GMP News - Inspections/Audits

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.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has recently published a post on temporary changes in Good Distribution Practice (GDP) in the MHRA Inspectorate Blog.

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 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 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.

Because of the Corona crisis, the fact that an auditor has to visit a site currently presents a potential risk to all persons involved or might simply not be possible because of travel bans. What are the options now?