Process Validation Protocols Equipment Qualification Protocols Protocol Templates Key sections and content Protocol Problems

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1 STRATEGIES TO WRITE EFFECTIVE VALIDATION PROTOCOLS Paul L. Pluta, PhD Journal of Validation Technology Journal of GXP Compliance University of Illinois College of Pharmacy Chicago, IL USA 1 OUTLINE Protocols General PV Guidance requirements Process Validation Protocols Equipment Qualification Protocols Protocol Templates Key sections and content Protocol Problems 2 1

2 OBJECTIVES and APPROACH Review FDA Process Validation Guidance (draft) Specific FDA requirements Consider FDA Guidance requirements in protocol preparation p Consider Corporate requirements / templates Review PQ document group Requirements of PV stages Stage 1, Stage 2, Stage 3 Application to Qualification documents Approval of validation documents Templates for PQ documents provided Protocol problems Participation needed! 3 TERMINOLOGY: PROCESS VALIDATION Process Validation Process Qualification Qualification Qualification Equipment #1 HVAC Utilities Equipment #2 Facilities Computers Equipment #3 Analytical methods validation Cleaning process validation Packaging process validation Application to other process validation 4 2

3 FDA PROCESS VALIDATION GUIDANCE (DRAFT) Definition: Collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products. Three stages of activities: Stage 1 Process Design Development and scale-up activities Stage 2 Process Qualification Reproducible manufacturing Stage 3 Continued Process Verification Routine production This document consistent with GHTF medical device process validation. 5 FDA PROCESS VALIDATION GUIDANCE (DRAFT) Before commercial distribution to consumers, a manufacturer should have gained a high degree of assurance in the manufacturing process Manufacturers should: Understand the sources of variation Detect the presence and degree of variation Understand the impact of variation on the process and product attributes Control the variation in a manner commensurate with risk to process and product 6 3

4 FDA PROCESS VALIDATION GUIDANCE (DRAFT) Good project management and good archiving to capture scientific knowledge. Enhance accessibility of information later in lifecycle. Integrated team approach: Process engineering, industrial pharmacy, analytical chemistry, microbiology, statistics, manufacturing, and quality assurance. 7 PROCESS DESIGN (PROCESS UNDERSTANDING) Define commercial-scale process Define unit operations and process parameters Identify and understand sources of variability Identify critical process parameters Studies to understand effects of scale Establish mechanisms to control variability Process Analytical Technology Designed experiments Lab scale and pilot scale experiments Reference: McNally, Grace. GMP by the Sea, 8-07,

5 PROCESS DESIGN (PROCESS UNDERSTANDING) Objective API and excipient pharmaceutics Quality attributes Risk analysis Process parameters Design of experiments Design space Normal operating range In-process controls Product development key inputs to design stage Variability by different component lots, production operators, environmental conditions, and measurement systems Use risk analysis tools to screen variables Establish a strategy for process control 9 QUALITY BY DESIGN (QbD) 1. Target product profile 2. Critical quality attributes 3. Critical process parameters 4. Design space 5. Input variable control strategy 6. Continuous improvement Other considerations: PAT, Risk analysis 10 5

6 PROCESS QUALIFICATION (VALIDATION PERFORMANCE) Confirmation at commercial scale of process design information Qualification of equipment, utilities, facilities Performance qualification Conclusion that process consistently produces quality product. Conformance batches All support systems, documents, training, personnel, etc. in place Target / nominal operating parameters within design space Additional testing Decision to release process for routine commercial manufacturing Reference: McNally, Grace. GMP by the Sea, 8-07, PROCESS QUALIFICATION Conformance Lots Procedures Validation plans Protocols Sampling Testing Results Plan to maintain validation ALL EQUIPMENT AND SUPPORTING SYSTEMS MUST BE QUALIFIED. 12 6

7 PERFORMANCE QUALIFICATION APPROACH Higher level of sampling, testing, and scrutiny of process performance. Protocol should address: Operating parameters, processing limits, and raw material inputs Data to be collected and how evaluated Test to be performed and acceptance criteria Sampling plan sampling points, number of samples, frequency Statistical methods used Statistical confidence levels Provisions to address deviations and non-conformances Facility, utility, and equipment qualification Personnel training Status of analytical method validation Review and approval by appropriate departments and quality unit NOTE DETAILS FROM PV GUIDANCE 13 PERFORMANCE QUALIFICATION APPROACH The PQ lots should be manufacturer under normal conditions by personnel expected to routinely perform each step of each unit operation in the process. Normal operating conditions should cover the utility systems (air handling and water purification), material, personnel environment, and manufacturing procedures. PQ report: Discuss all aspects of protocol Summarize and analyze data as specified in protocol Evaluate unexpected observations and additional data Summarize and discuss nonconformances Describe corrective actions or changes Clear conclusions Approval by appropriate departments and quality unit NOTE DETAILS FROM PV GUIDANCE 14 7

