Cleaning Validation Manual : A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries

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Author(s):	Haider, Syed Haider, Syed Imtiaz
ISBN No.:	9781439826607
Pages:	608
Year:	201005
Format:	Trade Cloth (Hard Cover)
Price:	$ 262.20
Dispatch delay:	Dispatched between 7 to 15 days
Status:	Available

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Table of contents
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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 Qualifi cation and Validation CLV-43 Sampling Tools CLV-44 Recommended Readings t-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.

4 Qualifi cation and Validation CLV-43 Sampling Tools CLV-44 Recommended ReadingsCleaning 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 Qualifi cation and Validation CLV-43 Sampling Tools CLV-44 Recommended ReadingsFilter 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.

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