FDA Warning Letter: Missing Qualification of Contract Labs for Release
In June 2022, the U.S. FDA issued a Warning Letter tto the Dutch company "Fagron Group B.V." after having inspected their US American site "Fagron Inc." in November 2021.
FDA Warning Letter: Benzene Contamination in Hand Sanitizer
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a South Korean manufacturer of OTC drug products. During an FDA laboratory testing of a batch of hand sanitizer, the impurity benzene at unacceptable levels was found. After a review of records and other information provided by the manufacturer, the FDA came to the conclusion that the quality assurance within the facility is not functioning in accordance with CGMP requirements.
Following the previously published list of documents needed during GCP inspections, the EMA issued a set of updated documents on planning and conducting GCP inspections on its website. The annexes compile specific items that may be verified at the sponsor / CRO / investigator site and clinical laboratories.
The EFPIA has published its "Annual Regulatory GMP/GDP Inspection Survey 2021 Data". With some interesting results that perhaps not everyone would have expected.
In a Warning Letter addressed to a US-American pharmaceutical manufacturer, the FDA points out various deficiencies in aseptic production. Among other things, deficiencies are described in the design of equipment and rooms, airflow and visual inspection.
MHRA introduces external consultants as Compliance Monitors in Companies
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a pilot project for a new Compliance Monitor Process. External consultants are being used for this purpose.
Accuracy, Specificity and Reproducibility of Analytical Test Methods in the Focus of a FDA Warning Letter
The U.S. Food and Drug Administration (FDA) has issued a warning letter to an American manufacturer of OTC drug products. Among others, the analytical test methods had not been validated for accuracy, specificity, and reproducibility. Further violations concern the process validation and OOS investigations.
FDA plans Rating System for pharmaceutical Companies
The FDA is planning a programme to assess and classify manufacturing sites using surveillance data and company participation. A central point here is also the so-called Quality Culture.
FDA Warning Letter: Deviation from USP Compendial Methods
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to an American manufacturer. The firm produces a United States Pharmacopeia (USP) article. The core problem was that the company deviated from the USP for analytical testing, but could not adequately demonstrate that the method is equivalent or better than the current USP compendial method.
The EMA published guidance for applicants / MAHs involved in GCP inspections. It includes a detailed list of documents to be provided to GCP inspectors.
How many FDA inspections still take place in the EU?
Do you know the FDA Data Dashboard? This database offers comprehensive and detailed insights into FDA inspections - right down to the inspection history of individual companies.
Numerous GMP Deficiencies at OTC Manufacturer in Puerto Rico
The USA FDA has issued a Warning Letter to a pharmaceutical manufacturer for failing to adequately address numerous deficiencies identified during an inspection.
News on the various Mutual Recognition Agreements (MRAs)
The new annual report of the GMP/GDP Inspectors Working Group has been published and gives a brief but good overview of what is new in 2021. There has also been movement on the MRA with the USA.