Annex 2 has been revised as a consequence of the restructuring of the GMP guide, the increased breadth of biological products to include several new product types such as transgenic derived products and the Advanced Therapy Medicinal Products, (ATMPs) together with associated new legislation.

This annex, along with several other annexes of the Guide to GMP, provides guidance which supplements that in Part I and in Part II of the Guide. There are two aspects to the scope of this annex:

a) Stage of manufacture - for biological active substances to the point immediately prior to their being rendered sterile, the primary guidance source is Part II. Guidance for the subsequent manufacturing steps of biological products are covered in Part I. For some types of product (e.g. cell-based products) all manufacturing steps need to be conducted aseptically.

b) Type of product - this annex provides guidance on the full range of medicinal substances and products defined as biological.

Outcome:

The second public consultation period ends on July 15, 2010.Send your comments to: entrgmp@ec.europa.eu and ADM-GMDP@ema.europa.eu.

Link:

EC/ Draft Annex 2