We offer pragmatic support tailored to your regulatory and operational imperatives.
Establishment of specifications (5.28 and chapter 7 of the GMP)
According to the report of the ANSM following the inspection campaign carried out from 09/11/15 to 09/03/16 on the topic of the management of Starting Materials for Pharmaceutical Use, 72% of manufacturers of FP have a valid specification with API manufacturers / distributors. (46% have a valid specification for excipients)
We set up for you the adapted specifications by talking directly with your supplier. These specifications are also needed for outsourced activities (eg transport, storage, etc.).
Management Plan of the Shortages – Opposable since 22/01/2017: We establish a shortage management plan especially for Medicines of Major Therapeutic Interest through the risk analysis of your Supply Chain.
Product Quality Review (PQR) (1.10 GMP): We review the PQR prepared or received according to the recommendations issued by the ANSM in January 2017.
Operational Support in Quality Assurance (part time, support mission pre or post inspection): We intervene on your site and participate in your Quality System for full-time or part-time missions. Junior, confirmed or senior consultant depending on mission and availability.