8 CONTINUED PROCESS VERIFICATION (VALIDATION MAINTENANCE) Activities to assure process remains in validated state Annual Product Review Trend and assess data Study OOS and OOT (Out of Trend) data Timely monitoring of critical operating and performance parameters. Monitor product characteristics, personnel training, materials, facilities, equipment, and SOP changes Establish process history based on ongoing process performance Improve process Improve control to detect and reduce variability Change control; evaluate impact of change and test as necessary Reference: McNally, Grace. GMP by the Sea, CONTINUED PROCESS VERIFICATION Monitoring Statistical process control Trend analysis Change control Continuous improvement Revalidation Management review STATISTICIAN RECOMMENDED BY FDA 16 8

9 CONTINUED PROCESS VERIFICATION ITEMS TO BE REVIEWED Product and process data Relevant process trends Quality of incoming materials or components In-process material Finished products Defect complaints OOS findings Deviations Yield variations Batch records Incoming raw material records Adverse event reports Production operator feedback Operator errors also to measure quality of the training program Above should help identify possible product / process improvements 17 EFFECTIVE PROTOCOLS PROCESS VALIDATION Stage 1: Product Design Development information Identification of CQA and CPP Identification of sources of variation Variation control plan Stage 2: Process Qualification Equipment qualification Analytical method validation Stage 3: Continued Process Verification Post PQ plan APR Change control 18 9

10 PRODUCT DESIGN INFORMATION Technical reports from R&D Pharmaceutics reports Development reports (CQA, CPP impact protocols) Technology transfer / Scale-up reports Identification of sources of variation Variation control plans REPORTS STORED IN VALIDATION AREA OR BE READILY AVAILABLE (within 30 minutes) REPORTS SHOULD BE REVIEWED FOR CONSISTENCY BETWEEN GROUPS REPORTS SHOULD BE REFERENCED IN VALIDATION SPECIFIC VALIDATION PLAN, PQ, AND RESULTS REPORT 19 PROCESS VALDIATION PROTOCOLS (PQ) FDA GUIDLINE RECOMMENDATIONS Higher level of sampling, testing, and scrutiny of process performance. Protocol should address: Operating parameters, processing limits, it and raw material inputs Data to be collected and how evaluated Test to be performed and acceptance criteria Sampling plan sampling points, number of samples, frequency Statistical methods used Statistical confidence levels Provisions to address deviations and non-conformances Facility, utility, and equipment qualification Personnel training Status of analytical method validation Review and approval by appropriate departments and quality unit 20 10

11 VALIDATION PHILOSOPHY Validation is confirmation. Acceptable results are expected. Validation is not Research Final stage of development Optimization i Fine-tuning Debugging 21 PROCESS VALDIATION DOCUMENTS Corporate policy Corporate templates use and supplement with new requirements Validation Master Plan (VMP) Validation Request Validation Plan Validation Protocol(s) Engineering Study Other requirements Validation Results Validation Report

12 PROCESS VALIDATION DOCUMENTS Written for the reader US vs. Europe Objective: Understanding Clarity much more important than brevity Stand-alone document Potential for review in 10+ years Author / Management not available Spelling and grammar correct Need good writers Who writes protocols? Simple sentences Simple words 23 VALIDATION REQUEST Objective of validation Why needed? Why acceptable? See Validation Plan Impact of validation Risk analysis Approach to accomplish Compliance to internal requirements and policies Regulatory impact Other systems or product impacted Procedure changes or other document changes Notifications to affected groups (internal, external, labs) Above applicable to equipment and other qualification 24 12

13 TERMINOLOGY EXAMPLES Validation request: Process validation of Product A System: New product validation Change impact: High impact. New product validation Reason: New product to be manufactured at site Justification: See Validation Plan SIMPLE AND CLEAR 25 TERMINOLOGY EXAMPLES Validation request: Qualification of 150 cu. ft. blender System: New equipment qualification Change impact: High impact. New equipment and new size at site Reason: New equipment to increase manufacturing efficiency and throughput Justification: See Validation Plan SIMPLE AND CLEAR 26 13

