The 11th version of the European Pharmacopoeia (Ph.Eur.) is now available. The latest edition includes some updated monographs which will be implemented on 01 January 2023.
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.
In the EU, the so-called EU Whistleblowing Directive was launched in 2019. However, implementation in the Member States is not entirely uniform.
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 German BfArM now clarified for medical Cannabis Manufacturers: A valid GMP certificate must be included with the drying step.
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 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?