GMP NEWS 2024

In the Pharmacopeial Forum, PF 50(1), a new version of USP Chapter <1053> Capillary Electrophoresis was published. Comments can be submitted until 31 March 2024.

Falsified medicines do not meet the standards of safety, efficacy and quality as are required and may pose a serious risk to public and animal health. That is why the topic is explicitly addressed in the EU GDP guidelines. Despite all precautions, several examples have recently come to light in which counterfeit medicines have entered the legal supply chain. 

If the outcome of an inspection is that the wholesale distributor does not comply with Good Distribution Practice (GDP), a statement of non-compliance may be entered into EudraGMDP. As in previous years, we have prepared an overview of the GDP Non-Compliance Reports published in 2023 and the respective reasons for issuing these reports.

Not responding to FDA requests for records related to drug manufacturing and product quality is not a good idea, as can be seen by a recently published Warning Letter.

Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 17: Can an automated deployment chain replace an IQ? If so, what information must the deployment chain provide?

Following the previously issued article on microbial contamination, authors from the FDA recently published an article on elemental impurities in cannabis following vaporization. The results indicate that a transfer of heavy metals from cannabis material to cannabis vapor may not occur during the vaporization process under the applied study conditions.

Combination products (the combination of a medicinal product and a medical device) are increasingly "on the rise". However, the regulation governing these combination products is very complex. For the EU area, the EMA Q&A document Questions & Answers for applicants, marketing authorization holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) provides assistance in this regard.  The document was revised at the end of 2023. What is new?

With the implementation of the Medical Device Regulation (MDR), a "responsible person" according to Article 15 MDR also became mandatory. Minimum requirements for this "person responsible for regulatory compliance" are specified in this article.  Further information can be found in the guideline "MDCG 2019-7", which has now been revised. What are the changes?

In December 2023, the U.S. FDA issued a Warning Letter (WL) to the US American company "Inopak, Ltd." after having inspected its site in July and August 2023. According to U.S. FDA Warning Letter, the firm failed to maintain an ongoing stability program for their drug product.