Context and challenges
The client is a pharmaceutical firm responsible for manufacturing drugs not available from private industrial manufacturers, on behalf of a public health institution. In particular, it manufactures specialised paediatric products and drugs for rare, neglected diseases. The client operates a genuine pharmaceutical production unit housed within this public institution, and is subject to Good Manufacturing Practices (GMP) regulations and inspections by the ANSM (French National Agency for Medicines and health product Safety).
In this context, this client appointed Assystem to carry out a diagnosis according to ICH Q10 "pharmaceutical quality system" and ICH Q9 "quality risk management" and the establishment of a roadmap to improve its Pharmaceutical Quality System (PQS).
Evaluation of the maturity of the Pharmaceutical Quality System (PQS):