Cleaning Validation

Practical Compliance Approaches for Pharmaceutical Manufacturing
1. Auflage 2024
ISBN: 978-1-032-43173-4
Verlag: CRC Press

Buch, Englisch, 216 Seiten, Format (B × H): 152 mm x 229 mm, Gewicht: 323 g

Pharmaceutical manufacturers and upper management are encouraged to meet the

challenges 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 a

more 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 particularly

upper management, to meet the challenges of the science-based and riskbased

approaches to cleaning validation.

• Draws on the author’s vast experience in the field of cleaning validation

and hazardous materials.

• Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP for

highly hazardous products in shared facilities.

• A diverse list of topics from protocol limits for yeasts and molds to

cleaning validation for homeopathic drug products.

Zielgruppe

Academic, Postgraduate, Professional Practice & Development, and Undergraduate Advanced

Autoren/Hrsg.

LeBlanc, Destin A.

Fachgebiete

• Naturwissenschaften Chemie Chemie Allgemein
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie

Inhaltsverzeichnis

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 2

Analytical 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 Analogy

Appendix A: Acronyms Used in this Volume

Appendix B: Shorthand Notations for Expressing Limits

Index

Über Autor(innen)

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.