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Revised guideline named “ WHO GMP for Biological Products”listed by WHO

The WHO has listed a revised guideline WHO GMP for Biological Products which is a 38-pages guideline and applies to the manufacture, control and testing of biological products for human use, from starting materials and preparations, including seed lots, cell banks, to the finished product.

The guidance document was first published in the WHO Technical Report Series in 1992 and the revised guideline is proposed to be published in final editorial form in the next WHO Technical Report Series. The revision was done in order to include application of risk-based approaches to GMP.

Manufacturing procedures within the scope of the guideline 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



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