FDA Warning Letter Defines Minimum Criteria for Process Validation
In addition to 21 CFR 210/211 and the related Guides to Inspection of as well as Guidelines/Guidances for Industry, Warning Letters are another way of interpreting the US cGMP regulations. Read more here about FDA's response to a pharmaceutical manufacturer's reference to not being aware of the need to perform process validation.
The EMA published revised Questions & Answers on the EU framework for (traditional) herbal medicinal products, including those from a “non-European” tradition. Amongst others two new interesting questions with corresponding answers regarding GACP and GMP have been introduced.
Is it Acceptable to Mix Extract-Batches in order to Improve Batch-to-Batch Consistency?
A revision of the "Questions & answers on quality of herbal medicinal products/traditional herbal medicinal products" document was published on the website of the European Medicines Agency (EMA) on 1 February 2024.
EMA/CHMP/CVMP: New Q&A document for the Use of CEPs
In the middle of February, the document "QWP Questions and Answers (Q&A): how to use a CEP in the context of a Marketing Authorization Application (MAA) or a Marketing Authorization Variation (MAV)" prepared by the EMA, the CHMP (Committee for Medicinal Products for Human Use) and the CVMP (Committee for Medicinal Products for Veterinary use) was published on the EMA website for the first time.
When reading an FDA Warning Letter, you might have recognised that under GDUFA programme, the facility may be eligible for a so-called Post-Warning Letter Meeting. But what is this?
FDA Warning Letter: Data Integrity issues while manufacturing APIs
In February 2024, the U.S. FDA issued a Warning Letter to the Chinese company "Sichuan Deebio Pharmaceutical Co. Ltd." after having inspected its site in September 2023. According to the Warning Letter the firm has a lack of microbiology laboratory Data Integrity.
FDA Guideline "Advanced Manufacturing Technologies Program" published as a Draft
The FDA defines advanced manufacturing as innovative pharmaceutical manufacturing technologies or an approach with the potential to improve the reliability and robustness of the manufacturing and supply chain. The FDA encourages the early adoption of such advanced manufacturing technologies and has established a programme for this purpose.
The EMA has received a grant of ten million euros from the European Commission to support regulatory systems in Africa, and in particular for the setting up of the African Medicines Agency (AMA).
EMA/HMA/ECA: List of Active Substances defined to prevent supply bottlenecks
As part of the measurements against supply shortages in the pharmaceutical sector, the first version of the "Union list of critical medicines" and further information on this was published on the EMA website at the end of last year. This list contains more than 200 active substances that are considered critical in the event of a supply shortage and whose shortage must be avoided at all costs.
Swissmedic's nitrosamine Q&A document "Update of the requirements for dealing with nitrosamine impurities in medicinal products" was updated in January 2024 and is now available in the new version on the Swissmedic website.
FDA Warning Letter: Observed particulates in repackaged drug components
In January 2024, the U.S. FDA issued a Warning Letter (WL) to the Mexican company "Glicerinas Industriales, S.A. de C.V." after having inspected its site in May 2023. According to U.S. FDA Warning Letter, the firm failed to do adequate investigations on observed contamination of particles in numerous packaged drugs.
FDA answers Questions on Remote Regulatory Assessments
The FDA has revised its Draft Guidance for Industry "Conducting Remote Regulatory Assessments - Questions and Answers", providing answers to frequently asked questions regarding what RRAs are, when and why FDA may use them, and how FDA may conduct them, among others.
EMA: Further Update of the Q&A Documents on "Centralised Procedures"
In December 2023, the Questions & Answers (Q&A) documents related to centralised procedures were revised again and published on the European Medicines Agency (EMA) website. The list of Q&As, which can be used by marketing authorisation holders and applicants for centralised procedures, provide answers to any questions that may arise at different stages of the centralised marketing authorisation application.
In January, the question and answer catalogue "RPM for PLM (Regulatory Procedure Management for the Product Lifecycle Management) - Frequently Asked Questions and Answers" was published on the EMA website. In addition to the glossary, it contains 23 questions and their answers relating to the use of the IRIS system.
EDQM: Addendum 11.5 to the European Pharmacopoeia available
The Supplement 11.5 to the European Pharmacopoeia (Ph.Eur.) is now available and will be implemented on 01 July 2024. All CEP holders are required to harmonise their specifications and thus the respective CEPs with the new monographs.