We recently reported on the issuance of two FDA Warning Letters, which included observations on inadequate root cause analysis (RCA). However, also in other Warning Letters issued, insufficient root cause analysis is cited and seems to be a frequent finding in FDA inspections.
Recently, several Warning Letters have been published by the US FDA criticising the use of non-dedicated equipment for pharmaceutical and non-pharmaceutical products. In a recent Warning Letter, this is once again made very clear.
In April 2024, the FDA inspected the production facility of a manufacturer in Gujarat, India. Due to several serious GMP violations, the authority has now issued a Warning Letter.
Following the draft paper issued in 2023 the FDA now published the final version of the Question and Answers (Q&A) document on Electronic Systems, Records, and Signatures in Clinical Investigations.
The European Medicines Agency (EMA) has published a new guideline on the quality and equivalence of locally applied, locally acting cutaneous products.
In August, the final guideline ICH E11A Guideline on pediatric extrapolation was published on the ICH website in the efficacy guidelines section. It is seen as a supplement to the guideline ADDENDUM TO ICH E11: CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION E11 (R1) and is due to come into force in January 2025.
How is Artificial IntelligenceI used in equipment qualificattion? This is a question the ECA wanted to clarify with a survey. The survey contained 8 questions. Altogether 60 participants completed the survey. In the following, you will find a summary of the questions asked and their answers.
In October 2024, the Questions & Answers (Q&A) documents relating to centralised marketing authorisation procedures - for topics before and during the application as well as for questions after the granting of marketing authorisation - were again updated and published on the website of the European Medicines Agency (EMA).
In September 2024, the U.S. FDA issued a Warning Letter to the Indian company "MMC Healthcare Ltd." after having inspected its site in March 2024. According to the Warning Letter, the firm failed to have "appropriate controls to assure the integrity of electronic test data, such as an audit trail and defined user access levels".
The U.S. Food and Drug Administration (FDA) has issued a new Warning Letter highlighting critical violations of Current Good Manufacturing Practice (CGMP) regulations, which cover the manufacturing and analytical testing of drug products.