greenville Solutions Plant
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[ 1 ][ 1 ]CONFIDENTIAL
Documentation Requirements and Best
Testing Practices for Validation and
Verification
Jorge A. Cordero-Monroig; BSChE, MBA-GM
Validation Site Leader
B+L Greenville Solutions Plant
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Documentation Requirements and Best Testing Practices for Validation and Verification
The objective of this workshop is to provide a guidance of
when use validation/qualification protocols versus verification
test and how define the minimum requirements for a project.
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Agenda:
Concepts and Definitions
Documentation Requirements
Best Testing Practice
Interactive Exercise: Using real life examples, participants will study how to determine when use validation versus verification test and define the minimum requirements to be tested
Bonus Material
Q&A
Documentation Requirements and Best Testing Practices for Validation and Verification
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Concept and Definitions
Validation is the process that assures that a system, manufacturing process, method, or product meets the intended purpose. Validations are typically a combination of several qualifications
• E.g. Manufacturing line validation, product validation, Calibration management Software, etc…
Qualification is the process that demonstrates that an equipment has been installed properly and works as intended meeting the expected acceptance criteria.
• E.g. filler, capper, labeler, cartoner, etc…
Documentation Requirements and Best Testing Practices for Validation and Verification
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Concept and Definitions
Equipment/System Verification Test is a document that test a specific feature of the equipment, process, and/or system (example installation of an additional instrument or additional screen view, etc.). The change should be approved under a change control request and the criticality of the change is evaluated by member(s) of the change control team. All verification tests shall be archived with the applicable change control package.
Process Verification Test is a document that confirms that a specific process criterion was met using confirmatory runs and it is based on risk assessment results, performed as part of the change control.
Documentation Requirements and Best Testing Practices for Validation and Verification
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Concept and Definitions
Impact Assessment (IA) is the document that define the system / equipment criticality (Direct , Indirect, or No Impact). This document is the key to develop the risk based approach for the entire project.
Documentation Requirements and Best Testing Practices for Validation and Verification
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Documentation Requirements
Minimum requirements
Templates and sections
Approval and responsibilities
Documentation Requirements and Best Testing Practices for Validation and Verification
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Minimum requirements – Validation/Qualification protocol:
This table provides recommendations and the minimum test that
should be included in a new qualification protocol for critical systems.
The tests can be added or deleted depending on the complexity of
the equipment/system.Minimum Requirements
IQ 1. Manuals
2. Utilities
3. Drawings
4. Test Instrument Calibration
5. Major Components
6. Spare Parts (as applicable)
7. Instrument Installation Verification
8. Preventive Maintenance Verification
9. Product Contact Verification (as applicable)
10. Lubricants (as applicable)
11. EHS+S Safety Verification
12. Standard Operating Procedures
13. Software Installation Verification (as applicable)
14. Hardware Installation Verification (as applicable)
15. Inputs/Output Verification (as applicable)
OQ 1. Operational Tests
2. Alarms and Interlocks (as applicable)
3. Cycle Verification (as applicable)
4. Limit Testing (as applicable)
5. Test Instrument Calibration
6. EMI/RFI Testing (as applicable)
7. Backup and Restore (as applicable)
8. Power Failure
9. Screen Verification (as applicable)
10. Loss Communication
11. Security Access/Edit Configuration (as
applicable)
12. Temperature Uniformity Chamber (as applicable)
Documentation Requirements and Best Testing Practices for Validation and Verification
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Minimum requirements – Verification Test:
Must be managed under change control process.
It should be linked with an impact assessment.
No validation number will be assigned. The verification test will be tracked with the applicable change control number and filed with the change control documentation.
Covers the test and requirements established in the Impact assessment
Documentation Requirements and Best Testing Practices for Validation and Verification
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Templates and sections - Protocol
Validation/Qualification protocol sections may vary per company but at least the following concepts should be included as part of the protocol template:
Cover page with title, protocol number and revision number, company logo, author, and date.