14 TERMINOLOGY EXAMPLES Validation request: Change air supply and return ductwork to coincide with Line 1 floor space changes System: HVAC system #3 Change impact: Medium impact. Change to direct product contact support utility Reason: Room configuration change to increase manufacturing efficiency Justification: See Validation Plan SIMPLE AND CLEAR 27 VALIDATION PLAN Introduction Technical information Validation strategy and testing Validation documentation List of required protocols, reports, procedures, etc. References List of reports and scientific references Format development critical need model document 28 14

15 VALIDATION PLAN -- INTRODUCTION INTRODUCTION Overview describing validation / product / process / equipment / etc. Requirements to complete validation Conformance to regulations and internal policy validation will be completed Impact of change to maintain the validated state Impact on regulatory submission Impact of change on procedures, drawings, other documents Notifications to other areas internal and external Notification to test labs and other areas impacted by validation 29 VALIDATION PLAN -- TECHNICAL INFORMATION TECHNICAL INFORMATION Basic product / process / equipment description Formula Process Specifications Include non-technical description information Technical aspects of validation / qualification Reference to technical reports from Design Stage or DQ Total validation approach Experimental studies Past data (retrospective data) Validation i protocols Other work New procedures Number of lots related to impact of change and risk WRITTEN FOR THE READER 30 15

16 VALIDATION PLAN VALIDATION STRATEGY AND TESTING Prospective validation only IQ / OQ / PQ -- general Types of testing -- general Regulatory specifications Internal controls Process tests Tests and rationale general Address changes based on risk analysis Sampling and rationale general Exceed routine QA testing based on impact and risk analysis Data treatment general Statistical data treatment Acceptance criteria general DETAILS OF ABOVE PROVIDED IN PROTOCOLS 31 VALIDATION PLAN VALDIATION DOCUMENTATION Doc # Title Date closed 01 Validation request 02 XXX Dryer Engineering Study 03 XXX Dryer Qualification 04 XXX Process Scale-up Engineering Study 05 XXX Process Validation 06 Update Validation Master Plan Product and Equipment sections 07 XXX Project Summary Report 32 16

17 VALIDATION PLAN -- REFERENCES R&D Reports Published literature Scientific and technical support to validation plan Report copies in validation area 33 VALIDATION PROTOCOL Objective of validation specific protocol Validation description -- specific System description (for equipment) Validation approach Testing and rationale -- specific Sampling and rationale -- specific Data treatment -- specific Acceptance criteria specific All testing must have acceptance criteria Data sheets specific Validation is confirmation 34 17

18 VALIDATION PROTOCOL TESTING AND SAMPLING Based on product specifications and testing Exceed routine QA testing based on impact and risk Consider the following: Product for seizures Product for hypertension New product Change in compressing machine Increase compressing machine speed Change in granulation method Change in batch size 35 VALIDATION PROTOCOL FDA Powder Blends and Finished Dosage Units Stratified Sampling and Assessment Blend sampling. n = 10, Individuals, id RSD Tablets. 20 samples, n = 3-7 per location, mean, range, RSD. Application is possible approach for high risk products Supportive of USP Uniformity of Dosage Units on composite / stratified samples Product types: Potency and weight testing 36 18

19 VALIDATION SAMPLING What is routine QA sampling? Impact of change No impact Low impact Medium impact High impact Risk analysis High risk Regular risk Low risk 37 ENGINEERING STUDY Conducted in advance of validation No acceptance criteria Ti Trial run Examples: Manufacturing process without bulk drug (low dose API) Process runs with placebo Categories of Engineering Studies Conduct Engineering Study concurrently with validation? - - Not recommended 38 19

20 DATA SHEETS Designed sheet with space for expected data Data treatment specified Signature and data of person supplying data Highly recommended for Operators or persons not familiar with sampling Prevents missing data in complex protocols Record sampling and / or testing 39 VALIDATION RESULTS Data sheets Data treatment Results Discussion Results pass is not sufficient. Validation statement: Results indicate that is validated. Post-validation monitoring plan 40 20

21 VALIDATION REPORT Recommended for complex projects Recommended for multiple protocol projects PRIMARY REPORT FOR AUDIT Cut and Paste exercise from multiple documents Best approach to avoid inconsistency 41 VALIDATION REPORT FORMAT Introduction Key information from Validation Plan Supporting information Protocol #1 results Protocol #2 results Protocol #3 results Protocol #n results Project conclusions (for Validation Plan) Validation statement Results indicate that is validated

