Syed Imtiaz Haider and Erfan Syed Asif are with Gulf Pharmaceutical Industries in the United Arab Emirates.

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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.

Syed Imtiaz Haider and Erfan Syed Asif are with Gulf Pharmaceutical Industries in the United Arab Emirates.

Select Guide Rating

• 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.