GMP News - APIs and Excipients

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.

more

29.11.23

FDA Warning Letter: Lack of Identity Testing and Stability Program

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.

more

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.

more

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.

more

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.

more

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.

more

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.

more

19.10.23

GDP-compliant Transport of APIs: What needs to be considered?

GDP is not limited to pharmaceuticals. Rather, GDP starts earlier, namely with the transport of the active pharmaceutical ingredients (APIs) used for production. But what general requirements actually apply to the GDP-compliant transport of active ingredients for medicinal products for human use or veterinary medicinal products?

more

10.10.23

USP HMC publishes revised Cannabis Draft Monograph

The USP Herbal Medicines Compendium (HMC) published a revised version of the previously proposed Cannabis Species Inflorescence monograph. In particular, the Content of Terpenes section has been removed from Specific Tests because there is insufficient information to support the use of terpenes for medical purposes.

more

10.10.23

German Federal Cabinet passes Cannabis Act

The German Federal Cabinet has adopted the draft of an "Act on the Controlled Use of Cannabis and on the Amendment of Further Regulations" (Cannabis Law - CanG).

more

10.10.23

EDQM pre-publishes Ph. Eur. Cannabis Flower Monograph

As previously announced the new Ph. Eur. monograph Cannabis flower was adopted and will be published in Ph. Eur. Supplement 11.5 in January 2024. Now, the Ph. Eur. decided to make the monograph immediately available on the EDQM website for information.

more

05.10.23

EMA: Updates in the Product Lifecycle Management (PLM) Portal

New and revised guidance documents and materials related to ePI (electronic Product Information) are now available on the EMA website under the heading "What's New in PLM?" in the PLM Portal (Product Lifecycle Management Portal).

more

05.10.23

EDQM: CEP 2.0 implemented

Since beginning of September 2023, the CEP 2.0 is implemented by the EDQM (European Directorate for the Quality of Medicines & HealthCare). From now on, applicants of a new dossier or renewals will receive a CEP 2.0. This will be available as a PDF file in the so called sharing tool "DCEP" and will be signed electronically only.

more

04.10.23

USP: Excipient Stimuli published for Comments

In the beginning of September, the stimuli document "Proposed Definitions of Excipient Components- Revisions to 2018 Definitions- PF 49(5)" was published for comment on the website of the Pharmacopeial Forum of the USP. Comments on this draft can be submitted until 30 November 2023.

more

04.10.23

FDA Warning Letter for OTC Manufacturer in Arizona

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a U.S. OTC manufacturer. During an inspection, several CGMP violations were found.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics