The European Commission published the revised Draft of Annex 2 "Manufacture of Biological Medicinal Substances and Products for Human Use" for the second public consultation. The deadline for comments is 15th July 2010.
For many biological products manufactured by the pharmaceutical industry, human tissue or cells are "active substances". The Directive 2004/23/EC on Human Tissue and Cells covers only the donation, procurement and testing of the tissues and cells. The fast development in the field of biological products, the increase of various types of biologics such as transgenic derived products as well as ATMP required a new legislation and changes in the GMP Guidance to meet the requirements of Article 5 of Regulation 1394/2007 and to align with details in Directive 2009/120/EC. Significant changes have also been made as a result of the comments received from the first consultation.
An important factor for compiling a suitable regulatory guidance for biological medicinal substances and products are the methods used to manufacture these products. Biological medicinal substances and products can be therefore defined to a large extend referring to their method of manufacture. This Annex now , together with several other Guidelines, gives further guidance for the manufacturing of biologics. It contains two different parts:
The Annex considers two different aspects:
a) Stage of manufacture - for biological active substances to the stage immediately prior to sterilisation, Part II is the main guidance. Guidance for the subsequent manufacturing steps are then covered in Part I. It has to be noted that for some types of product (e.g. cell-based products) all manufacturing steps need to be performed aseptically.
b) Type of product - this annex provides guidance on the full range of medicinal substances and products defined as biological.
The Guideline takes into account the certain specific considerations arising from the biological nature of the products and the processes, which are different to conventional medicinal products, which are manufactured using chemical and physical techniques showing a high degree of consistency. The ways in which biological medicinal products are manufactured, controlled and administered make some particular precautions necessary.
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On behalf of the European Compliance Academy (ECA)