Wednesday 18 November 2020

A GMP for R&D?

The World Health Organisation published a new draft guideline on Good Manufacturing Practice (GMP) for development batches. WHO indicates that this will become the first GxP guidance for R&D.

The main focus of the document is on pharmaceutical formulation and development, general research and development, production of investigational medicinal products (IMPs) and pilot scale batches.

The guidance also covers process validation; cleaning procedure development; cleaning validation studies; as well as stability studies, in relation to development batches. Also, development, validation and transfer of manufacturing processes and analytical procedures.


The document also indicates that:

  1. The validation of R&D processes (which comes under “process design”), needs to cover the design of experiments (DoE), process development (ICH Q8), the manufacture of products for use in clinical trials, pilot-scale batches and transfer. 
  2. Analytical R&D procedures should be appropriately recorded and validated (ICH Q14). As the procedures are usually intended to be transferred to QC units in manufacturing facilities of commercial batches, procedures and records should be sufficiently detailed to ensure that transfer will be successful.

Here is the link:

Consultation ends on 6th January, 2021.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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