GMP News

News on the Windsor Framework for Medicines Supply in Northern Ireland

The MHRA has announced a "long-term solution" of the Windsor Framework for the supply of medicines into Northern Ireland, effective from January 1, 2025. One key issue concerns the packaging and labelling of medicinal products.

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Korean MFSD publishes Revision 7 of Comparative Dissolution Test Guideline

The Korean Ministry of Food and Drug Safety (MFDS) has revised the "Guidelines for Comparative Dissolution Test". A new version dated 18 May 2023 was published.

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ICH GCP Draft Guideline

The ICH E6(R3) draft Guideline on Good Clinical Practice (GCP) is now available for public consultation. It intends to encourage the use of innovation and technologies that have the potential to make clinical trials more efficient.

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How to Deal with Changes to Third-Party Vendors?

The FDA is requesting feedback on factors the agency should consider when reviewing proposed modifications to a risk evaluation and mitigation strategy (REMS) that are prompted by or related to changes in third-party vendors, also known as REMS administrators.

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USP <88> "Biological Reactivity Tests, In Vivo" is currently also undergoing Revision

In the course of the revision of the Chapter on biological reactivity the USP has also published a draft of chapter <88> on in vivo tests. This news presents a summary of the changes.

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Appearance as a Release Test? This is not the Way to get through an Inspection

The FDA has issued a Warning Letter to a manufacturer in the USA who has not adequately tested its drug products. And the manufacturer relied on others for supplier qualification.

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Clean-up Phase and Recovery Time - is there a Difference?

When planning cleanrooms and their HVAC systems, questions often arise regarding "recovery time" and "clean-up phase". Are these different requirements, or are they the same? Do these only apply to sterile or also to non-sterile products? And do they have to be measured in operation or at rest?

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Inadequate Cleaning of Product-Contact Surfaces

In a Warning Letter, the FDA describes the inadequate cleaning of product-contact surfaces and the associated risk of cross-contamination at an Egyptian pharmaceutical manufacturer.

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Updates to the EMA Q&A Documents on Centralised Procedures

In April 2023, the Questions & Answers documents related to centralised marketing authorisation procedures were revised and published on the European Medicines Agency (EMA) website. The Q&As, which can be used by marketing authorisation holders and applicants of centralised procedures, provide answers to potential questions at different stages of the centralised marketing authorisation application process.

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MRA: EU-US Agreement to recognise GMP Inspections for Veterinary Medicines

The Mutual Recognition Agreement (MRA) between the EU and the US will be extended to veterinary medicines. This was announced by the EU Commission in a press release.

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MHRA announces Cooperation with seven international Partners

The U.K Medicines and Healthcare products Regulatory Agency MHRA is working on a new international recognition framework, including EMA and FDA.

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GMP Inspection finds weak points in the GMP training system: How to (not) react

In a recent Warning Letter, the FDA criticises, among other things, an inadequate training system. How to respond to such an inspection deficiency?

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EMA issues Reflection Paper on Demonstrating Efficacy for Advanced Therapies

The European Medicines Agency (EMA) has opened a public consultation on a reflection paper that discusses key concepts for single-arm clinical trials (SATs) for new therapies. According to the agency, this is the first guidance issued by an international medicine regulator articulating the considerations and challenges associated with this type of clinical trials.

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FDA Publishes Final Q&A Paper on Risk-Based Monitoring of Clinical Trials

The U.S. Food and Drug Administration (FDA) published the final Q&A paper on a risk-based approach to monitoring of clinical trials.

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Good Machine Learning Practice: FDA issues Discussion Paper on AI/ML in Drug Development

The U.S. Food and Drug Administration (FDA) issued a discussion paper on "Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products." In particular, the FDA wants to receive feedback on the key areas in the context of AI/ML, including Good Machine Learning Practice (GMLP).

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Guidance on the Identification of Medicinal Products

With the guidance "Identification of Medicinal Products - Implementation and Use" published in March, the FDA addresses all those involved in the submission of medicinal product data.

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FDA Recommendations to reduce HIV Transmission through Blood and Blood Products

The FDA has revised the guidance regarding recommendations for blood establishments to defer donors for persons with an increased risk for human immunodeficiency virus (HIV) transmission.

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Publication of the 21st Edition of the EDQM Blood Guide

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the 21st edition of the "Guide to the preparation, use and quality assurance of blood components".

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FDA Form 483 due to Insufficient Investigations after OOS and OOT Results

The U.S. Food and Drug Administration (FDA) has published a Form 483. During an inspection at an Indian drug manufacturing side, several CGMP violations were documented. These concerns, among others, Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, where results were invalidated by retesting the batches without a scientifically justified root cause.

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Registration of APIs in Brazil - Q&As

In March 2023, the ECA offered the Live Online Training "How to register APIs in Brazil". With regard to Brazil's Registration procedures for APIs, a set of the most important questions raised during the training and the respective answers provided by the speakers Ms Marieke van Dalen, Global Regulatory Specialist, Aspen, The Netherlands, and Ms Susan Swiggers, Customer & Regulatory Support Officer, Aspen, The Netherlands, are listed in the following.

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What does the FDA actually mean by CGMP?

Good Manufacturing Practice is referred to as GMP in the EU, in almost all PIC/S countries and at WHO. The FDA, however, refers to it as CGMP. But what exactly is behind it? The FDA has published a paper on this.

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The European Qualified Person - What's it all about?

If you are a non-EU based company exporting drug products into the EU, it is essential to understand the role of a QP. It's also helpful to understand all other EU-GMP requirements to be better prepared for inspections.

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APIC: ICH M7 "How to Do" Document published

The first version of the "Sharing Drug Substance M7 information to HA and MAH: "How to do" document -Interpretation of the ICH M7 guideline and other relevant guidelines with regard to M7 data sharing" and the associated templates were finalised in March and April 2023 and are now available on the APIC website.

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Consequences of manufacturing non-pharmaceutical Products on pharmaceutical Equipment

In October 2022 you could already find out in a news that the FDA does not accept the manufacture of medicinal products on equipment that is also used to manufacture non-pharmaceutical products. But what are the consequences if the FDA does discover such manufacturing?

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USP: Chapter "<2> Oral Drug Products - Product Quality Tests" published for Comments

Since the beginning of May 2023, the chapter <2> Oral "Drug Products - Product Quality Tests", which is part of the heading "General Tests & Assays", has been published for comments on the website of the Pharmacopeial Forum of the USP. Comments and remarks on this draft, which is based on the previous version from August 2020, can be submitted until 31 July 2023.

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