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Grouping Products & Equipment for Cleaning Validation & Selection of Worst-Case Parameters
This week, Stacey is joined once again by Rich Forsyth. Stacey and Rich discuss some strategies for simplifying the cleaning validation activities and achieving efficiencies throughout the process.
Richard Forsyth, Principal Consultant Forsyth Pharmaceutical Consulting Rich is responsible for customer support for Cleaning Validation and Cleaning related topics. He has worked as a consultant for several years and prior to that worked in as Associate Director with Merck & Co. for more than three decades. He has been involved with Cleaning Validation for over 20 years. Rich has a broad range of analytical experience including methods development and validation as well as formulation development and project management. Academic training includes an MS in Chemistry and an MBA in Management, both from St. Joseph’s University in Philadelphia, PA.
Links:
FDA Cleaning Validation Guideline from CFR 211.67 - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.67
FDA CFR 211 - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211
FDA Questions & Answers on Current Good Manufacturing Practices—Equipment - https://www.fda.gov/drugs/guidances-drugs/questions-and-answers-current-good-manufacturing-practices-equipment
EMA Cleaning Guidance - https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-setting-health-based-exposure-limits-use-risk-identification-manufacture-different_en.pdf
EMA Cleaning Validation Guideline on setting HBELs - https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-setting-health-based-exposure-limits-use-risk-identification-manufacture-different_en.pdf
QnA on the implementation of the above guideline
EMA - https://www.ema.europa.eu/en/documents/other/questions-answers-implementation-risk-based-prevention-cross-contamination-production-guideline_en.pdf
ISPE Cleaning Validation Guide - https://ispe.org/publications/guidance-documents/guide-cleaning-validation-lifecycle-applications-methods-controls
WHO Cleaning Guidance - https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS20_849_Rev.1_points_to_consider_hbels_in_cleaning_validation.pdf?ua=1
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
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By IVT NetworkThis week, Stacey is joined once again by Rich Forsyth. Stacey and Rich discuss some strategies for simplifying the cleaning validation activities and achieving efficiencies throughout the process.
Richard Forsyth, Principal Consultant Forsyth Pharmaceutical Consulting Rich is responsible for customer support for Cleaning Validation and Cleaning related topics. He has worked as a consultant for several years and prior to that worked in as Associate Director with Merck & Co. for more than three decades. He has been involved with Cleaning Validation for over 20 years. Rich has a broad range of analytical experience including methods development and validation as well as formulation development and project management. Academic training includes an MS in Chemistry and an MBA in Management, both from St. Joseph’s University in Philadelphia, PA.
Links:
FDA Cleaning Validation Guideline from CFR 211.67 - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.67
FDA CFR 211 - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211
FDA Questions & Answers on Current Good Manufacturing Practices—Equipment - https://www.fda.gov/drugs/guidances-drugs/questions-and-answers-current-good-manufacturing-practices-equipment
EMA Cleaning Guidance - https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-setting-health-based-exposure-limits-use-risk-identification-manufacture-different_en.pdf
EMA Cleaning Validation Guideline on setting HBELs - https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-setting-health-based-exposure-limits-use-risk-identification-manufacture-different_en.pdf
QnA on the implementation of the above guideline
EMA - https://www.ema.europa.eu/en/documents/other/questions-answers-implementation-risk-based-prevention-cross-contamination-production-guideline_en.pdf
ISPE Cleaning Validation Guide - https://ispe.org/publications/guidance-documents/guide-cleaning-validation-lifecycle-applications-methods-controls
WHO Cleaning Guidance - https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS20_849_Rev.1_points_to_consider_hbels_in_cleaning_validation.pdf?ua=1
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.