GMP News

The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a OTC drug manufacturer in Mexico. No procedure to handle OOS results was in place, and drug product with OOS results were released and distributed. There was also a lack of stability data and the quality unit did not provide adequate oversight.

The European Medicines Agency added a disclaimer to the Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates to address its applicability regarding the European Clinical Trials Regulation (CTR).

The EMA issued an updated Questions and Answers document with information about the previously announced raw data proof-of-concept (PoC) pilot for industry. Will the Raw Data Analysis lead to more GCP Inspections?

The two proposed USP General Chapters <660> and <661.2> have been published for comment in the current issue of Pharmacopeial Forum. The deadline for comments is May 31, 2023.

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 9: The multi-tenant provision of SAAS is accompanied by a source code basis for all customers. This implies that all customers must have the same software version irrespective of whether or not a customer accepts a certain change. Is this compatible with GxP?

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 8: Which contents must be covered by the service provider's change control and in which way must the contract giver be integrated into this system?

In March 2023, the U.S. FDA issued a Warning Letter to the US American company "Omega Packaging Corp" after having inspected its site in October and November 2022.

The FDA published the final guidance on Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.

The EMA published the final updated EU herbal monograph on Hypericum perforatum L. including associated supporting documents and an overview of the comments received.

In the Pharmacopeial Forum, PF 49(2), a proposal for a revised USP General Chapter <1079.2> "Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products" and a Stimuli Article "The Use of Mean Kinetic Temperature and the Need of Allowable Excursion Limits for Climatic Zone IVb" were published. Comments can be submitted until 31 May 2023.

More than 60 participants attended the ECA Webinar "GDP Update 2023" in March. Many interesting aspects were discussed in the Q&A session. In total, about 20 questions were addressed to the speaker, Dr. Christian Grote-Westrick, which he answered in writing afterwards. We have compiled a selection of the questions and answers for you. You can read Part 1 here.

In pharmaceutical water systems, the TOC value (Total Organic Carbon) is usually determined online. Since bacteria consist mainly of hydrocarbons, the question arises whether TOC monitoring can also provide information about the microbial status of the water system.