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El. knyga: Cleaning Validation: Practical Compliance Approaches for Pharmaceutical Manufacturing [Taylor & Francis e-book]

  • Formatas: 204 pages, 4 Tables, black and white
  • Išleidimo metai: 23-Dec-2022
  • Leidėjas: CRC Press
  • ISBN-13: 9781003366003
Kitos knygos pagal šią temą:
  • Taylor & Francis e-book
  • Kaina: 96,94 €*
  • * this price gives unlimited concurrent access for unlimited time
  • Standartinė kaina: 138,48 €
  • Sutaupote 30%
Cleaning Validation: Practical Compliance Approaches for Pharmaceutical ManufacturingDidesnis paveikslėlis
  • Formatas: 204 pages, 4 Tables, black and white
  • Išleidimo metai: 23-Dec-2022
  • Leidėjas: CRC Press
  • ISBN-13: 9781003366003
Kitos knygos pagal šią temą:
Taylor & Francis e-booksMore info about Taylor & Francis e-books
Partnerių interneto svetainė: https://www.taylorfrancis.com/books/9781003366003
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 authors 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.
Preface ix
About the Author xi
Section I Terminology
Chapter 1 Use of the Term "Product"
3(4)
Chapter 2 Use of the Terms Grouping and Matrixing
7(4)
Chapter 3 Deviations and Nonconformances
11(4)
Chapter 4 Clarifying Terms: Blanks vs. Controls
15(4)
Chapter 5 Meaning of "Dedicated"?
19(4)
Chapter 6 Words (Again?)
23(6)
Section II Health-Based Limits
Chapter 7 What's at Stake with HBELs
29(6)
Chapter 8 A Look at the Revised Risk-MaPP
35(4)
Chapter 9 EMA's Q&A Clarification: Part 1
39(4)
Chapter 10 EMA's Q&A Clarification: Part 2
43(4)
Chapter 11 The EMA Q&A "Clarification" on Limits
47(4)
Chapter 12 The EMA Q&A on Routine Analytical Testing
51(4)
Chapter 13 Other Issues in EMA's Q&A
55(2)
Chapter 14 Highly Hazardous Products in Shared Facilities
57(6)
Section III Limits: General
Chapter 15 EMA vs. ISPE on Cleaning Limits?
63(4)
Chapter 16 Does a High "Margin of Safety" Protect Patients?
67(4)
Chapter 17 What If the Next Product Is the Same Product?
71(4)
Chapter 18 Limits for "Product A to Product A"
75(4)
Chapter 19 Surfaces Areas in Carryover Calculations
79(2)
Chapter 20 Carryover Calculation Errors to Avoid
81(4)
Chapter 21 Protocol Limits for Yeasts/Molds?
85(2)
Chapter 22 Cleaning Validation for Homeopathic Drug Products
87(2)
Chapter 23 A Possible Approach for Biotech Limits
89(4)
Chapter 24 Establishing Clearance for Degraded Protein Actives
93(6)
Section IV Visually Clean
Chapter 25 Avoiding "Visually Dirty" Observations
99(4)
Chapter 26 What's a Visual Limit?
103(4)
Chapter 27 Visual Residue Limits: Part 1
107(4)
Chapter 28 Visual Residue Limits: Part 2
111(6)
Section V Analytical and Sampling Methods
Chapter 29 Two More Nails in the Coffin?
117(4)
Chapter 30 Timing for Swab Sampling in a Protocol?
121(2)
Chapter 31 More Swab Sampling Issues
123(4)
Chapter 32 Pass/Fail Analytical Test Methods
127(6)
Section VI Product Grouping
Chapter 33 Issues in Product Grouping
133(4)
Chapter 34 Toxicity as a Worst-Case Grouping Factor
137(2)
Chapter 35 Another "Worst Case" Product Grouping Idea
139(6)
Section VII Protocols and Procedures
Chapter 36 Issues in Rinsing: Part 1
145(4)
Chapter 37 Issues in Rinsing: Part 2
149(4)
Chapter 38 Routine Monitoring for Highly Hazardous Products
153(4)
Chapter 39 "Concurrent Release" for Cleaning Validation
157(4)
Chapter 40 Dirty and Clean Hold Time Protocols
161(4)
Section VIII API Manufacture
Chapter 41 A Critique of the APIC Guideline
165(6)
Chapter 42 Another Issue for API Synthesis
171(4)
Chapter 43 Contaminants in API Manufacture
175(4)
Section IX Miscellaneous Topics
Chapter 44 Significant Figures: Back to Basics
179(4)
Chapter 45 The Value of a Protocol Worksheet for Manual Cleaning
183(4)
Chapter 46 Dealing with Used and New Equipment
187(4)
Chapter 47 Solving Cleaning Validation Problems by Analogy
191(4)
Chapter 48 Causing Cleaning Validation Problems by Analogy
195(4)
Appendix A 199(2)
Appendix B 201(2)
Index 203
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.
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