954, Reliance on the certificate of So it may be acceptable not to test 1169 analysis (…) samples of incoming materials? 1932 1030 The initial processing steps of the This is a grey area where GMP and starting materials (e.g. isolation, tissue bank authorities are sometimes purification) are manufacturing contradicting, eg regarding the activities that should be conducted of the Clinimacs equipment. in accordance with the Please clarify. manufacturing requirements for pharmaceuticals, even if it is done by a third party (e.g. a tissue establishment).
954, 1169 1932 Reliance on the certificate of analysis (…) So it may be acceptable not to test samples of incoming materials? 1030 The initial processing steps of the starting materials (e.g. isolation, purification) are manufacturing activities that should be conducted in accordance with the manufacturing requirements for pharmaceuticals, even if it is done by a third party (e.g. a tissue establishment). This is a grey area where GMP and tissue bank authorities are sometimes contradicting, eg regarding the of the Clinimacs equipment. Please clarify.
uza_ccrg.docx