10.2 - Outsourced GMP Activities batch disposition maintenance

maintenance

Distribution records shall contain the name and strength of the product and description of the dosage form

supply chain complexity and the final use

The requirements and controls of the QC micro lab to perform microbiological testing of non-sterile products to USP and EP harmonized methods without erroneously  contaminating the growth media by untrained personnel

Procedures shall be used to reconcile the quantities of labeling issued

10.2 - Outsourced GMP Activities batch disposition maintenanceAny outsourced activity covered by Good Manufacturing Practice or Good Distribution Practice guidelines must be approved by the Quality Control unit. The outsourced activity must be appropriately defined, agreed and controlled in order to avoid misunderstandings which could result in a product or operation of unsatisfactory quality