GMP News

The U.S. Food and Drug Administration (FDA) has sent a Warning Letter to a manufacturer of over-the-counter (OTC) drug products. Based on a review of record, the authority found several CGMP violations. These concern inadequate identity testing of incoming components and finished drug products. Furthermore, an adequate stability testing program was not implemented.

The EMA has launched a dedicated website for the Accelerating clinical trials in the European Union (ACT EU) initiative.

Even three months after its entry into force, Annex 1 still raises many questions. Swissmedic has now published a document with technical interpretations of existing questions under the title "Interpretation of GMP Annex 1 2022 (Rev. 1)".

Due to numerous and serious GMP violations in the aseptic area, the FDA issued a Warning Letter to an Indian sterile manufacturer in October. The areas affected include media fills, employee behaviour in the aseptic area, cleanroom & equipment design, environmental monitoring and CAPA.

The final text of the ICH Q2(R2) Revised Guideline on “Validation of Analytical Procedures” and the new Q14 Guideline on “Analytical Procedure Development” were adopted by the ICH Assembly Regulatory Members.

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.

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.

According to Chapter 1 of the EU GDP Guidelines, wholesale distributors must maintain a quality system setting out responsibilities, processes and risk management principles in relation to their activities. In this article, you will find a checklist to verify the minimum implementation.

The ECA Analytical Quality Control Group has extended its Board. Dr Joachim Ermer was invited to join the Board and accepted his nomination.

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.

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.

In October 2023, the Center for Devices and Radiological Health (CDRH) published a list of new guidance documents planned for fiscal year 2024 (1 October 2023 - 30 September 2024), as well as older guidance documents that will be reviewed for current relevance. What new guidelines are coming?