Do the regulatory authorities accept third party audits?
Yes the regulatory authorities do accept third party audits. PharmAssess™ audit reports have been accepted by all regulatory authorities to whom they have been presented. Click on the links below for the views of the European Medicines Agency on third party audits: 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 » MHRA statement on 3rd Party audits » Further information on regulatory and procedural guidance is available on the EMA website.
