10.2 - Outsourced GMP Activities batch disposition maintenance

maintenance

You must identify and hold cleaning and sanitizing agents in a manner that protects against contamination of components

You must use adequate laboratory facilities to perform whatever testing and examinations are necessary to determine whether components

then stored without mix-up or contamination

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

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