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microbiological testing
and purity prior to release for production or distribution
There shall be separate or defined areas necessary to prevent contamination or mix-ups during receipt
Compendial methods taken from USP
and expiration dates
8.3 - Laboratory Specifications oot microbiological testingThere must be appropriately authorised and dated specifications for all components, including active materials and excipients, packaging, in process materials, and drug products designed to ensure that each lot number conforms to appropriate standards of identity, strength, quality and purity
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