Back to Home Page banniere
Products and Services » QA & Regulatory Support » Quality is at the heart of the PCAS organization
QA & Regulatory Support
Quality is at the heart of the PCAS organization

Quality Assurance (QA) at PCAS is a continuous operational process, fully integrated into the organization and company operations.  The deployment of a quality system, homogeneous to all the group's sites, was finalized in 2004.  Guidelines and procedures are now shared by all production units through an electronic management of documents (DOCNET).

Other innovations:
  • Project selection: The selection committee, "Ranking", prioritises projects according to their feasibility and their added-value as well as achieving the expected quality of the manufactured product.
  • Anticipation: The Regulatory Affairs Department's resources are centralized at the Aramon site. This pole of expertise is able to answer to the growing demands of the world-wide health authorities on the quality of the process files - (Master files and regulatory support).

An independent function, but integrated into production processes

PCAS sites apply rigorous quality reference systems.  They are regularly inspected by the FDA or by other health authorities such as AFFSAPS.
  • cGMP quality: Five PCAS sites apply the cGMP system of reference and are FDA inspected, a must for exporting to the USA. A new function of coordinating quality control (QC) coordination was created in 2005 at the five PCAS cGMP sites - (Inspections / GMP Compliance)
  • ISO quality: 5 sites are certified ISO 9001, 2000 version - (fine chemicals sites certification).

Listening to our customers - (Customer request management)

PCAS's quality system is flexible.  Customers regularly visit the sites to audit the methods that the Group knows how to adapt and meet their requirements or specifities.  The ISO 9001, version 2000, system of reference, adopted by all the Group's ISO 9001 sites, is structurally customer-oriented.