There has been a recent accumulation of Warning Letters from the U.S. Food and Drug Administration (FDA) to manufactures of hand sanitizer products. At the end of November, a further letter was published. In this case, FDA laboratory analyses showed that the ethanol content of several batches was too low. In addition, the FDA has also found numerous GMP violations. There was already a lack of the necessary basic SOPs.
Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. The FDA has now published the data for the fiscal year 2022. Deficiencies in the stability programme in the area of "drugs" were mentioned in numerous FDA 483 forms.
The ECA regularly provides evaluations of the FDA Warning Letters per fiscal year. In 6th place in the fiscal year 2022 (Oct. 2021 - Sept. 2022) are deficiencies regarding the topic of cleaning/cleaning validation. What was found?
The current EU GMP Annex 11 "Computerised Systems" was published in 2011. Due to new technological and regulatory developments, a forthcoming revision of Annex 11 has been discussed for some time. On 16 November 2022, the EMA published a concept paper for public comment. Which points are to be revised?
The U.S. FDA warns five companies for illegally selling food and beverage products containing cannabidiol (CBD). According to the agency, the use of CBD raises safety concerns, especially with long-term use.
In the Pharmacopeial Forum, PF 48(6), a proposal for a revised Chapter <711> Dissolution was published. The purpose of the revision is to replace USP Prednisone Tablets RS with a new Reference Standard, USP Dissolution Performance Verification Standard-Prednisone RS, to qualify the Dissolution Apparatus 1 and Apparatus 2.
The European Medicines Agency has published for public consultation a Good Practice Guide for the use of the Metadata Catalogue of Real-World-Data Sources. The guide provides recommendations on how to use the real-world metadata catalogue that is currently being built and will help to identify suitable RWD sources.
The agency is conducting an Advancing Real-World Evidence Program, which seeks to improve the quality and acceptability of RWE-based approaches in support of new intended labeling claims.
An increasing number of companies with no previous GMP experience are entering the pharmaceutical sector to cultivate, process and manufacture medical cannabis products. Therefore, the MHRA recently posted how the required licences are granted by the agency.
Some authorities within the PIC/S want to mutually recognise GMP inspection reports in order to avoid duplication of work. There is now a corresponding statement on this.