Cleaning Validation Manual
eBook - PDF

Cleaning Validation Manual

A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries

Syed Imtiaz Haider

  1. 608 pages
  2. English
  3. PDF
  4. Disponible sur iOS et Android
eBook - PDF

Cleaning Validation Manual

A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries

Syed Imtiaz Haider

DĂ©tails du livre
Table des matiĂšres
Citations

À propos de ce livre

During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-use training tools. Until now. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries elucidates how to train the man power involved in development, manufacturing, auditing, and validation of bio pharmaceuticals on a pilot scale, leading to scale-up production.

With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors' more than two decades of experience in the pharmaceutical and biotech industries, the text offers hands-on training based on current approaches and techniques. The book does not merely provide guidelines or thought processes, rather it gives ready-to-use formulas to develop Master Plan, SOPs, and validation protocols. It includes cleaning procedures for the most commonly used equipment in various manufacturing areas and their sampling points, using a pharmaceutical manufacturing site with both sterile and non-sterile operations as the case facility. It also provides the training guidelines on downloadable resources to enable users to amend or adopt them as necessary.

Grounded in practicality, the book's applicability and accessibility set it apart. It can be used as a guide for implementing a cleaning validation program on site without the help of external consultants, making it a resource that will not be found collecting dust on a shelf, but rather, referred to again and again.

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Informations

Éditeur
CRC Press
Année
2010
ISBN
9781439826614
Édition
1
Sujet
Medicine
Sous-sujet
Pharmacology

