Testing Methods for Microbiological Control Addressed at Europe Symposium
EDQM held a symposium on microbiology to gather industry feedback on alternative testing methods for microbiological control and sterilization processes.
On October 10–11, 2017, the European Directorate for the Quality of Medicines & Healthcare (EDQM) held a symposium to discuss trends and innovation in microbiology. Pharmacopeial approaches and regulatory requirements were addressed. Participants of the symposium agreed that current pharmacopeial standards worldwide sufficiently covered alternative methods to detect, enumerate, and identify microorganisms.
Topics discussed at the symposium included modern methods for microbiological control, sterilization, biological indicators, rapid microbiological methods, and control methods for cell therapy products and pharmaceutical water. Acceptance of new technologies was also discussed.
Source:
EDQM
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
