10.2 - Outsourced GMP Activities batch disposition You must identify and hold

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

EP or equivalent

then stored without mix-up or contamination

10.2 - Outsourced GMP Activities batch disposition You must identify and holdAny 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