ISO quality: 5 sites are certified ISO 9001, 2008 version.  The last follow-up audits raised no observations. At each PCAS sites, an experienced and qualified Quality Assurance team maintains local compliance with the applicable standards.

Rationalized quality

PCAS's quality system is designed as a value-added function.  Multiple step synthesis is split between the ISO 9001 and the cGMP sites according to their criticality (the cost of quality in the cGMP units is 50 - 100% higher than in the ISO 9001 units).  The cGMP units use the synthesized intermediates produced at the ISO 9001 sites.  The raw materials purchasing group has been centralized and optimized.  Such synergy allows the global cost of the synthesis to be optimised and makes quality a continuous and transversal process which forms part of PCAS's added-value.

Your projects are not all the same and you may have specific requirements, for that purpose, a modular "MPPS" * tool kit is available (local SOPs) and allows manufacturing, QA and QC practices and standards sized to your specific needs and budget.

MPPS = Matière Première pour Produit de Santé, those were initially additional standards to be considered for the production of e.g. API starting material or used for the synthesis of health products. The principle is extended to some other productions upon customers request and gets integrated into the manufacturing contract.