GMP News

The FDA published a draft guidance on key information in informed consent. Comments are due by 30 April 2024.

In March 2024, the ECHA (European Chemicals Agency) published the next steps of its working groups with regard to the restriction of "PFAS" (per- and polyfluoroalkyl substances) in Europe on its website.

According to Chapter 6 of the EU GDP Guidelines, all complaints, returns, suspected falsified medicinal products and recalls must be recorded and handled carefully according to written procedures. In this article, you will find a checklist to verify the minimum implementation.

The United States Pharmacopeia (USP) is developing a new General Chapter dedicated to Process Analytical Technology (PAT), aiming to provide guidance on its definition, attributes, enablers, and practical applications in the pharmaceutical industry. Comments on the proposed outline are due to the USP by 28 April 2024.

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.

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.

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.

A sterile manufacturer in Jordan received a Warning Letter from the US FDA for inadequate equipment and facility design as well as other deficiencies.

During an inspection carried out in October 2022, the FDA found unsanitary and dirty conditions at a sterile manufacturer in India, resulting in a Warning Letter.

A recent EU Statement of Non-Compliance with GMP contains significant observations and requires the inspected company to carry out a detailed analysis, particularly with regard to CAPA.

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.

The question of how tight the cleanrooms must be needs to be answered as early as the planning phase of a facility. The DIN EN 15727 standard and the new version of VDI Guideline VDI 2083 Sheet 19 provide assistance. Read more here.