Your success – the indicator of our expertise
It is a common practice to purchase active pharmaceutical ingredients from third-party countries when manufacturing medicines. Depending on the country of manufacture and the relevant registration authority, these active ingredients must meet the specific quality standards documented with GMP.
Therefore, many pharmaceutical companies have their foreign suppliers audited by an official institution/authority so they can continue using their active ingredients on the local market.
We fully prepare drug manufacturers for the GMP audit, pursuant to PIC/S standards or in accordance with COFEPRIS.
M.P.I. advises and assists you for a successful Third-Party Audit
Due to our extensive experience with the different guidelines and licensing requirements in each market, we are able to help manufacturing facilities prepare GMP audits.
Our pre-audit team examines the still uncertified factory and indicates the necessary optimisation measures. Our team contacts the respective healthy authority and plans the audit together with the customer and supplier.
This means we assist you in organising official inspections in the third-party country and in adhering to the audit plan. We will be there in person, of course, during the auditors’ visit to the factory.
Take advantage of our expertise for the entire audit process – for the successful authorization of the market launch.
We prepare manufacturers around the world for:
→ API GMP-Audits
→ Assistance with registering the audit with the target country’s health authority (e.g. COFEPRIS, EMA or USFDA)
→ Advice and support during the audit
→ Preparation of the pre-audit report with the support of our chemist