The Committee for Medicinal Products for Human Use (CHMP) adopted the Concept Paper on a Guideline on the Chemical and Pharmaceutical Quality Documentation concerning Biological Investigational Medicinal Products in Clinical Trials. End of consultation and deadline for comments is 31 May 2008.

Currently, for biological/ biotechnological products in development, appropriate guidance is not sufficient (for material of non-biological origin, a respective guideline is already available). The proposed guideline concerning biological IMPs will now address specific aspects relevant to products under development and will address critical quality aspects like:

• Extend of information about the structure of the molecule
• Information on cell banks
• Process and product related impurities
• Manufacturing process, control of critical steps and IPCs
• Extend of development and/ or validation of manufacturing process
• Extend of qualification/ validation required for analytical procedures
• Preliminary specifications
• Stability data
• Change Management

For the ongoing harmonisation process and for the sake of consistency and transparency, it is of great importance to ensure harmonised requirements for the documentation to be submitted throughout the European Community.

For further information, please go to
http://www.emea.europa.eu/pdfs/human/bwp/46609707en.pdf

Author:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)