The FDA has recently issued a Warning Letter to a large Indian pharmaceutical manufacturer following an inspection that revealed poor cleaning and later detected cross-contamination in manufactured tablets. Further GMP violations were detected like leaking HEPA filters and inadequate smoke studies in the sterile area.
EMA, EC and HMA have created a Q&A document on regulatory expectations during the covid-19 pandemic. New questions and answers are dealing with remote audits and remote release.
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Romania-based manufacturer of an unapproved new drug due to, among others, releasing drug products without conducting identity and strength testing.
The European Commission has published Version 17 of the "Questions & Answers regarding the implementation of the rule on safety features for medicinal products for human use".
In the context of process validation, the FDA attaches considerable importance to a "state of control". The FDA expects evidence of this "state of control" as part of stage 3 "continued process verification" within the validation lifecycle. Now, what exactly does the FDA want to see? Parts of the answer to this question can be found in Warning Letters.
The UK MHRA has published a Guidance for exceptional GMP flexibilities for medicines imported from third countries during the coronavirus (COVID-19) outbreak. This additional flexibility might sound reasonable but it will put a lot of additional responsibility on the QPs.
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Danish drugmaker for serious GMP violations, including inadequate testing of finished products. Furthermore, the company failed to conduct at least one test to verify the identity of each component of a drug product.
A Chinese manufacturer has received a Warning Letter from the US-American FDA due to inadequate equipment design, deficiencies in monitoring and not performed laboratory tests as well as deficiencies in the Batch Record Review.
A US-American pharmaceutical manufacturer of OTC solutions and suppositories has received a Warning Letter from the US-American FDA due to non-executed repairs and deficiencies in cleaning and laboratory testing.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a list of temporary regulatory flexibilities on good distribution practices (GDP) that will be allowed to address the current exceptional circumstances during the coronavirus (COVID-19) outbreak.