Medicinal products release
Every batch of investigational or market authorized medicinal product used in the European Union has to be certified and released by a Qualified Person (QP).
Health-Med offers certification and batch release of:
- medicinal products (MPs) intended for the market,
- investigational medicinal products (IMPs) intended for the use in clinical studies.
Batch certification of already approved medicinal product is defined as a QP confirmation that the batch is of good quality and has been manufactured in compliance with EU GMP (Good Manufacturing Practice) and in line with MA (Marketing Authorisation).
In terms of Investigational medicinal products QP is responsible for certifying that each batch of IMP has been manufactured and tested / checked in accordance with:
- EU GMP
- The Product Specification File
- The IMPD (Investigational Medicinal Product Dossier) or the CTA (Clinical Trial Authorisation)
- The Product Specification File (according Annex 13 to the EU-GMP Guide)
We have a wide experience in batch release and certification of the medicinal products and investigational medicinal products derived from both EU local market and from third countries. Our activities include assessing GMP issues, participating in inspections and audits at sites involved in the manufacturing and distribution of MP/IMPs, being involved in complaint handling and recall processes.
We deal with all aspects related to organization of analytical batch release studies performed in the European Union in contract laboratories audited by Health-Med. Efficient cooperation with contractors and control of product life-cycle before release on the market limit of possible problems with product quality in the future.
Our practice includes certification and release of different pharmaceutical forms of medicinal products including sterile ones.