MHRA statement on 3rd party audits

Regulatory Requirements & Recent Changes, including expectations for APIs & IMPs 11th November 2008

Neil Raw -GMP Inspector MHRA
Richard Andrews -Operations Manager MHRA

API audits by 3rd Party Auditors are regarded as suitable by MHRA on the following basis:

• The scope of the audit must be clearly defined and must include appropriate/defined elements of the supply chain.
• Auditors must be appropriately qualified.
• A 3rd party auditor may provide audit reports to multiple Manufacturing Authorisation holders.
• Manufacturing Authorisation holders may make use of such a report as far as the scope is fully pertinent to the APIs in question.
• If auditing as a 3rd party, have a technical agreement with the contract giver complying with chapter 7 of the EU GMP Guide and have no vested interests in the outcome.

EMA statement on third party GMP audits 2006 »

EU GMP Guide Part II Basic Requirements for Active Substances used as Starting Materials - GMP compliance for Active Substances »

GMP Auditing FAQs »