Cleaning Validation Manual

A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries

Syed Imtiaz Haider

• Editorial: CRC Press
• Año: 2010
• ISBN:
  9781439826614
• Edición: 1
• Categoría: Medicine
• Categoría: Pharmacology

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.

Índice

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