Pre-approval signatures with author, engineering (if applicable), area owner, validation and QA (QC and Micro Labs as applicable)
Table of content
Introduction – Objective, Scope, Description
Components, materials, critical parameters
Qualification strategy (what and how will be tested)
General acceptance criteria
Test (Installation, Operational, Performance, Process as applicable)
Documentation Requirements and Best Testing Practices for Validation and Verification
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Templates and sections – Summary or Final Report
Validation/Qualification protocol summary report sections may vary per company but at least the following concepts should be included as part of the report template:
Cover page with protocol title and number, revision number, company logo, author, and date.
Post-approval signatures with same functional approvers than the protocol.
Qualification Summary – Purpose of the report, outcome of the validation/qualification execution, summary of discrepancies/deviation and any other event.
Qualification results by test – IQ, OQ, PQ, or PPQ test (as applicable)
Discrepancies and events in detail
Conclusion and Disposition of the validation – Clear statement that the Equipment/Facility/System/Process (EFSP) is considered validated/qualified for the intended use.
Documentation Requirements and Best Testing Practices for Validation and Verification
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Templates and sections – Verification Test
Verification Test may vary per company but at least the following concepts should be included as part of the verification template:
Change Control number and title in the header.
Objective.
Overall acceptance criteria
Test Procedure
Instrument calibration verification – document any instrument used during the test and provide copy of the current calibration.
Test with Specified, As found, Pass/Fail and performed by information.
Overall A/C meet yes or no, discrepancy yes or no, and number (as applicable).
Comment area
Reviewed by and Approved By area
Documentation Requirements and Best Testing Practices for Validation and Verification
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Approval and responsibilities – Validation / Qualification Protocols
Managed by the validation department.
Can be driven by change control request due to capital projects, new product, or major changes in critical EFSP.
Validation or vendor group should develop and execute the protocols, and generate the summary/final reports. (Gaps analysis is highly recommended for vendor protocols)
Protocol approvers – area owner, engineering, stakeholders, validation, and quality.
Engineering, area owner, and/or vendor groups needs to provide requirements and specifications.
Any person executing and/or documenting in the protocol must follow good documentation practices (GDP).
Data integrity should be required all the time.
Understand and Know How to Effectively Use Key Risk Tools
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Approval and responsibilities – Verification Test
Managed under change control and linked to an impact assessment previously approved by Validation, Area Owner, and Quality; therefore pre-approval of Verification test is not required.
Validation group or engineering group will develop the verification test including the items and requirements established in the Impact assessment.
Validation group or personnel with more expertise will execute the verification test following GDP.
The verification test will be verified by validation personnel and approved by QA representative.
Validation personnel will attach the Verification test to the Change Control.
Data integrity should be required all the time.
Documentation Requirements and Best Testing Practices for Validation and Verification
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Best Testing Practice
SOPs and Guidance
Intended Purpose and critical parameters
General test versus specifics
When validation and when verification
Documentation Requirements and Best Testing Practices for Validation and Verification
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SOPs and Guidance
SOPs are the most simple and easy way to establish and define rule for validation, qualification, and verification test. (e.g. SOP’s for Compounding, Purge, Cleaning, etc…)
Guidance is a great source for reference. They provide industry standards and are typically reviewed by the FDA. (E.g. ISPE, ISO, USP, etc…)
Intended Purpose and critical parameters
One of the most important questions that we need to answer prior to develop a test and decide between Validation/Qualification test and Verification test are
What is the intended purpose of the EFSP?
What are the critical process parameters/critical attributes?
What is the change and how impact the intended purpose of the EFSP and its operational parameters?
Documentation Requirements and Best Testing Practices for Validation and Verification
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General test versus specifics
After define the intended purpose and the critical parameters we need to define what need to be tested and what will be the acceptance criteria.
Define specific tests that will verify the critical parameters and proof that the EFSP consistently meets the acceptance criteria. (e.g. Vision system: missed cap reject rate of 1% (99% reliability) at a confidence level of 95% would have a sample size of 299 bottles)
It is a good practice to establish and pre-define general test that will not typically change or the change are in content but not in template between projects. {help to standardize and speed up process}
IQ: Document verification, Drawings, Utilities, etc…
OQ: Back-up, Power failures, EMI/RFI, Calibration, Limit testing (max/min speed, ranges), Reject capabilities, Alarms and Interlocks, Security Access, etc..
