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.