WHO Technical Report - GMP for Biological Products Revision

Recommendation

7/8 May 2024

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals - Live Online Training
Regulatory Requirements and Practical Implementation

The World Health Organization (WHO) provides a Technical Report Series on their website with guidance documents comprising general recommendations for biological products.

The current document "Good Manufacturing Practices for biological products; Adopted 1991, TRS no 822, Annex 1" is now supposed to be revised. Thus the Expert Committee on Biological Products published a proposed replacement of this document. This draft was developed based on the outcomes and consensus of the WHO informal consultation convened in July 2014 with participants from national regulatory  authorities,  national control laboratories, manufacturers and academia researchers. It is furthermore supposed to include comments from the public consultation on the WHO website. Additional comments can be submitted to the WHO until 14 September 2015.

The document is supposed to serve as a basis and reference/guide for the generation of appropriate/suitable national guidelines. Possibly there will be modifications/changes necessary in comparison with this document, based on a risk/benefit assessment and legal considerations of the respective national authority.

The scope of this guidance document is defined as follows:

"These  guidelines apply  to  the  commercial  manufacture, control and testing of biological products from starting materials and preparations, including seed lots, cell banks and intermediates, through to the finished products. Manufacturing procedures within the scope of these guidelines include:

• growth of strains of microorganisms and eukaryotic cells
• extraction of substances from biological tissues, including human, animal and plant tissues and fungi
• recombinant DNA (rDNA) techniques
• hybridoma techniques and
• propagation of microorganisms in embryos or animals"

The complete text and contact data for the submission of comments can be found at WHO GMP for Biological Products - Proposed replacement of: TRS 822, Annex 1.