GMP News - Quality Assurance

09.08.23

Identity Testing of Glycerin in Focus of an FDA Warning Letter

At the beginning of August, the U.S. Food and Drug Administration (FDA) has published a new Warning Letter. As in several cases in recent months, it is again about a US manufacturer who failed to conduct proper identity testing of glycerin and other high-risk components. In addition, a number of other CGMP violations are documented.

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09.08.23

EDQM: Nitrosamines and CEPs

As recently reported in our News, the 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" has been updated again. The EDQM has now defined the resulting measures for CEP holders and listed them in its Newsroom.

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09.08.23

FDA's Draft Guidance on Postmarketing Noncompliance

The agency issued a draft guidance providing information for marketing authorization holders of human prescription drugs who are required to conduct postmarketing studies or clinical trials, commonly referred to as postmarketing requirements (PMRs). In case of PMR Noncompliance the MAH could be subject to an FDA warning letter.

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02.08.23

MRA between Switzerland and the USA now effective

The Mutual Recognition Agreement (MRA) between Switzerland and the United States in the area of GMP for medicinal products has entered into force. It applies to both human and veterinary medicinal products.

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02.08.23

EU-GMP Chapter 7: Is a "Chain of Contracts" allowed?

The EMA has updated its Questions and Answers and discusses where and when "Chain of Contracts" are accepted and which principles should be adhered to.

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02.08.23

The New Annex to EMA's Question and Answer Document on the Determination of Acceptable Intake Levels of Nitrosamines

EMA's Q&A document has been extensively revised and supplemented with regard to the limits for nitrosamine impurities. The new Annex 2 describes the approach for determining acceptable intake levels for nitrosamines without data from in vivo mutagenicity studies.

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26.07.23

FDA criticised over inadequate GMP Inspections in India and China

Republican Congress members are worried that the US is overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA regulations and express this in a letter to the FDA Commissioner.

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26.07.23

EDQM: Excipient Monographs

Supplement 11.2 to the European Pharmacopoeia (Ph.Eur.) came into force on 01 July 2023 and contains several updated monographs. These include five updated excipient monographs, which now include the so-called "functionality-related characteristics (FRCs)" section. In total, there are now more than 100 Ph.Eur. Monographs that include this section.

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26.07.23

FDA Warning Letter: Using non-validated and not appropriate Test Methods from an Internet Search is not a good Idea

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter. The company in question manufactures over-the-counter (OTC) topical drug products, e.g. antibacterial hand soaps and hand sanitizers. The list of GMP violations is quite extensive and concerns, among others, QU oversight, handling of out-of-specification (OOS) results, identity testing, and laboratory controls in general.

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26.07.23

New in the ECA Members Area: "QA Responsibilities" in the Mirror of Warning Letters

The FDA's Warning Letters contain detailed descriptions of GMP deficiencies and thus provide a useful perspective in the context of preparing for an FDA inspection. In the members' area of the ECA Academy website, topic-focused descriptions of these GMP deficiencies are available, e.g. a compilation on GMP violations in the area of quality assurance.

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25.07.23

CEP 2.0: Insights into Inspection Reports

As part of the implementation of the new "CEP 2.0", the EDQM has now published on its website a list of authorities and organizations that have insight into inspection and assessment reports.

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25.07.23

EDQM: Policy for CEP Applications published for Comments

In June, the draft Certification Policy Document PA/PH/CEP(04) 1, 6R "Content of the dossier for CEP applications for chemical purity and microbiological quality of substances for pharmaceutical use" was published on the EDQM website for comments. Comments and remarks on this draft can be submitted until 15 September 2023.

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19.07.23

COVID-19 Flexibilities also to be terminated in the GMP/GDP Environment

The EU is phasing out the extraordinary regulatory flexibilities for medicines that were put in place during the COVID-19 pandemic to help address regulatory and supply challenges arising from the pandemic. This includes regulatory procedures, manufacturing and importation of APIs and finished products and other requirements.

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19.07.23

EU-GMP: Is remote QP Batch Certification/Confirmation allowed?

The EMA has published new questions and answers on remote batch certification/ confirmation by the Qualified Person (QP). When allowed by the competent authority, clear expectations are defined.

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19.07.23

FDA Warning Letter issued due to no response

In June 2023, the U.S. FDA issued a Warning Letter to the Chinese company "Chengdu KeCheng Fine Chemicals Co., Ltd.". According to the Warning Letter, the company is registered within the USA as an API manufacturing facility, which shipped APIs to the U.S. several times.

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