GMP News - Quality Assurance

06.12.23

China tightens Counterespionage Law - Risk for Audits and Inspections?

China has passed a revised counter-espionage law that extends the powers to combat espionage. This increases the legal uncertainty for GMP inspections and audits.

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30.11.23

Swissmedic Clarifies GMP Requirements for Formula Drugs

The Swissmedic recently clarified some requirements for the manufacture and marketing of formula drugs (e.g. "Formula magistralis" medicinal products) by issuing an updated version of their corresponding guidance document. The guideline is the basis for "GMP inspections for formula drugs" carried out by the cantonal inspectorates and Swissmedic.

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29.11.23

FDA Delays Requirements for Cosmetic Facility Registration and Product Listing

The U.S. FDA issued a guidance on the delay of enforcement of the requirements for cosmetic product facility registration and cosmetic product listing under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for six months to help ensure that industry has sufficient time to submit such facility registration and product listing information.

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29.11.23

EMA: Q&A documents on the topic of "Centralised procedures" revised

In September and November 2023, the "Questions & Answers (Q&A)" documents relating to centralised authorisation procedures were revised once again and published on the website of the European Medicines Agency (EMA). The Q&A catalogues, which can be used by marketing authorisation holders and applicants for centralised procedures, provide answers to possible questions at different stages of the centralised marketing authorisation application.

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21.11.23

FDA Warning Letter: Inadequate Quality Systems

The U.S. FDA issued a Warning Letter to the US American company "ALI Pharmaceutical Manufacturing, LLC" after having inspected its site in September/October 2022.

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21.11.23

Supplier Questionnaires and their Way into a FDA 483

A recently published 483 for a sterile manufacturer shows once again that the issue of supplier control is an ongoing concern for the US FDA. However, this is not the only focus in this report, as there are 13 other, sometimes detailed (and hair-raising) observations over 20 pages.

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21.11.23

Revision: FDA Guidance for Remote Evaluations

More than two years ago, the FDA published a Guidance for Industry on remote evaluations: "Remote Interactive Evaluations". Now the successor has been published as a draft. Not much has changed, except for one important innovation.

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21.11.23

News on CEP 2.0: Specifications

The EDQM has once again published further information on its website with regard to the "CEP 2.0". The presentation and content of section 3.2.S.4.1 Specification are now discussed and explained.

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21.11.23

EDQM: Supplement 11.4 to the European Pharmacopoeia available

The supplement 11.4 to the European Pharmacopoeia (Ph.Eur.) is now available and will be implemented on the 1st of April 2024. According to the EDQM timetable, this supplement will be followed by versions 11.5 to 11.8, with the final implementation date planned for July 2025.

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14.11.23

EMA publishes "Toolkit" for Shortages of Medicinal Products

The European Medicines Agency EMA has published a so called "MSSG Toolkit on recommendations on tackling shortages of medicinal products", a guidance document to facilitate identification of recommendations on critical shortages of medicinal products.

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08.11.23

USP: Chapter "<621> Chromatography" published for Comments

Since the beginning of November, the updated version of chapter "<621> Chromatography" has been available on the USP Pharmacopeial Forum website and published for comment. Comments on this draft, which is based on the previous version from October 2023, can be submitted until 31 January 2024.

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02.11.23

EU Commission: Strategy Paper with Measures against Medicine Supply Shortages

The European Commission has adopted a package of measures to prevent and mitigate shortages of critical medicines in the EU in the near future. This "set of actions" now presented complements the reform of the pharmaceutical legislation.

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02.11.23

Warning Letter to Swiss Manufacturer of Homeopathic Eye Drops

Among other things, a Swiss pharmaceutical manufacturer received a Warning Letter from the FDA due to inadequate 100% visual inspection of its eye preparations. But the conduct of media fills and the completeness of laboratory results were criticised as well.

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26.10.23

Quality Attributes for Ophthalmic Drug Products

The FDA published a draft guidance that discusses quality considerations for ophthalmic drug products (i.e., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye.

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25.10.23

FDA Warning Letter for South Korean Manufacturer: Identity Testing, QU Oversight, Equipment Qualification and Maintenance

The U.S. Food and Drug Administration (FDA) has sent a new Warning Letter to a manufacturer located in South Korea. The firm manufactures over-the-counter (OTC) topical drug products, such as hand sanitizers. During an inspection, significant violations of Current Good Manufacturing Practice (CGMP) were found.

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