The European Pharmacopoeia (Ph. Eur.) has introduced a new general chapter, Comparability of Alternative Analytical Procedures (5.27), in Supplement 11.5. This chapter was officially adopted by the European Pharmacopoeia Commission during the 176th session in June 2023.
This chapter focuses on the methods for establishing the comparability between alternative and standard pharmacopoeial analytical procedures. It aligns with the directives in section 1.1.2.5 of the Ph. Eur. General Notices, which mention: "…alternative analytical procedures may be used for control purposes, provided that they enable an unequivocal decision to be made as to whether compliance with the standards of the monographs would be achieved if the official procedures were used."
Chapter 5.27, while not setting forth new requirements, serves an informative purpose. It offers practical advice for those opting for an alternative analytical procedure over the traditional pharmacopoeial approach in their testing methodologies. It underscores the necessity of maintaining comparability throughout the lifecycle of both procedures. Furthermore, this chapter might aid assessors in their analysis and suggests that various methods of proving comparability might be valid.
To elaborate on this new chapter, the EDQM will conduct a webinar for interested parties on 17 January 2024, offering a platform for addressing any pertinent inquiries.