Does GMP apply to Development?

In view of the recent need for the fast development of medicinal products for COVID-19, the World Health Organization (WHO) published a new guideline on Good Manufacturing Practice (GMP) for development batches. The deadline for comments is 6 January 2021. According to the WHO, there are currently no regulatory guidelines available which address this matter.

From early research to the final steps of development and formulation

The main focus of the document is on pharmaceutical formulation and development. The WHO document intends to provide guidance on GMP to research and development (R&D). Moreover, other activities including the production of investigational medicinal products (IMPs) and pilot scale batches; process validation; cleaning procedure development; cleaning validation studies; as well as stability studies, are often undertaken in such facilities.

In addition, the WHO previously already released a new Guideline on GMP for IMPs for comment which specifically addresses the requirements and recommendations for products used in clinical trials.

The WHO guideline is applicable to research and development facilities of products manufactured by

  • chemical synthesis,
  • extraction,
  • cell culture or fermentation,
  • recovery from natural sources,
  • any combination of these processes.

It further covers the development, validation and transfer of manufacturing processes and analytical procedures (including methods used for stability testing and cleaning validation). The strength of GMP in R&D should increase (based on risk assessment) as the process proceeds from early research work to the final steps of development and formulation, stability testing, process validation and cleaning validation. 

Process and analytical method validation in R&D

  • The validation of R&D processes is also referred to as “process design”. Process design should normally cover the design of experiments (DoE), process development (ICH Q8), the manufacture of products for use in clinical trials, pilot-scale batches and transfer.

  • 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.

More information can be found in "Good Practices for Research and Development Facilities" on the WHO Medicines website under "Working documents in public consultation".

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