Quality
Quality
Quality system
Quality system of the three plants is managed at a corporate level to assure maximum consistency in compliance to cGMP regulations as per 21 CFR 210/211, EU GMP Guide Part 2 and ICH Q7A.
The successful inspection track record accumulated over the years is the proof of a sound and established knowledge of quality and regulatory aspects. This gives to us and to the customer confidence to smoothly operate even in the most regulated markets.
QUALITY
A comprehensive approach
Whether it is a clinical trial batch, a commercial API campaign or a regulatory starting material, we reserve to all compounds the same, comprehensive care. All our production facilities operate in full GMP, with product isolation in ISO8-like environment, and we take care of all ancillary quality processes as necessary: process validation, supplier audit and qualification, evaluation of impurities and their fate, definition of design spaces, toxicological evaluation, cleaning validation, PQRs, and so on.
Quality
Inspections
AMSA, Cosma and Clarochem plants are routinely inspected by international regulatory authorities including US FDA, Italian AIFA, Irish HPRA, Korean KFDA and so on.
Such extensive routine GMP surveillance, as well as the excellent track record over the years, often result in the grant of pre-approval inspection waivers by regulatory authorities.
Furthermore, the group plants also receive an average of an audit every week from a great number of demanding clients.
