August 22nd 2025
The recall was in response to particulate matter found in the container.
Establishing Acceptance Limits for Uniformity of Dosage Units: Part 3
May 2nd 2018The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.
European Pharmacopoeia Commission Sets Quality Requirements for Live Biotherapeutic Products
April 18th 2018The European Pharmacopoeia Commission has approved a general monograph laying down harmonized requirements for LBPs for human use and two general chapters addressing microbiological contamination of LBPs.