To identify the still existing gaps and deficiencies with view to international (EU / US/JAPAN) GMP-compliance standards. In addition, to help to prepare for the important inspections performed by the individual authorities (e.g. FDA/MHRA/EDQM/PMDA/MCC) or customers. In this case the audit is done as a mock inspection. Further on to prepare for customer audits and to help to find the way to the European , Japanese ,US and rest of the world market place.
We conduct GMP audits/inspections to verify the compliance status of the manufacturer and suggest improvements. The types of audits that are covered here include gap analysis audits and mock inspections to assess the preparedness level for GMP inspections. This also supplements the internal self-inspection and expectations of the regulatory agencies of an independent audit of QA department by external agency
||3. Audits for Quality System Compliance for the following manufactures:
FACILITIES AUDITED / GAP ANALYSIS UNDERTAKEN:
Titan Laboratories, Anuh Pharma Limited, Cadila Healthcare Limited, Suchem Laboratories,
Prerequisites: Basic GMP system should be implemented and work