GMP News

FDA Warning Letter on misbranded and unapproved Drugs

Due to ignorance of the FDA definition of drugs, a US pharmaceutical company has received a Warning Letter regarding their products.

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New Regulation on Blood, Blood Products and Plasma

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.

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EMA and FDA publish Q&A Document on their accelerated Approval Programmes

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".

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FDA Draft Guidance on Potency Assays for Cellular and Gene Therapy Products

At the end of December, the FDA published a new draft guidance document on potency assays for Cell and Gentherapeutics.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.

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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.

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New USP Chapter on Cured Silicone Components

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.

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What is an FDA Post-Warning Letter Meeting?

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?

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Pest Control - Warning Letter to US Company

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.

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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.

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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.

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Another FDA Warning Letter for Chinese Company based on Review of Records

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.

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What is the African Medicines Agency?

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).

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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.

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Swissmedic: Nitrosamine Requirements updated

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.

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Frequency and Quality of Foreign FDA Inspections

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.

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New Entries in the ECA Discussion Forum

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.

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Abbreviations in the GDP Environment - Extended List

During GDP events organised by the ECA, the wish came up to compile a list of relevant abbreviations used in the GDP environment. The overview first published a few months ago has now been extended.

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Checklist for Implementation of GDP Principles - Part 4: Documentation

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.

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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.

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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.

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FDA Warning Letter for Chinese Company based on Review of Records

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.

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Cloud Computing: Workaround for non-compliant PaaS

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?

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VICH: Guideline for Active Pharmaceutical Ingredients in Veterinary Medicinal Products

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.

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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.

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EMA: FAQs for the Use of IRIS

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.

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