GMP News - APIs and Excipients

15.04.24

FDA sends Warning Letter to Canadian OTC Manufacturer

A manufacturer of over-the-counter (OTC) drug products based in Canada received a Warning Letter from the U.S. Food and Drug Administration (FDA) regarding significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.

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10.04.24

APIC: Best Practices Guide for dealing with Suppliers

The "Best practices guide for managing suppliers of API manufacturers" was finalised by the "APIC Supplier Management Task Force" in March 2024 and is now available on the APIC website. It emerged from the document "Supplier Qualification and Management Guideline", which was first published in 2009, and now replaces it in its entirety.

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10.04.24

US FDA: Draft on Data Integrity for BE/BA Studies published

At the beginning of April 2024, the draft document "Data Integrity for In Vivo Bioavailability and Bioequivalence Studies" was published on the US FDA website and is now available for comment for 60 days. The document is intended to assist applicants and marketing authorisation holders in the area of data integrity for the clinical and bioanalytical part of bioequivalence and bioavailability studies.

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03.04.24

Warning Letter to Chinese OTC Manufacturer: Violations concerning Identity Testing, Stability Program and Quality Unit

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a Chinese manufacturer of over-the-counter (OTC) drug products. The violations were identified during the FDA's review of records submitted by the company in response to an official request.

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03.04.24

German Federal Council approves Cannabis Law

The German federal states have cleared the way for the legalization of cannabis. The law came into force as planned on 1 April. What will change for medical Cannabis?

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03.04.24

EDQM: Updated Information on the Quality Overall Summary (Module 2)

The revision 1 of the document "Quality overall summary (QOS) template for CEP applications", which was updated in January, has been published on the EDQM website. The document was first published in 2015 and is intended to provide assistance for CEP applicants.

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27.03.24

APIC Quality Agreement Guideline: Update published

The first version of the document "Quality Agreement Guideline & Template" was published in 2009, updated in 2017 and has now been revised again. Version 3 of the guideline was published in January 2024 and is now available on the APIC website in the "Publications" tab.

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27.03.24

Court Ruling: Suspended Sentence and Heavy Fine for Falsifying Stability Data

A court in the UK has sentenced a pharmaceutical company and its former director to heavy fines. The defendant had admitted to knowingly submitting falsified stability data to the MHRA in order to obtain a Marketing Authorization for a product. This was preceded by years of investigation by the authority.

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19.03.24

FDA Warning Letter to Drug Manufacturing Facility in Thailand

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a drug manufacturing facility in Thailand. The violations include failure to conduct appropriate laboratory testing for identity and strength of active ingredients prior to release and distribution.

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19.03.24

EMA/CMDh: Appendix 1 for Nitrosamines Updated Again

The nitrosamine Q&A document "Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products" of the EMA/CMDh contains three annexes (Appendix 1-3) in its current version of October 2023. In February 2024, Appendix 1 was updated again and fifteen new substances were added.

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13.03.24

APIs in Brazil: how to register and obtain the GMP certificate

In February 2024, the ECA offered the Live Online Training "How to register APIs in Brazil - Focus on CADIFA and obtaining a Brazilian GMP certificate". During the Q&A sessions, many interesting questions were posed to the speakers' team. A list of useful abbreviations and definitions in regard on the Brazilian registration system are collected and provided in the following.

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13.03.24

EDQM: Top Ten Deficiencies for CEPs

In February 2024, the EDQM has published its summary of the top ten deficiencies which occurred during the evaluations of the CEPs in 2023. This document called "TOP TEN DEFICIENCIES in New Applications for Certificates of Suitability for chemical purity" should help applicants to avoid such deficiencies in future and lists in detail the findings and its respective sections.

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12.03.24

How does GMP apply for Herbal Medicinal Products?

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.

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12.03.24

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.

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06.03.24

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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