22 EQUIPMENT QUALIFICATION IQ, OQ, PQ Same approach as with processes Same philosophy Same requirements Same approval Critical tests only Non-critical tests in FAC, SAC, etc. Do as much as possible in commissioning Difference from PV: Do tests only once 43 EQUIPMENT QUALIFICATION IQ Installation Qualification Function: Materials, structure, and maintenance OQ Operational Qualification Function: Operation PQ Performance Qualification Function: Operation with materials and / or within other system components 44 22

23 VALIDATION DOCUMENT APPROVAL Approval group must review documents with perspective p of an external auditor Assure compliance with regulations Assure acceptability of technical validation and product quality Assure acceptability of documentation. Spelling and grammar 45 VALIDATION DOCUMENT APPROVAL Technical validation Scientific and technical principles Consistent approach Supports objective of validation Supports routine manufacturing in type of testing and sampling Support routine manufacturing in duration of sampling and testing Results and discussion support data Correct technical conclusions Equipment testing support entire operating range used in manufacturing 46 23

24 PROTOCOL PROBLEMS No plan No basic explanation of validation No statement of strategy and approach No test rationale No sampling rationale How to treat data No discussion of results No acceptance criteria rationale No validation statement t t Poorly written Written for the reader 47 PROTOCOL PROBLEMS Protocol requires BME samples for potency. Acceptance criteria: % B = 95% M = 100% E = 105% All results pass Conclusion? 48 24

25 PROTOCOL PROBLEMS There is no requirement for 3 lots. Consider impact of change. Consider product. Consider risk. What is post validation plan? How many lots should be done? 49 SUPPORTING DOCUMENTS PROCESS ANALYTICAL TECHNOLOGY (PAT) Processes verified by PAT are not validated All associated PAT equipment and analytical methods are validated Reference: FDA. PAT -- A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. September

26 SUPPORTING DOCUMENTS PROCESS ANALYTICAL TECHNOLOGY (PAT) Process Understanding All critical sources of variability are identified and explained. Variability is managed by the process Product quality attributes can be accurately and reliably predicted over the design space Materials used Process parameters Manufacturing Environmental Other conditions Reference: FDA. PAT -- A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. September 2004 WHEN PAT IS IN PLACE, WILL THERE BE ANY MORE VALIDATION? 51 SUMMARY WHERE WE ARE -- CURRENT PRACTICE R&D Validation Commercialization 52 26

27 SUMMARY -- VALIDATION CURRENT PRACTICE Emphasis on repeatability (3x) One-time effort Documentation important Last step in development Hope we can pass validation Required for product release to market Key regulations: 1987 Process Validation Guidance 1990 s Pharma Inspection Guidelines 1997 Medical Device Quality Systems Manual 53 SUMMARY -- WHERE WE ARE GOING LIFECYCLE APPROACH TO PROCESS VALIDATION Lifecycle approach: Validation is never completed Validation is always ongoing Objectives: Scientific and technical process Demonstrate process works as intended Process must remain in control Reference: McNally, Grace E. GMP by the Sea, 8-07,

28 LIFECYCLE APPROACH TO PROCESS VALIDATION Process Design Studies to establish process Identify critical process parameters Identify sources of variation Consider range of variation possible in processes Process understanding Process Qualification Equipment, facilities, and utilities Confirm commercial process design Validation performance Continuous process verification Monitor, collect information, assess Maintenance, continuous verification, process improvement Change control Validation maintenance The process of process validation. Reference: McNally, Grace E. GMP by the Sea, 8-07, SUMMARY PROCESS VALIDATION HISTORY 1978 CGMP includes Validation 1987 Development -- VALIDATION -- Control 2008 Lifecycle approach Continuum of understanding validation maintenance UNDERSTANDING -- VALIDATION -- MAINTENANCE 56 28

29 SUMMARY VALIDATION -- FUTURE Understanding Performance Maintenance 57 SUMMARY EFFECTIVE PROTOCOLS Protocols consistent with validation guidelines and expectations Validation guidelines specify details Validation is confirmation -- Acceptable results are expected Validation is not R&D, optimization, fine-tuning New requirements Scientific and technical basis CQA and CPP Sources of Variation Variation Control Plan Reference and retrieve R&D reports 58 29

30 SUMMARY Protocol requirements Specific guidance requirements Strategy and approach Impact of change Risk analysis Testing and sampling rationale Acceptance criteria Statistical data treatment Data sheets Post-validation monitoring plan 59 SUMMARY Validation Results Discussion of results Validation statement Summary report for multiple protocol validation or complex products Most important validation document Simple sentences, simple words Written for the reader 60 30

