EDQM Survey on new General Chapter on microbiological Control of Tissue
Recommendation
18/19 February 2025
Vienna, Austria
All you need to know
Register now for ECA's GMP Newsletter
Related to the fact that the number of tissue based products is increasing and that the microbiological control of such products generates new challenges, the European Directorate for the Quality Medicines and Healthcare (EDQM) has decided to elaborate a new general chapter on microbiological control of tissue.
Therefore they created a survey with the aim to gather information from relevant stakeholders. The provided input is supposed to enable the Ph. Eur. experts in charge of the elaboration of this chapter to have a clear vision on the current situation regarding the characteristics of tissue preparations used in Europe and how they are monitored with regard to microbiological control.
The ECA and ECAs Pharmaceutical Microbiology Working Group want to support the EDQM in evaluating suitable data and comments and thus forward the information about that questionnaire with this news.
The survey European Pharmacopoeia - Microbiological control of tissues takes only 5-10 minutes to complete. It is open until 2. September 2016.
Related GMP News
07.11.2024Revision of USP <1085> "Guidelines on Endotoxin Test"
24.09.2024USP follows the 3R Principle - Implementation of new Chapter on recombinant Test Methods
28.08.2024The Effectiveness of Disinfectant Agents: An Overview
05.06.2024Handling of Microbiological Deviations and Sterility Testing - FDA publishes Warning Letter
07.05.2024HTS/NGS - Draft Ph.Eur. Chapter "High-Throughput Sequencing for detecting Viral Extraneous Agents"
31.01.2024EMA publishes new questions and answers on Annex 1