Thursday, 16 July 2015

WHO GMP for Biologicals (Draft) - Invitation for Comments


The WHO GMP for biological products (proposed to replacement of TRS 822 annex 1 has been submitted to Expert Committee on Biological Standardization and accepted as a BS document WHO/BS/2015.2253 and posted on WHO biological website to invite public comments. A Comment Form is downloadable from the website below to the document.

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; 
  • propagation of microorganisms in embryos or animals. 
The introduction states:

"This document is intended to serve as a basis for establishing national guidelines for GMP. The main principles and recommendations for manufacturing biological products are provided. If a national regulatory authority (NRA) so desires, these  guidelines may be adopted as definitive national requirements. It is possible that 25 modifications to this document may be justified due to the risk benefit balance and legal considerations in each authority. In such cases, it is recommended that any  modification to the principles and technical specifications of these guidelines should be made only on the condition that the modifications ensure product quality, safety  and efficacy that are at least equivalent to what is recommended in these guidelines."

Here is a direct link to the document.

Posted by Tim Sandle