In March this year World Health Organization (WHO) published a draft guideline on GMP for excipients used in pharmaceutical products. Document is open for public consultation until 21st of May 2023. A final version of the revised guideline is planned for October 2023.
Excipients play an essential role in pharmaceutical dosage forms and their impact on the quality of the finished product is considerable. The guideline is addressed to excipient manufacturers and pharmaceutical manufacturers. Guideline assists pharmaceutical manufacturers in better assessing the quality of the excipients used and it also supports excipient manufacturers to produce and control excipients to meet their intended specifications, in a consistent manner. The need to revise the guideline was also strongly supported by recent WHO medical alerts which, among other things, were based on a lack of quality of the used excipients.
The concept of ongoing improvement combined with a life cycle approach, better quality management systems, risk management and management review is described in one guideline, alongside the necessary good storage, good trade and good distribution practices to ensure their reliability throughout the supply chain. This includes, for example:
- a senior management that takes responsibility for the quality management system and the overall product quality of the excipients used in pharmaceuticals,
- a reliable documentation and records system according to the requirements for good documentation practice and computerised systems,
- self-inspections, quality audits and supplier audits,
- the review and documentation of complaints, returns and recalls,
- the review and documentation of changes and deviations and rejected batches,
- qualified personnel,
- personal hygiene,
- protection against contamination,
- risk-based qualification and validation processes in the production area