GMP News

At the beginning of April, the FDA published a Warning Letter to a manufacturer from South Korea. This contained a whole series of deficiencies, including a lack of validation of manufacturing processes and quality control measures, as well as a lack of testing of ingredients such as glycerine for the absence of ethylene and diethylene glycol.

During an investigation by the FDA, several CGMP violations were identified, which may lead to the denial of importation of drug products into the United States.

In March 2024, the document "Unique identification of manufacturing sites linked to CEP applications, using SPOR OMS and GPS coordinates" was updated and revised and published in revision 4 on the EDQM website in April.

Following the concept paper for updating the GACP guideline, the revised Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin has now been published. The document is open for comments until 15 July 2024.

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?

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?

The ECA Analytical Quality Control Group (AQCG) has developed a new Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation. It is intended to be a practical guide for risk-based instrument qualification and system validation.

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.

A manufacturer of over-the-counter (OTC) drug products based in Canada received a Warning Letter from the U.S. Food and Drug Administration (FDA) regarding significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.

The FDA published a draft guidance on key information in informed consent.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

Almost 100 participants attended the ECA Webinar "GDP Update 2024" in March. Many interesting aspects were discussed in the Q&A session. The speaker, Dr. Christian Grote-Westrick, has answered the questions in writing afterwards. We have compiled a selection of the questions and answers for you. You can read Part 1 here.