Dr Afshin Hosseiny, who has been the European GDP Association's Advisory Board Chairman since its foundation, has decided to step down from this position. For this reason, Alfred Hunt joined as the Deputy Chair in 2021. After a year of the two working together, Alfred Hunt has now taken over the role as the Chairman.
In the Pharmacopeial Forum, PF 48(4), a proposal for a new USP chapter <1079.3> Monitoring Devices—Time, Temperature, and Humidity, providing background information about the science and technology of temperature and humidity monitoring over time, has been published for comments.
The electronic application forms for submission of variations (eAFs) for medicinal products for human and veterinary use were updated in June and are listed in the latest versions on EMA's eSubmission website.
The EMA and CMDh question and answer collection on nitrosamine impurities in APIs and medicinal products is a "living" document that is updated at irregular but short notice intervals. You can find out here which current requirements and changes with regard to nitrosamine impurity limits, risk assessments and reporting obligations are important for marketing authorisation holders.
Almost 1,600 interested colleagues downloaded version 1 of the ECA Expert Task Force's Contamination Control Strategy Guide from the ECA Foundation website - and numerous comments came in. This feedback has now been incorporated into a revised version of the CCS Guide.
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a South Korean manufacturer of OTC drug products. During an FDA laboratory testing of a batch of hand sanitizer, the impurity benzene at unacceptable levels was found. After a review of records and other information provided by the manufacturer, the FDA came to the conclusion that the quality assurance within the facility is not functioning in accordance with CGMP requirements.
The FDA posted several Warning Letters to companies illegally selling cannabidiol products intended for use in food-producing animals due to safety concerns. The agency is taking these steps to protect animals and the safety of the food supply chain.
The FDA posted an article on the ways the FDA is regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food, and cosmetics. How can you know for sure that a product is FDA-approved?
In the Pharmacopeial Forum, PF 48(4), revisions of USP chapters <761> Nuclear Magnetic Resonance Spectroscopy and <1761> Applications of Nuclear Magnetic Resonance Spectroscopy are being proposed. Comments can be submitted until September 30, 2022.
The European Commission published a new version of the Questions & Answers (Q&As) regarding the safety features for medicinal products for human use. Is it allowed to verify the authenticity of the UI when the product is not in physical possession?
The recently published EMA Annual Report 2021 gives a good overview of the Agency's activities in the first chapter, such as actions related to the management of the COVID 19 pandemic, work related to the scientific evaluation of medicinal products and their monitoring.
Before approving an application, the FDA must determine whether the drug product is both safe and effective for use. A new draft guidance describes the FDA principles when conducting product quality-related assessments of CMC information.
Since May 2022, the new version of the "IRIS guide for applicants" is available on the EMA website. Besides formal adaptations, version 2.10 contains additions in chapter 7 and updates in chapters 2 and 6.
Growers and importers of cannabis flowers have reported to the German BfArM that the specification requirements of the DAB monograph Cannabis Flower cannot be met, especially for low cannabinoid contents. The BfArM has now worked out a compromise for cannabis used for magistral preparations.
In the Pharmeuropa Bio & Scientific Notes, a free online journal of the EDQM, a new scientific article entitled "Weighing according to the European Pharmacopoeia: general considerations and new general chapter 2.1.7. Balances for analytical purposes" was published.
The U.S. Food and Drug Administration (FDA) published a Form 483 after an inspection at an Indian drug manufacturing side. The lack of control over compression machines settings led to not meeting the dissolution specifications. As the investigations were limited to the directly affected batch only, it is not excluded that other products may be affected by the same problem. Furthermore, the stability program was not followed to complete the testing within the predefined time frame.