GMP News

With the development of more and more guidance documents in the field of ATMP, new questions arise. The EMA has therefore published a Q&As paper on the GMP requirements for ATMPs.

In April 2021, the U.S. FDA issued a Warning Letter to a Colombian API manufacturer due to significant violations of cGMP regulations for Active Pharmaceutical Ingredients (APIs).

Last week, the EMA confirmed that the clinical trial EU Portal and Database (Clinical Trial Information System (CTIS)) is now fully functional and on track to go live by 31 January 2022.

The new version of APIC's document "GUIDANCE ON ASPECTS OF CLEANING VALIDATION IN ACTIVE PHARMACEUTICAL INGREDIENT PLANTS" was finalised in February 2021 and is now available.

The Competent Authority of Germany (Bezirksregierung Düsseldorf) has entered a new GPD Non-Compliance Report dated into the EudraGMDP database due to serious GDP violations at a German wholesaler. The case involves trading of falsified medicinal products and storage of expired medicinal products in regular stock. Furthermore, there are doubts on the reliability of the Reponsible Person and the CEO due to an ongoing criminal procedure.

Teleconferencing, livestreaming sessions and screen-sharing technologies will be used by the FDA in future remote evaluations- but these remote evaluations will not be considered inspections.

On 17 March 2021, the Delegated Regulation (EU) 2021/457 was published in the Official Journal of the European Union. It amends the Delegated Regulation 2016/161 regarding an exemption from the obligation for wholesalers to decommission the unique identifier (UI) of medicinal products exported to the UK.

A blog of the MHRA allows interesting insights into the current inspection practice of the authority and describes advantages and disadvantages of distant assessments.

The U.S. Food and Drug Administration (FDA) recently published a Warning Letter to a Mexican firm whose facility is registered as a manufacturer of over-the-counter (OTC) drug products in the United States. The Warning Letter is not based on inspection findings from an onsite audit but on the review of documents that the company was required to send at the request of the FDA. The FDA found different serious deficiencies based on the submitted documents.

In March 2021, the U.S. FDA issued a Warning Letter to a Chinese manufacturer of over-the-counter (OTC) drug products called "Foshan Biours Biosciences Co., Ltd." due to significant violations of cGMP regulations for finished pharmaceuticals.

USP´s Packaging and Distribution Joint Subcommittee posted a proposal for the development of a new General Chapter <1xxx> Supplier Qualifications.

A letter from the UK government to medicines and medical products suppliers extends the transitional phase for the recognition of EU batch tests beyond 2022.