The number of microbial contamination deficiencies identified by MHRA GMP inspectors doubled in fiscal 2011.
UK Medicines and Healthcare products Regulatory Agency (MHRA) inspectors made 31 observations of microbial contamination last year, up from 15 in 2010. The surge moves microbial contamination into the top three most common production failings found by the MHRA, up from tenth a year ago.
A doubling in the cases of microbial contamination deficiencies identified by MHRA inspectors moves the total for 2011 closer to previous highs. In 2008 and 2009 microbial contamination cases were common, with 49 and 43 observations respectively, but findings of deficiencies slumped a year later.
The slump now looks like a blip. Microbial contamination fell just outside the top 10 most common MHRA observations last year. Ahead of it are two other observations in the ‘production’ category of the classification system – chemical or physical contamination and manufacturing documentation.
Cases of chemical or physical contamination grew by almost one-fifth year-on-year, despite a dip in the number of inspections done by the MHRA. The rise moved chemical or physical contamination into the top ten most common observations made by MHRA inspectors last year.
Examples of contamination observations were given, including: “Air was recirculated from different processing rooms, which could manufacture different products, by one air handling unit. The grade of filters used was less than those expected for such a situation to prevent cross contamination.”
Still number one
The MHRA has posted data on its most common inspection observations since 2007 and each year the same deficiency has topped the chart. This continued in 2011 when failings tied to investigations of anomalies were the most common deficiency yet again.
Numerous examples of these failings are given, including: “A large number of investigations were seen that were not closed in a timely manner or were still open a number of months beyond the stipulated expected closure time”, the MHRA wrote.