Warning Letters from the US FDA provide an interesting guide to interpreting the FDA's CGMP regulations. A current Warning Letter shows interesting considerations of the FDA regarding the tasks of quality assurance. What does the FDA think?
Pharmaceutical cleanrooms are extremely vulnerable in the event of a leak in the cleanroom ceiling area. Water ingress, e.g. due to leaking pipes, operating errors, e.g. with hoses or rain ingress via the building roof, is relatively common. The number of possible individual risks is very high. But what should the first and medium-term measures be?
Questions about the simultaneous use of pharmaceutical equipment for the manufacture of drugs and non-drugs come up again and again. You could also already read about this. In a recent Warning Letter, the FDA has now reaffirmed its position on this issue. What does it say?
Swissmedic has published an updated version of the Technical Interpretation "Responsible Person: Requirements (I-SMI.TI.17e)", which includes numerous clarifications. Although compliance with the previous version typically remains sufficient, some situations may require immediate action from license holders. The new interpretation is effective immediately.
The Parenteral Drug Association (PDA) has published a new document - Technical Report No. 46 (Revised 2024): Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users. It provides details on temperature control, monitoring and security, and data management, with a focus on supply chain management. Furthermore, the document covers supply chains in Europe, Africa, Brazil, U.S., Canada and China.
The competent authority of Germany (Bezirksregierung Koeln) has issued a new GDP Non-Compliance Report in the EudraGMDP database. During a reinspection, it was found that the issues from the inspection in October 2023 had not been resolved. Furthermore, new critical and serious findings were identified.
Chapter 10 of the EU GDP Guidelines describes the requirements for brokers. In this article, you will find a checklist to verify the minimum implementation.
The FDA has published a comprehensive guidance recommendation to assist biosimilar applicants with manufacturing changes. Through the question-and-answer format, the FDA provides insights and recommendations to promote the development of these important therapeutic alternatives, while also seeking to collaborate with industry to effectively shape future biosimilar guidance.
PharmaLab Congress will take place from 25-27 November 2024 in Düsseldorf/Neuss. This year, the program includes a new track on Analytical Instrument Qualification and System Validation, where several Board members of the ECA Analytical Quality Control Group (AQCG) will be part of the speaker team.
The 'Concept paper on the revision of the guideline on the chemistry of active substances' of the Quality Working Party (QWP) was used to revise and update the 'Guideline on the chemistry of active substances (EMA/454576/2016)'. This guideline's draft revision 1 was published in July 2024 and is available for public comment until the end of January 2025.