PQ: Extended run (cosmetic defect, AQL, overall performance)
PPQ: Typically is specific per type of project but requirements can be pre-define.
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General test versus specifics (Cont.)
Every EFSP will have their own specific test. However, we can establish what are the minimum specific requirements for each type of EFSP that is in the plant. For Example:
Steam Sterilizer:
1. IQ: Minimum requirements.
2. OQ: Minimum requirements; Three consecutive Full Cycle Thermal Distribution Studies
3. PQ: Three consecutive Fractional (Half) Cycles with Biological Challenge, Three consecutive Full Cycle Cool Point Determinations
Sterile Compressed Air
1. IQ: Min. requirements, points of use verification, filter verification, instrumentation (PI and Regulators / valves), Compressor (make, model/type, capacity, spare parts, utilities, etc.).
2. OQ: Min. requirements
3. PQ: Viable and Non-Viable, pressure, dew point (moisture), and TOC (oil).
Documentation Requirements and Best Testing Practices for Validation and Verification
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General test versus specifics (Cont.)
Vision System
1. IQ: Min. requirements, Station Inst. Parameters Verification and Environmental Verification.
2. OQ: Min. requirements, Self-Diagnostic and Boot-Up Test Verification, False Reject Verification, Inspection/Rejection
Station Test, and Audit Log (System Security and Purge).
Solution Lines (including piping, Unscrambler, Filler, capper, plugger and vibratory bowl)
1. IQ: Min. requirements, Material of Constructions, Cleanability, Change Parts
2. OQ: Min. requirements, Operation runs (worst case configurations or matrix) to full speed, Challenge of critical process
parameters (e.g. line speed, etc.).
3. PQ: Cleaning Validation for worst case solution at worst case contact time; Media Fills; Steam In Place studies.
4. PPQ: Conduct filling and purge runs per product, configuration or family product.
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When validation and when verification
Rules should be pre-defined in local SOPs and should be based on Risk Analysis.
Validation/Qualification
Introduction of new EFSP or products.
Major changes in critical aspect of the EFSP (Software change, major components change, change in formulation method, change in container configuration)
PLC replacement and Custom program changes
Changes to Sterilization Cycles and Lab Test methods among others.
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When validation and when verification
Verification Test
Minor changes not affecting the main operation of the existing EFSP. (Upgrade change parts, upgrade non critical functionalities of the control system, run a product in a different line that already run worst case product, replace sensors, non-operational change in screens like logos, titles names etc…)
Full qualification protocol or SOP protocol is not required. The change affects only one critical parameter, multiple non-critical parameters (verification that the change did not impact normal operation), or feature that test is simple in nature.
Documentation Requirements and Best Testing Practices for Validation and Verification
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When validation and when verification
Verification Test (Cont.)
Addition or changes to instruments that support critical process or critical systems. In this case the verification test should confirm the mechanical and electrical installation, as applicable, calibration record, and functionality test.
Due diligence confirmatory runs to demonstrate that low risk changes have no impact in the validate state of the EFSP and products. (Cleaning a filling line running a new product which is within the existing worst case product family; Running an existing product in a different line that is equivalent to the line that the product is currently filled )
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Interactive Exercise:
Using real life examples, participants will decide what are the best risk tools and why
1. Change in PLC/HMI – move configuration button from main screen to Maintenance Screen (only engineer users have access) and add to the logic change the stack light from green to yellow when the machine is idle.
2. Upgrade Calibration Software to a full version – it will required data migration and additional features will be added.
3. Add a new recipe to a filler line HMI – New bottle configuration.
4. Change coating of rails to minimize scratch in bottles.
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Bonus Material
Impact Assessment Determination and Qualification Requirements Charts
Verification test
Documentation Requirements and Best Testing Practices for Validation and Verification
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Questions and Answers
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Documentation Requirements and Best Testing Practices for Validation and Verification
