GMP News

On 09 April 2024, a new FDA Form 483 to a company in India was published. The document lists a total of 10 observations made by the FDA investigators during the inspection in March 2024 of the firm's facility located in Baddi.

In April 2024, the U.S. FDA issued a Warning Letter on its webpage to the Australian company "Antaria Pty. Ltd." after having inspected its site in November 2023. According to the Warning Letter the company missed to have an appropriate stability program for its API in place.

Did you know that EMA's Questions and Answers Section to Annex 16 further clarifies the role of the QP in the context of handling unexpected deviations?

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.

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 ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs)” reached Step 2b of the ICH Process in February 2024 and entered the consultation period.

The MHRA published guidance updates on how to notify the MHRA about changes to the Pharmacovigilance (PV) system. The revisions came into effect on 11 May 2023 and have been updated on 17 November 2023.

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 FDA's current approach to monitoring pharmaceutical manufacturing emphasises the importance of quality metrics in ensuring product safety and efficacy. What is behind this?

In Pharma Europe, the publication of a draft of the new chapter "2.6.41 High-throughput sequencing for the detection of viral extraneous agents" represents a step forward in two important areas. Firstly, with regard to the viral safety of medicinal products and secondly, with regard to the regulatory establishment of modern detection methods.

The German federal states have cleared the way for the legalization of cannabis. The law came into force as planned on 1 April. What will change for medical Cannabis?

The revision 1 of the document "Quality overall summary (QOS) template for CEP applications", which was updated in January, has been published on the EDQM website. The document was first published in 2015 and is intended to provide assistance for CEP applicants.