20/21 November 2019
The EDQM recently issued a press release entitled: "Microbiological control symposium: consensus on readiness of new methods
emerges" relating to EDQMs symposium on microbiology in the pharmaceutical sector on 10 and 11 October in Strasbourg.
Background for organizing the symposium was the fact that several chapters of the European Pharmacopoeia were revised in the last months, especially "Chapter 5.1.6. Alternative methods for control of microbiological quality" one of the most important chapters with focus on the development of new and rapid microbiological methods. The EDQM states :"5.1.6 in particular was recently further revised to take into full account the latest technological developments and to provide clear guidance for validating alternative microbiological methods."
For the European Directorate for the Quality of Medicines and HealthCare such a symposium offers the possibility to get further comments from industrial and and scientific experts and users about their experiences using the EP chapters on alternative testing methods for
microbiological control and sterilisation processes.
As the EDQM writes in the press realease "a consensus emerged among participants that alternative methods for the detection, enumeration and identification of microorganisms are at present sufficiently well covered in Pharmacopoeias world-wide. General agreement was also reached that developments in Pharmacopoeias now allow manufacturers of medicines to start using modern technologies for effective microbiological control."
Furthermore, additional microbiological topics like the use of biological indicators or methods for the control of cell therapy products were discussed and gave the participants an opportunity to learn about new methods, their implementation and potential benefits as well as possible pitfalls.
For more details please read the EDQM press release "Microbiological control symposium: consensus on readiness of new methods
If you want to learn more about the latest microbiology relevant revisions in the European Pharmacopoeia, visit PharmaLab 2017 with the special session on "Microbiology Pharmacopoeial Updates" where Dr. Sebastien Jouette from the EDQM, Radhakrishna Tirumalai from the USP and other speakers will present the new developments and last revisions of the EP and USP.