Exploitant - Pharmaceutical Establishment

Activities related to Quality

  • Process mapping
    • Mapping creation
    • Risk-based approach to processes in the operating facility
  •  Drawing up a list of SOPs in the context of opening a pharmaceutical establishment
  • Drafting and updating SOPs in line with existing processes and current regulations
  • Drafting of the Quality Manual
  • Drafting of the annual inventory / Site master file
  • Support and advice in preparing the file
  • Document compilation
  • Support during the merger or demerger of pharmaceutical laboratories
  • Identification of MITMs in a product portfolio
  • Advice on MITM provisions (safety stocks, declarations, etc.)
  • Risk analysis (stock-outs, MITM, etc.)
  • Drafting of Shortage Management Plans (SMPs)
  • Updating your quality documents to include MITMs and SMPs
  • Support if one of your product ceases to be marketed
  • Review of PQRs summarized in table format
  • Exhaustive proofreading of the QPRs provided by the manufacturers
  • Action plan or comments for the “N” PQR 
  • Action plan or comments for the “N+1” PQR
  • Creation/update of your quality documents (review form for the Exploitant, etc.)
  • Consulting support in the analysis of your PQRs

Further information

Download the document "La Revue Qualité Produit (RQP)"
Download the document "Les activités d'Exploitant pharmaceutique"

Expertise in reviewing PQRs: our team of consultants has reviewed anually over 150 exploitant PQRs for pharmaceutical products in various formulations.