10.2 - Outsourced GMP Activities batch disposition EP or equivalent

EP or equivalent

Procedures shall be used to reconcile the quantities of labeling issued

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

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10.2 - Outsourced GMP Activities batch disposition EP or equivalentAny 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