Cleaning Validation

Practical Compliance Approaches for Pharmaceutical Manufacturing

Häftad, Engelska, 2024

Av Destin A. LeBlanc, Destin a. LeBlanc, Destin A. Leblanc

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Pharmaceutical manufacturers and upper management are encouraged to meet thechallenges of the science-based and risk-based approaches to cleaning validation.Using some of the principles and practices in this volume will help in designing amore effective and efficient cleaning validation program.Features• Timely coverage of cleaning validation for the pharmaceutical industry,a dynamic area in terms of health-based limits.• The author encourages pharmaceutical manufacturers, and particularlyupper management, to meet the challenges of the science-based and riskbasedapproaches to cleaning validation.• Draws on the author’s vast experience in the field of cleaning validationand hazardous materials.• Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP forhighly hazardous products in shared facilities.• A diverse list of topics from protocol limits for yeasts and molds tocleaning validation for homeopathic drug products.

Produktinformation

Utgivningsdatum2024-10-09
Mått152 x 229 x 12 mm
Vikt400 g
FormatHäftad
SpråkEngelska
Antal sidor204
FörlagTaylor & Francis Ltd
ISBN9781032431734

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Destin LeBlanc is a consultant at Cleaning Validation Technologies. He has extensive experience in product development and technical services for cleaning and antimicrobial applications. He is an international lecturer on contamination control and has written widely on cleaning validation topics including four volumes in the "Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing" series published by PDA and DHI. He is a member of PDA and ISPE and has trained FDA personnel on cleaning validation. He is a graduate of the University of Michigan and the University of Iowa.

Terminology Use of the Term "Product" Use of the Terms Grouping and Matrixing Deviations and Nonconformances Clarifying Terms: Blanks vs. Controls Meaning of "Dedicated"? Words (Again??) Health-based Limits What's at Stake with HBELs A Look at the Revised Risk-MaPP EMA's Q&A Clarification: Part 1 EMA's Q&A Clarification: Part 2 The EMA Q&A "Clarification" on Limits The EMA Q&A on Routine Analytical Testing Other Issues in EMA's Q&A Highly Hazardous Products in Shared Facilities Limits - General EMA vs. ISPE on Cleaning Limits? Does a High "Margin of Safety" Protect Patients? What If the Next Product is the Same Product? Limits for "Product A to Product A" Surfaces Areas in Carryover Calculations Carryover Calculation Errors to Avoid Protocol Limits for Yeasts/Molds? Cleaning Validation for Homeopathic Drug Products A Possible Approach for Biotech Limits Establishing Clearance for Degraded Protein Actives Visually Clean Avoiding "Visually Dirty" Observations What's a Visual Limit? Visual Residue Limits – Part 1 Visual Residue Limits – Part 2Analytical and Sampling Methods Two More Nails in the Coffin? More Swab Sampling Issues Timing for Swab Sampling in a Protocol? Pass/Fail Analytical Test Methods Product Grouping Issues in Product Grouping Toxicity as a Worst-Case Grouping Factor Another "Worst Case" Product Grouping Idea Protocols and Procedures Issues in Rinsing - Part 1 Issues in Rinsing - Part 2 Routine Monitoring for Highly Hazardous Products "Concurrent Release" for Cleaning Validation Dirty and Clean Hold Time Protocols API Manufacture A Critique of the APIC Guideline Another Issue for API Synthesis Contaminants in API Manufacture Miscellaneous Significant Figures: Back to Basics The Value of a Protocol Worksheet for Manual Cleaning Dealing with Used and New Equipment Solving Cleaning Validation Problems by Analogy Causing Cleaning Validation Problems by AnalogyAppendix A: Acronyms Used in this VolumeAppendix B: Shorthand Notations for Expressing LimitsIndex