The equipment used in pharmaceutical manufacturing has advanced and improved significantly during the last few decades. Furthermore, although there are books, articles, support manuals, and internet resources on cleaning principles and related processing methods, none of them offer a single database with easily accessible, usable training materials. So far. How to teach the workforce engaged in the development, manufacture, auditing, and validation of biopharmaceuticals on a pilot scale in order to scale up production is explained in Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries.
This book offers technological solutions to help meet the training needs of completed pharmaceutical manufacturers by providing more than 20 simple template methods for cleaning validation of heavily utilized equipment. The book provides practical instruction based on contemporary methods and strategies, drawing on the writers' more than 20 years of experience in the biotech and pharmaceutical sectors. The book offers ready-to-use formulas for creating Master Plans, SOPs, and validation protocols rather than just guidelines or thought processes. Using a pharmaceutical manufacturing site with both sterile and non-sterile operations as the case facility, it covers cleaning protocols for the most often used equipment in different manufacturing regions and associated sampling sites. 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.
Table of Content
CLV-1 How to Establish a Cleaning Validation Program
CLV-2 Introduction
CLV-3 Scope and Approach
CLV-4 Cleaning Validation Team Members and 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/Detergent Description
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-Lined Mobile 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 for Biological 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 Qualificationand Validation
CLV-43 Sampling Tools
CLV-44 Recommended Readings
Biography
Syed Imtiaz Haider and Erfan Syed Asif are with Gulf Pharmaceutical Industries in the United Arab Emirates.
Syed Imtiaz Haider is a long-standing professional in the biopharmaceutical industry, largely based in the United Arab Emirates. He has over 25 years in direct line supervision in all quality control aspects of biopharmaceuticals. He is currently the chief scientist at the Gulf Pharmaceutical Industries in Saudi Arabia. Dr. Haider has published 7 books in related technologies and published over 150 papers in biopharmaceutical research and development.
Download Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries from the link below.
ALSO READ: Master Cleaning Validation Plan
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