In order to be able to continue to provide the population with high-quality, effective and safe medicinal products during the Covid-19 pandemic, Europe is taking exceptional measures. A Q&A document has been prepared in cooperation between the European Commission, the Coordination Group on Mutually Recognised and Decentralised Procedures (CMDh), the Inspectors Working Group and the European Medicines Agency (EMA). At the end of May, special features for process validation (question 6.2) were added under the heading "GMP Flexibilites".
Is there an FDA requirement to perform a success control after GMP training? Actually, the answer is no.
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a US-based drug maker for significant violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, including the failure to investigate out-of-specification (OOS) test results and to follow proper documentation practices.
With the publication of six final guidelines on gene therapies and one additional draft guideline, the FDA is further expanding its activities in the area of advanced therapies.
The MHRA recently shared their expectations regarding electronic systems used in clinical trials and what they want to see during a GCP inspection.
In our News dated 19.08.19, we had mentioned the draft of a new Ph. Eur. chapter (5.28) regarding Multivariate Statistical Process Control. This chapter has now been adopted and will be published in the October 2020 issue.
The U.S. FDA issued a Warning Letter to the US American contract testing laboratory International Trading Pharm Lab Inc due to significant violations of cGMP regulations and the inaccurancy of electronical data for Active Pharmaceutical Ingredients (APIs).
The classification defines, among other points, which kind of GMP certification is needed for export / import of Cannabis Flower to the EU and Germany.
Is there a specific FDA requirement for a Design Qualification? The answer is (actually) No.