Contaminated equipment, OOS results in microbiological testing, and failures in control of incoming goods led to a Warning Letter from the FDA to a U.S. OTC manufacturer.
One of the most important documents in the context of medical device regulation is the technical documentation. Recently updated to version 2, a helpful position paper from Team Notified Body serves as a best practice guide on this topic. Read more here.
The Committee on Herbal Medicinal Products (HMPC) adopted the Concept paper on the development of a Reflection Paper on modern manufacturing techniques used for herbal preparations. The proposed reflection paper should support the industry in the development and application of modern manufacturing methods regarding herbal preparations.
The Danish Medicines Agency clarified that the Danish monograph for Cannabis Flower will become invalid and removed from the Executive Order on Danish Drug Standards once the Ph. Eur. Cannabis monograph becomes official.
The USP adopted the new general chapter <1567> Pyrrolizidine Alkaloids as Contaminants. Twenty-eight PAs are selected to be monitored and manufacturers of herbal medicinal products should use a risk-based approach for determining appropriate limits and testing requirements.
The USP proposed a new General Chapter <2800> Multi-Ingredient Dietary Supplement Products - Product Quality Tests in the Pharmacopeial Forum. The chapter is intended as an informational chapter, not as a requirement for compliance.
The passages amended in the last update of the Q&A document of the EMA/CMDh refer, among other things, to the no longer required setting of temporary acceptable intake limits for nitrosamines. This has important consequences for marketing authorisation holders for the feedback of nitrosamine impurities to the authorities.
A US drug manufacturing company received a Warning Letter from FDA mentioning several failures "to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components".
PIC/S is a collaboration of regulatory agencies in the field of GMP for human and veterinary medicines. The goal of PIC/S is to provide harmonized standards and training to ensure that one inspection per site will also be recognized by every other authority. The 2022 report provides an overview of PIC/S activities for that year. What does it include?
Artificial intelligence (AI) is revolutionising industry, and the pharmaceutical sector is no exception. One might think AI reaches its limits when it comes to GMP. But there are promising possibilities.