目次

How to Establish a Cleaning Validation Program. Introduction. Scope and Approach. Cleaning Validation Team Members and Responsibilities. Cleaning Validation Philosophy. Planning Phase; Analytical Testing and Reporting Phase. Equipment Description. Facility Description. Utilies Description. Utilities Monitoring and Microbiological Controls. Microbiological Cleaning of Equipment Surfaces. Solubility of Active Materials in Water. Toxicity of Active Materials. Cleaning Validation Products Grouping Matrix. Product Equipment Training Matrix. Cleaning Validation Protocols for Fluid Bed Dryer. for Mixer. for Granulation Machines. for Powder Bins. for Sieve. for Encapsulation Machines. for Protocol Pans. Cleaning Validation Protocol for Freeze Dryer. for Glass- Lined Mobile Tank. WHO Good Manufacturing Guidelines for Cleaning Validation.Health Products and Food Branch Inspectorate Guidance Document Cleaning Validation Guidelines. Qualification and Validation. Sampling Tools. Recommended Readings.