News on the Regulation on standards of quality and safety of substances of human origin (SoHO). The regulation are intended to help ensure that the donation and processing of blood, blood products and plasma reflect the latest legal, political and scientific standards.
In December, the EMA and U.S. FDA published a joint Q&A document on accelerated approval of important innovative medicines and therapies entitled: "EMA-FDA joint Q&As on Quality and GMP aspects of PRIME/Breakthrough therapy applications".
At the end of December, the FDA published a new draft guidance document on potency assays for Cell and Gentherapeutics. In addition to recommendations for potency testing, this guidance is also intended to help with the overall strategy for ensuring potency.
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.
The final text for USP <383> Cured Silicone Elastomers for Pharmaceutical Packaging and Manufacturing Components has been published in the USP. The chapter will become official on 1 December 2027. Early adoption of the requirements in this chapter is permitted by USP.
Even animals with legs can keep the regulatory authorities busy. In December, a US manufacturer received a Warning Letter, the first section of which deals with deficiencies in the area of pest control.
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.
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 U.S. Food and Drug Administration (FDA) has issued another Warning Letter to a Chinese manufacturer regarding significant violations of cGMP regulations for finished pharmaceuticals, based on a review of records.
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.
The House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing, which focused on the comparative frequency and quality of FDA inspections for foreign versus domestic drug manufacturers. Read more in our GMP News.
The European GDP Association offers a Discussion Forum free of charge for its members. It gives you the opportunity to address your GDP-related questions to a large audience. Several interesting topics have been discussed over the last few weeks. To get an idea, take a look here.
Chapter 4 of the EU GDP Guidelines points out that good documentation constitutes are an essential part of the quality system. In this article, you will find a checklist to verify the minimum implementation.
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.
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.
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Chinese manufacturer regarding significant violations of cGMP regulations for finished pharmaceuticals. The firm failed to conduct proper analytical testing of incoming API lots and relied solely on supplier COAs without verifying the information. Additionally, there was a lack of documentation for the stability program.
Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 19: A non-(GXP-)qualified PAAS could change the versions of some of its generic microservices used by the application to be deployed as a GXP SAAS. Changing the versions of such generic microservices could be beyond the control of the SAAS provider. What would be required to make this scenario GXP-compliant?
The draft guideline "Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products - VICH GL 60" of the VICH can still be commented on until the end of March 2024. Comments can be submitted via the U.S. FDA website, for example.
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.