Top 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter In 2019
We evaluated the U.K. Medicines and Healthcare products Regulatory Agency’s (MHRA) GMP inspection data for 2019, including trends associated with prior years, in Part 1 of this two-part article. We also addressed the critical and major deficiencies and the annexes and chapters with which they are associated. In this part, we take the 10 chapters and annexes with the highest numbers of deficiencies and do a deeper dive into the specifics of each.
In the figures that follow, we identify the paragraphs that were cited most frequently for each of the 10 chapters and annexes identified in Figure 1 of part 1 of this series. For two of these, Chapter 1 and Annex 15, we provide two figures for each because a handful of the paragraphs dominate the deficiencies in those areas. The following figures include
Do These Recent Drug GMP Warning Letters Signal A Shift In FDA Enforcement Focus?
The FDA’s posting of drug GMP warning letters citing product adulteration has substantially decreased in the past several months. Warning letters are generally issued approximately seven months after inspections. The decrease we are now seeing is due to the slowdown of on-site inspections with COVID travel limitations and concerns regarding investigator safety.
However, the FDA recently posted two unique warning letters that all pharmaceutical and API firms, regardless of their product category, should consider and evaluate. These first-of-a-kind warning letters often signal a new enforcement focus or process for the FDA. (For example, when the FDA issued a warning letter to McKesson Corp. in Feb. 2019, it was the first and so far, the only time the agency cited failure to comply with the requirements in the November 2013 Drug Supply Chain Security Act (DSCSA) amendments to the Food, Drug, and C
An Analysis Of MHRA s Latest Annual GMP Inspection Deficiencies Report
The U.K.’s Medicines and Healthcare products Regulatory Agency (
MHRA) has taken a different approach in the publication of the
GMP deficiencies for drug product issued during inspections in 2018 and 2019. In 2015 and 2016, the MHRA provided approximately a 100-slide deck each year with tables, figures, and text from deficiencies against the requirements in the chapters and annexes. No data were formally published for 2017. The MHRA published a 6,200-plus line Excel spreadsheet of its 2018 GMP inspection data so that individuals could parse and present the data according to their needs. Last year we published analysis of the data in a two-part set of articles: “An Analysis Of MHRA s Annual GMP Inspection Deficiencies Report” and “The 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter.”
FDA FY2020 Drug Inspection Observations And Trends
A comprehensive GMP intelligence program includes monitoring health authority enforcement actions. The actions include FDA Form 483s, Establishment Inspection Reports, warning letters, recalls, import alerts, consent decree agreements, MHRA annual summaries of inspection deficiencies, and EU reports of GMDP noncompliance. This article presents the most recent publication of GMP drug inspection data, which address drug inspections conducted in FY2020. We examine data from FY2020 and evaluate five years worth of trends in drug GMP inspection enforcement. For additional data on years before 2016, please refer to the article published last year.
The presentation of some data herein differs from data presented on the FDA website, even though it uses the same raw data. For example, I combine all observation listings that cite 21 CFR 211.42(c) into a single value, rather than identifying them in separate line items with the exact same ci