8.3 - Laboratory Specifications oot Microbiological pharmacopeia methods are considered

Microbiological pharmacopeia methods are considered to have been validated however the performance criteria and the suitability for each product type must be verified

or contact surfaces could occur

Compendial methods taken from USP

Protective apparel

and expiration dates

8.3 - Laboratory Specifications oot Microbiological pharmacopeia methods are consideredThere 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