Exploitant - Pharmaceutical Establishment
Activities related to Quality
Implementation and improvement of the Quality Management System (QMS)
- 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
Preventing supply shortages of medicinal products of major therapeutic interest ("MITM")
- 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
Product Quality Review (PQR)
- 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
Expertise in reviewing PQRs: our team of consultants has reviewed anually over 150 exploitant PQRs for pharmaceutical products in various formulations.