Updated guidelines for the preparation of medical products in healthcare establishment and pharmacy
6 October 2017P. Vaconsin, C. Vilain, A. Le, V. Salomon Agence Nationale de Sécurité du Médicament et des produits de santé, 93200 Saint-Denis, France
Pharmaceutical preparations are a major task for both community and hospital pharmacies, in order to make available adequate and validated formulations, and to cover the special needs for the use of an individual patient. Demands and expectations from healthcare professionals and patients are high. The management of the quality for pharmaceutical preparations is a major challenge for patient safety.
In France, the production from community and hospital pharmacies is currently regulated by the “Good Preparation Practices”, issued in 2007 (Bonnes Pratiques de Préparation, BPP).
The aim is to revise the text, by integrating a risk assessment and by reinforcing the quality requirements for each type of preparation, taking into account the state-of-the-art and the current organizations.
In March 2016 a Temporary Specialized Scientific Committee (CSST) has been created, at the French National Agency for Medicines and Health Products Safety, in order to exchange between the different stakeholders: community and hospital pharmacies, academics and Inspectorate body (Regional Health Agencies). The members of the CSST have been selected according to their knowledge and qualifications in, premises, activities, risks management …. They provide expertise and advices in order to update the BPP. The work is based on the coordination between community and hospital pharmacists inspectors, Pharmacopoeia and regulatory affairs experts. Hearings are planned during the process of drafting documents. A public consultation of the final text is planned for 2018. The CSST will provide assistance to analyze the feedback.
Main expected results are:
- a document close to the GMP documentation
- tools to help in the decisions for manufacturing preparations
- guidelines to define the expected quality level, depending on the appropriate risk of the pharmaceutical preparation