Requirement for GMP audit of  API manufacturer by MAH

The implementation of EU directives 2004/27/EC and 2004/28/EC makes the requirement for marketing authorisation holder (MAH) to ensure that their Active Pharmaceutical Ingredients (API) have been manufactured to GMP. 

These directives require that API manufacturers follow GMP and provide powers of inspection to the EU inspectorates. EMEA guidelines ref. EMEA/INS/GMP/50288/2005 also makes the following statement:

“… Examination, by inspectors, of the audit programmers used by authorization holders for conducting regular audits (every 2-3 years), including review of audit reports, is one of the primary means by which Competent Authorities will determine if manufacturing authorization holders are in compliance with the above articles.”

In addition EU Manufacturers Authorization holders (including dosage form manufacturers or wholesale importers from outside Europe) are increasingly being called upon to make declarations of GMP of the API source(s) in EU Marketing Authorization Applications and variations. This declaration often falls within the responsibilities of the QP/QA personnel.

One of the most reliable ways of gaining this assurance in the short-term will be via audits.

• Contract Manufacturing Strategies (10/06/2008)
• Biomanufacturing Strategies (13/05/2008)
• Ceftazidime Injectable (16/04/2008)

• CRO Services (17/08/2006)
• Biogenerics (17/03/2006)
• DMF project (03/01/2006)
• Data Exclusivity (29/12/2005)
• New CADREAC (16/12/2005)

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