project

Diagnosis and action plan to improve a Pharmaceutical Quality System

Compliance & Remediation Life Sciences France

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).

Logo Assystem Care

Project Scope

Evaluation of the maturity of the Pharmaceutical Quality System (PQS):

  • Grid and criteria according to ICH Q10 and Q9:
    - 5 rating levels per item (31 items explored)
    - Evaluation based on interviews and analysis of the provided documentation
  • Status report with summary sheet for each process:
    - Graphic representation of the maturity of the PQS (clustering of 12 families)
    - Identification of strengths, weaknesses/expectations of Q10 and Q9
    - SWOT analysis of the process
  • Remediation scheme: global synthesis, recommendations, quick wins, priorisation of actions
  • Feasibility study: phasing over 3 years, schedule with identification of resources and possible expertise needs

Results

  • Set up of a process approach in order to improve operations efficiency
  • Delivery of a reusable synthetic document to trace the PQS evolution: graphical representation of the PQS maturity and SWOT structure
  • Adoption by client teams of the proposed methodology and flexible tools
  • Launch of the continuous improvement process deployment

in figures

6

client departments

15

business processes

30

people interviewed

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