The Challenge of CMC Regulatory Compliance for Biopharmaceuticals by John Geigert

Author:John Geigert
Language: eng
Format: epub, pdf
ISBN: 9783030137540
Publisher: Springer International Publishing

At the commercial level, the biopharmaceutical purification process is subject to GMP compliance inspections from various regulatory authorities. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between regulatory authorities in the field of GMP of medicinal products. PIC/S presently comprises 52 participating authorities coming from all over the world (Europe, Africa, America, Asia and Australasia). The PIC/S group has prepared a questionnaire inspection aid to help inspectors assess whether the biologic purification process is under adequate and appropriate GMP control (see Table 6.5).Table 6.5Some guidance in the PIC/S regulatory aid for GMP inspection of a purification process [38]

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