Analyses of Defect Reports by Ireland’s IMB and FDA Highlight Packaging and Labeling as Key Pharma Manufacturing Problem Area

Analyses by the Irish Medicines Board (IMB) and FDA of their data on deviation reporting over the past few years indicate the prominence of packaging and labeling as a problem area in the pharmaceutical manufacturing arena.

A recent analysis conducted by IMB found that over one-quarter of all deviations reported to the agency between 2008 and 2011 involved packaging and labeling.

Beginning in 2011, the agency split its “packaging and labeling” category into two – “printed text error” and “packaging components” – to hone in better on the root causes.  The two new categories were each responsible for over 10% of deviations reported that year – coming in at second and third place on the top ten list – and taken together would have remained the top category as per the 2008-2010 period.

IMB has also been including as a separate category “product mix-ups” – responsible for 6% of the quality defects in 2011, making it eighth on the top-ten list.

In addition, IMB’s analysis of the causes of contamination reports – the leading category in its 2011 breakdown – has found that a significant percentage of these involve packaging problems.

FDA’s analysis of field alert reports (FARs) and recalls shows a similar prominence of packaging and labeling problems.

For example, 333 of 1112, or about 30% of recalls of tablet products listed by FDA between 2008 and 2012 involved label mix-ups, incorrect packaging or incorrect product insert.

In 2012, labeling problems were the third leading cause for recalls overall, accounting for 48 products being called back from the market, according to FDA data.  Two other categories falling into the packaging/labeling arena, “presence of foreign tablets” and “defective containers,” were responsible for 18 and 12 recalls, respectively, in the FDA tally.

At a December 2012 conference cosponsored by PDA and EMA in Cascais, Portugal, IMB Quality Defect & Recall Manager Aoife Farrell discussed the trends her agency is seeing in its analysis of quality defects reported to IMB, which increased steadily between 2008 and 2011.

Farrell focused, in particular, on the top three quality defect categories in 2011 and also addressed the marketing authorization (MA) non-compliance category – the sixth leading category on the defect report list.  Her discussion included recommendations to manufacturers on how to reduce defects in the areas she addressed (Farrell’s complete remarks are provided below).

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