BioManufacturing

Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use. The principles and guidelines for GMP for human medicines are stated in Directive 2003/94/EC.

Volume 4 of "The rules governing medicinal products in the European Union" (EudraLex) contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human use. See Commission website for further information. The quality of a biological medicinal product is ensured through a rigorous manufacturing process. Annex 2 of EudraLex Volume 4 provides specific guidance on the manufacture of biological active substances and Medicinal Products for Human Use.

In addition, the Commission has published detailed GMP guidelines in line with those principles in EudraLex Volume 4. In this context, the Commission is revising on a regular basis the GMP guidelines, in collaboration with the European Medicines Agency. The guidelines are revised to take into account the advancement of scientific practices.

The EMA is involved in the harmonisation and co-ordination of GMP and GDP activities at an EU level. It is involved in:

  • coordinating the preparation of new and revised guidance on GMP and GDP.
  • coordinating advice on the interpretation of EU GMP and GDP requirements and related technical issues.

The EBE BioManufacturing WG provides a forum for manufacturers to raise, discuss and address issues relating to the manufacture of biological products. The current priorities for the WG include:

BWP Workshop

The Biologics Working Party (BWP) provides recommendations to the European Medicines Agency's scientific committeeson all matters relating directly or indirectly to quality and safety aspects relating to biological and biotechnological medicines. The EBE has provided industry input and support to a series of Expert Workshops organised by the BWP. In 2013 the Workshop addressed some topics on Setting Specifications identified by the BWP, in order to provide input in advance of the development of a guideline on Setting Specifications.

Satellite symposium at the CASSS CMC Forum

The CASSS CMC Strategy Forums held in Europe provide a venue for industry and regulators to discuss issues of mutual concern. For the second year, the BioManufacturing WG has organised a Satellite Symposium at the CASSS meeting and in 2013 this was used as a forum to follow up on a number of unresolved issues from the BWP Experts Workshop on Setting Specifications.

Concept Papers

The EBE BioManufacturing WG has produced a series of Concept Papers each addressing a specific topic. The aim of the EBE Concept Papers is twofold. First, to act as a practical implementation guide for manufacturers, bridging the gap between guidelines and manufacturing practice and secondly, to provide an industry position for discussion with the regulatory authorities.

Two Concept Papers were finalised in 2013 on Platform Manufacture and Setting Spefications. A new Concept Paper on Forced Degradation Studies is planned.

Position Papers

The WG may also develop Position Papers on manufacturing issues. Currently, a position paper on Visible Particles is under development.

Regulatory Input

The WG will provide industry input, as required, on proposed legislation and guidelines.