cGMP guidelines for medicinal production

Manufacturing of active medicinal products is governed by guidelines vol. 4 part I-II published by Eudralex.

This guideline was released in November 2000 as Annex 18 to the GMP Guide in accordance to ICH Q7A and was adopted by producers and GMP inspectors on voluntary basis.

Several EU Directives state that active substance in medicinal products need to be produced in accordance to cGMP rules.

This Guideline provides directions to follow for producers of active substance who need to implement a quality management system.

It also states that production need to ensure appropriate quality, purity and safety of the substance as stated in product specifications.

This guideline refers to all the manufacturing steps: production, quality control, release, storage/biobanking.

Specific guidelines for biological products are included in Annex 2 of vol. 4.

The production of biological medicinal products often encompass complex biological processes and materials, such as expansion and growth of cells or extraction/manipulation of material from living organisms.

This kind of production can present variable parameters to be checked and needs adaptation of existing guidelines also concerning biological quality controls methods.

Biological processes are more susceptible of microbial contamination therefore production units need to be carefully monitored to avoid environmental contaminations sources (air particle, microbiology testing etc).

Also risk of cross-contamination is high in biological production units, therefore careful quality control time-points need to be identified along the productive pathway.

In this respect, Procelltech has developed innovative quality control assays to evaluate sterility, inter and intra-specie cross-contamination and identity of advanced therapy medicinal products in accordance with international guidelines (ICH, EU and US Pharmacopoeia).