8.3 - Laboratory Specifications oot including effective and reproducible cleaning

including effective and reproducible cleaning processes to control risk of cross-contamination

and purity prior to release for production or distribution

or holding of a drug product shall have education

For wholesale distribution of drug products in Europe

There shall be separate or defined areas necessary to prevent contamination or mix-ups during receipt

8.3 - Laboratory Specifications oot including effective and reproducible cleaningThere 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