Transcription
Best practices for ProcessValidationMark Durivage, ASQ Fellow, CBA, RAC, CTBSManaging Principal ConsultantQuality Systems Compliance LLCMay 31-June 1, 2017ASQ Biomedical Division1
Define Validation Discuss Validation Requirements Define Risk Discuss Validation Pre-Requisites Discuss the Validation Life Cycle Discuss Common Validation IssuesMay 31-June 1, 2017ASQ Biomedical Division2
“Validations are akin to scientific investigations inwhich the hypotheses are formulated, experiments aredesigned and conducted, data are collected andanalyzed, and conclusions are reached.And like scientific discoveries, validations must bequestioned and retested for the life of the process theycover.”D.M CarlbergCarlberg, D.M., 2005, Cleanroom Microbiology for the Non-Microbiologist 2nd Ed., CRC Press, New York.May 31-June 1, 2017ASQ Biomedical Division3
Validation RequirementsThe importance of validating readily apparent in FDAregulations, ISO standards, and GHTF guidancedocumentsMay 31-June 1, 2017ASQ Biomedical Division4
May 31-June 1, 2017ASQ Biomedical Division5
Definitions "Establish" means define, document(in writing or electronically), andimplement “can” indicates a possibility or acapability “should” indicates a recommendation “shall” indicates a requirement “may” indicates a permission
Validation Activities Commissioning Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Process Performance Qualification (PPQ)May 31-June 1, 2017ASQ Biomedical Division7
QSR Requirements820.75 Process Validation"Where the results of a process cannotbe fully verified by subsequentinspection and test, the process shall bevalidated with a high degree ofassurance and approved according toestablished procedures"May 31-June 1, 2017ASQ Biomedical Division8
QSR Requirements820.250 Statistical Techniques"Where appropriate, each manufacturer shall establish and maintainprocedures for identifying valid statistical techniques required forestablishing, controlling, and verifying the acceptability of processcapability and product characteristics.Sampling plans, when used, shall be written and based on a validstatistical rationale"May 31-June 1, 2017ASQ Biomedical Division9
QSR Requirements820.70 Production andProcess Controls"Each manufacturer shalldevelop, conduct, control, andmonitor production processesto ensure that a deviceconforms to its specifications"May 31-June 1, 2017ASQ Biomedical Division10
Guidance DocumentsGHTF - Quality Management Systems - Process Validation GuidanceFDA - Process Validation: General Principles and PracticesFDA - General Principles of Software ents/ucm085281.htmMay 31-June 1, 2017ASQ Biomedical Division11
GHTF Process Validation Decision TreeAdapted from GHTF Study Group 3Quality Management Systems Process Validation GuidanceJanuary 2004May 31-June 1, 2017ASQ Biomedical Division12
Process and System ValidationInputsMay 31-June 1, 2017ValueAddASQ Biomedical DivisionOutputs13
May 31-June 1, 2017ASQ Biomedical Division14
ValidationPrerequisitesASQ Biomedical DivisionMay 31-June 1, 201715
The ProcessValidationLife CycleMay 31-June 1, 2017Source: Durivage, M.A. and Mehta B., 2016, Practical Process Validation, Milwaukee,ASQ Quality PressASQ Biomedical Division16
Retrospective and Re-Validation ActivitiesMay 31-June 1, 2017ASQ Biomedical Division17
Retrospective ValidationMay 31-June 1, 2017ASQ Biomedical Division18
Re-ValidationActivitiesMay 31-June 1, 2017ASQ Biomedical Division19
FDA Warning Letters Summary (Validation) Missing rationale for the comparison of data from old and new PQ runs Failure "maintaining the process in state of control" Missing "root cause analysis" as required in the validation planfor evaluating inadequate results Missing rationale for the number of PQ runs Arbitrary sampling planSource: http://www.gmp-compliance.org/eca news 2025 6374,6246,6247,6418.htmlMay 31-June 1, 2017ASQ Biomedical Division20
Common Validation IssuesMay 31-June 1, 2017ASQ Biomedical Division21
May 31-June 1, 2017ASQ Biomedical Division22
Use a Risk-Based Statistical Rationale Keep Apprised of Current Industry Trends Under Promise – Over Deliver on ValidationCommitments Perform Continuous Process Monitoring Document Your Plan, Actions, and ResultsMay 31-June 1, 2017ASQ Biomedical Division23
Questions
May 31-June 1, 2017ASQ Biomedical Division25
Contact .comhttps://www.linkedin.com/in/markdurivageMay 31-June 1, 2017ASQ Biomedical Division26
ASQ Quality Press. Retrospective and Re-Validation Activities May 31-June 1, 2017 ASQ Biomedical Division 17. Retrospective Validation May 31-June 1, 2017 ASQ Biomedical Division 18. Re-Validation Activities May 31-June 1, 2017 ASQ Biomedi