31 REFERENCES -- GENERAL FDA. Guidance for industry. Process Validation: General Principles and Practices. Draft Guidance, November FDA. Guideline of General Principles of Process Validation. May, FDA. Compliance Policy Guide 7132c.08. Section Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market tapproval. GHTF Study Group 3. Quality Management Systems -- Process Validation Guidance. Edition 2, January PQRI. Process Robustness. Pharmaceutical Engineering, Nov-Dec, McNally, Grace E. Lifecycle Approach to Process Validation. DIA Annual Meeting, McNally, Grace E. Insights on Validation. GMP by the Sea, Cambridge, MD McNally, Grace E. Lifecycle Approach Process Validation. GMP by the Sea, Cambridge, MD Famulare, Joseph. Benefits of a Pharmaceutical Quality System. PDA / FDA Joint Conference, Bethesda MD, Health Canada. Validation Guidelines for Pharmaceutical Dosage Forms (GUIDE-0029) REFERENCES PROCESS UNDERSTANDING FDA. Guide to Inspections of Oral Solid Dosage Forms. Pre/Post Approval Issues for Development and Validation FDA. Guide to Inspections of Topical Drug Products FDA. Guide to Inspections. Oral Solutions and Suspensions FDA. PAT -- AF Framework kfor Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance ICH Q7. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients ICH Q8. Pharmaceutical Development PQRI. Process Robustness. Pharmaceutical Engineering, Pharmaceutical Process Validation, 3 rd edition. Drugs and the Pharmaceutical Sciences, Volume 129. Marcel Dekker, New York, NY,

32 REFERENCES PROCESS UNDERSTANDING Product Quality Lifecycle Implementation (PQLI). Draft PQLI Summary Report update, Conformia. Pharmaceutical development Case Study: ACE Tablets, V 2.0. Conformia CMC-IM Working Group, Am Ende, Dave, et.al. API Quality by Design Example from the Torcetrapib Manufacturing Process. J. Pharmaceutical Innovation 2, 71-86, Stryczek, Karel, et.al. Capitalizing on Aggregate Data for Gaining Process Understanding -- Effect of Raw Material, Environmental and dprocess Conditions on the dissolution Rate of a Sustained Release Product. J. Pharmaceutical Innovation 2, 6-17, Somma, Russ. Development Knowledge Can Increase Manufacturing Flexibility and Facilitate Quality by Design. J. Pharmaceutical Innovation 2, 87-92, REFERENCES PROCESS UNDERSTANDING MacGregor, John F. et.al. A Framework for the Development of Design and Control Space. J. Pharmaceutical Innovation 3, 15-22, Cogdill, Robert P. et.al. Risk-based Quality by Design (QbD): A Taguchi Perspective on the Assessment of Product Quality, and the Quantitative Linkage of Drug Process Parameters and Clinical Performance. J. Pharmaceutical Innovation 3, 23-29, 29, Garcia, Thomas, et. al. PQLI Key Topics Criticality, Design Space, and Control Strategy. J. Pharmaceutical Innovation 3, 60-68, Nosal, Roger, et al. PQLI Definition of Criticality. J. Pharmaceutical Innovation 3, 69-78, Lepore, John, et.al. PQLI Design Space J. Pharmaceutical Innovation 3, 79-87, Bolton, Ray, et.al. PQLI Engineering Controls and Automation Strategy. J. Pharmaceutical Innovation 3, 88-94, Davis, Bruce, et.al. PQLI Control Strategy Models and Concepts. J. Pharmaceutical Innovation 3, , Seibert, Kevin D. et.al. The Use of Routine Process Capability for the Deteriation of Process Parameter Criticality in Small-molecle SPI Synthesis. J. Pharmaceutical Innovation 3, ,

33 REFERENCES VALIDATION PERFORMANCE FDA. Guideline of General Principles of Process Validation FDA. Medical Device Quality Systems Manual FDA. Guide to Inspections of Oral Solid Dosage Forms. Pre/Post Approval Issues for Development and Validation FDA. Guide to Inspections of Topical Drug Products. July FDA. Guide to Inspections. Oral Solutions and Suspensions GHTF Study Group 3. Quality Management Systems -- Process Validation Guidance, Edition ASTM E Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment REFERENCES VALIDATION MAINTENANCE FDA. Quality Systems Approach to Pharmaceutical CGMP Regulations. September FDA. Pharmaceutical cgmps for the 21st Century -- A Risk-Based Approach ICH Q10. Pharmaceutical Quality System GHTF Study Group 3. Quality Management Systems -- Process Validation Guidance, Edition Joneckis, Chris, PhD. Implementing Quality Systems. GMP by the Sea, Cambridge, MD

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