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You must maintain your physical plant in a clean and sanitary condition using cleaning compounds and sanitizing agents that are free from microorganisms of public health significance and that are safe and adequate under the conditions of use
Developmental stability
EP or other recognised test methods
Methods requiring validation must be added to the VMP
6.0 - Production Overview batch record You must maintain your physicalThere shall be written procedures for production and process control designed to assure that the drug products have the correct identity, strength, quality, and purity. These must be followed and documented at the time of performance. Any deviation from the written procedures shall be recorded and justified
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