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

  • 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-customized 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)
    • Serialization

 

  • Audits of pharmaceutical processes according to good manufacturing practice (GMP), good distribution practice (GDP) or “Exploitant” activities
  • Preparation and support prior to ANSM inspection

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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Our experts