Quality System and Audit

BlueReg experienced consultants can provide full support in designing and implementing a quality system that meets regulatory expectations in France.

Our services include:

  • Advice and operational support for pharmaceutical companies located in France for a quality system that meets regulatory expectations for an “Exploitant” status
  • Provision of deputy “Exploitant” Qualified Person (QP)
  • Risk analysis / process mapping
  • Advice, review or preparation of:
    • Product Quality Reviews (PQR)
    • Client-customised standard operating procedures (SOPs) or quality manuals,
    • Quality technical agreements
    • Application for obtaining the “Exploitant” status from the French National Agency for the Safety of Medicines and Health Products (ANSM) and annual reports
    • Contingency plans for drug shortage (shortage management plans (PGP)) for medicinal products of major therapeutic interest (MITM)
    • Serialisation
  • Audits of pharmaceutical processes according to good manufacturing practice (GMP), good distribution practice (GDP) or “Exploitant” activities
  • Preparation and support prior to ANSM inspection

 

BlueReg regulatory consultancy in Registration

Audits

BlueReg understands the requirements of the health authorities concerning audits and what to expect. Thus, we can provide a complete audit preparation package which we can tailor to your needs, including:

 

  • Standard Operating Procedure (SOP) reviewing/writing
  • Pharmacovigilance System Master File (PSMF) reviewing/writing
  • Corrective Action Preventive Action (CAPA) review
  • Setting up/reviewing a Quality Management System (QMS)
  • Data review of relevant documentation/certification/procedures
  • Conducting audits of sites (internal/third party)
  • Conducting mock audits
  • Providing support on-site during the audit
  • Pre-audit training to staff

 

All these activities are carried out in full compliance with Good Clinical Practices, Good Manufacturing Practices, Good Vigilance Practices and local standards as applicable.

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