Pharmacopoeias worldwide have promoted rapid or alternative microbiological methods for almost 20 years. All now have chapters in which the validation of alternative methods is described (e.g. United States Pharmacopeia (USP) <1223>, or European Pharmacopoeia (EP) 5.1.6), and these chapters continue to evolve with frequent updates.
Regulatory bodies have created specific pathways to facilitate the use of modern technologies in recent years. The FDA promotes the use of “Comparability Protocols” and building an Emerging Technologies Team (ETT) for the evaluation of change proposals. The European Medicines Agency (EMA) implemented the post-approval change management protocol and the possibility to request a “scientific advice meeting” with experts.
EU GMP released a new draft of Annex 1, Manufacture of Sterile Medicinal Products for public comment in December 2017. The updated document sets a milestone for adjustments needed within European agencies overseeing regulatory applications of drug products, and environmental monitoring in sterile manufacturing. Some of the top-level changes include:
- After the patchwork of changes made to the 2008 version, the organization of the content has
improved to be more accessible and consistent. For example, quality and manufacturing officers
interested in environmental monitoring will readily find relevant content in Chapter 5 “Premises”
and Chapter 9 “Viable and non-viable environmental and process monitoring”.
- The total number of pages has increased from 16 to 50, the result of the inclusion of more
- Keyword searches demonstrate the increased usage of certain terms in comparison to the
2008 version. For example, the word “risk” can be found 92 times compared to only 20 times before.
Similarly, “microbial” is now present 68 times compared to 23 counts previously.
Download the full paper to learn more about implementation challenges of the industry, Annex 1 changes and more.