Table des matiĂšres

  1. Front cover
  2. Contents
  3. List of Figures
  4. List of Tables
  5. About the Book
  6. Preface
  7. Acknowledgments
  8. Authors
  9. Introduction
  10. Disclaimer
  11. CLV-1: How to Establish a Cleaning Validation Program
  12. CLV-2: Introduction
  13. CLV-3: Scope and Approach
  14. CLV-4: Cleaning Validation Team Membersand Responsibilities
  15. CLV-5: Cleaning Validation Philosophy, Strategies,and Methodology
  16. CLV-6: Planning Phase
  17. CLV-7: Execution Phase
  18. CLV-8: Analytical Testing and Reporting Phase
  19. CLV-9: Equipment Description
  20. CLV-10: Facility Description
  21. CLV-11: Utilities Description: DIW, WFI, Steam,and Compressed Air
  22. CLV-12: Utilities Monitoring and Microbiological Control
  23. CLV-13: Equipment Cleaning Materials/DetergentDescription
  24. CLV-14: Microbiological Cleaning of Equipment Surface
  25. CLV-15: Solubility of Active Materials in Water
  26. CLV-16: Toxicity of Active Materials
  27. CLV-17: Cleaning Validation Products Grouping Matrix (Tablets, Capsules, and PPS)
  28. CLV-18: Product/Equipment Train Matrix (Tab–Cap–PPS)
  29. CLV-19: Worst-Case Products (Tablets, Capsules,and PPS) Matrix
  30. CLV-20: Validation with Corresponding Cleaning Procedures
  31. CLV-20.1: Cleaning Validation Protocol for Fluid Bed Dryer
  32. CLV-20.2: Cleaning Validation Protocol for Mixer
  33. CLV-20.3: Cleaning Validation Protocol for Granulation Machines (Type A)
  34. CLV-20.4: Cleaning Validation Protocol for Powder Bins
  35. CLV-20.5: Cleaning Validation Protocol for Tablet Press
  36. CLV-20.6: Cleaning Validation Protocol for Sieve
  37. CLV-20.7: Cleaning Validation Protocol for Powder-Filling Machine
  38. CLV-20.8: Cleaning Validation Protocol for Encapsulation Machine
  39. CLV-20.9: Cleaning Validation Protocol for Film-Coating Pan
  40. CLV-20.10: Cleaning Validation Protocol for Sugar-Coating Pan
  41. CLV-21: Cleaning Validation Product Grouping Matrix (Syrup)
  42. CLV-22: Cleaning Validation Product/Equipment Train (Syrup)
  43. CLV-23: Worst-Case Products (Syrup
  44. CLV-24: Cleaning Validation Product Grouping Matrix (Suspension)
  45. CLV-25: Product Grouping/Equipment Train Matrix (Suspension)
  46. CLV-26: Worst-Case Products (Suspension)
  47. CLV-27: Product Grouping Matrix (Drops)
  48. CLV-28: Product/Equipment Train (Drops)
  49. CLV-29: Worst-Case Products (Drops)
  50. CLV-30: Cleaning Validation Product Grouping Matrix (Cream/Ointment)
  51. CLV-31: Product/Equipment Train (Cream and Ointment)
  52. CLV-32: Worst-Case Products (Ointment and Cream)
  53. CLV-33: Product Grouping Matrix (Suppositories)
  54. CLV-34: Cleaning Validation Product/Equipment Train (Suppositories)
  55. CLV-35: Worst-Case Products (Suppositories)
  56. CLV-36: Cleaning Validation Protocols Products (Suppositories)
  57. CLV-36.1 Protocol for Manufacturing Vessel
  58. CLV-36.2 Protocol for Bin-Washing Station
  59. CLV-36.3 Cleaning Validation Protocol for Syrup-Holding Tank
  60. CLV-36.4: Protocol for Filling Station and Filter Assembly
  61. CLV-37: Cleaning Validation Product Grouping Matrix (Sterile)
  62. CLV-38 Cleaning Validation Product/Equipment Train Matrix (Sterile)
  63. CLV-39 Validation Protocols Biological and Sterile Products
  64. CLV-39.1 Cleaning Validation Protocol for Freeze Dryer
  65. CLV-39.2 Cleaning Validation Protocol for Glass-LinedMobile Tank
  66. CLV-39.3 Protocol for Preparation and Holding Vessel for Egg Protein
  67. CLV-39.4 Protocol for Filtration Assembly
  68. CLV-39.5 Protocol for Preparation and Holding Vessels forBiological Products
  69. CLV-39.6 Protocol for Filtration Assembly and Filling Machine for Biological Products
  70. CLV-40 Cleaning Validation Tentative Plan (Schedule)
  71. CLV-41 Cleaning Validation Sampling and Testing Status
  72. CLV-42 Cleaning Validation Regulatory Guidelines
  73. CLV-42.1 Guide to Inspections Validation of Cleaning Processes
  74. CLV-42.2 WHO Good Manufacturing Guidelines for Cleaning Validation
  75. CLV-42.3 Health Products and Food Branch Inspectorate Guidance Document Cleaning Validation Guidelines GUIDE-0028
  76. CLV-42.4 Qualification and Validation
  77. CLV-43 Sampling Tools
  78. CLV-44 Recommended Readings
  79. Index
  80. Body
  81. Back cover
Normes de citation pour Cleaning Validation Manual

APA 6 Citation

Haider, S. I. (2010). Cleaning Validation Manual (1st ed.). CRC Press. Retrieved from https://www.perlego.com/book/1601648/cleaning-validation-manual-a-comprehensive-guide-for-the-pharmaceutical-and-biotechnology-industries-pdf (Original work published 2010)

Chicago Citation

Haider, Syed Imtiaz. (2010) 2010. Cleaning Validation Manual. 1st ed. CRC Press. https://www.perlego.com/book/1601648/cleaning-validation-manual-a-comprehensive-guide-for-the-pharmaceutical-and-biotechnology-industries-pdf.

Harvard Citation

Haider, S. I. (2010) Cleaning Validation Manual. 1st edn. CRC Press. Available at: https://www.perlego.com/book/1601648/cleaning-validation-manual-a-comprehensive-guide-for-the-pharmaceutical-and-biotechnology-industries-pdf (Accessed: 14 October 2022).

MLA 7 Citation

Haider, Syed Imtiaz. Cleaning Validation Manual. 1st ed. CRC Press, 2010. Web. 14 Oct. 2022.