EMEA Analyses Quality Defects in Centrally Authorised Products

GMP News
23 May 2007

EMEA Analyses Quality Defects in Centrally Authorised Products

For the first time the European Medicines Agency (EMEA) analysed quality defects for human and veterinary medicinal product authorised in the centralised procedure. A report published in January summarises the results from the year 2005. According to this report the EMEA received 65 notices from manufacturers, marketing authorisation holders (MAH) and authorities. In 20 cases these defects resulted in product recalls.

Corresponding to an internationally accepted standard the recalled products were classified into three classes, as the following table indicates:

Type of Recall Number Incidence in %
Class 1 2 10
Class 2 4 20
Class 3 14 70

"Class 1" identifies recalls of products with defects that are life threatening or represent a serious risk to health. "Class 2" recalls combines products with quality defects that are not necessarily life threatening, but could be hazardous for patients or animals. "Class 3" indicates product recalls for reasons of non-compliance with the marketing authorisation or specification.

In an additional evaluation the defects were assigned to various categories. According to that evaluation two thirds of the quality defects were related to Product Information Literature (package leaflet or outer package) (23.1%), deviations of the marketing authorisation (15.4%), ancillary materials (especially packaging materials) (13.8%) as well as OOS results (12.3%). "Microbiological Cross-contamination" and serious "GMP Inspection Findings" were the reasons for the two "Class 1" recalls.

No Category Number Incidence
in %
1 Product Information Literature 14 23,1
2 Deviation from MA 10 15,4
3 Ancillary Materials 9 13,8
4 OOS 8 12,3
5 GMP Inspection Findings 4 6,2
6 Coring Problems 4 6,2
7 Parallel Distribution 3 4,6
8 Chemical Cross-contamination 2 3,1
9 Dissolution Test 2 3,1
10 OMCL OOS 2 3,1
11 Pharmacovigilance 1 1,5
12 FDA Warning Letter 1 1,5
13 Handling Error 1 1,5
14 Stability Testing 1 1,5
15 Sterility Assurance 1 1,5
16 Microbiological Cross-contamination 1 1,5
17 Counterfeit 0 0,0

The results clearly show that it is worth focusing more on labelling, packaging, release procedures and processes during GMP inspections. For instance, a wrong product information literature ruins all efforts in upstream production processes and possibly leads authorities to recall a product although it is actually safe and of good quality.

The analysis provides a good overview over the most important quality defects reported and complements similar analyses from other authorities. For inspectors, national authorities, manufacturers as well as for MAHs it can also be a big help for identifying areas with room for improvement.

Prepared by:
Wolfgang Heimes
On behalf of the European Compliance Academy (ECA)

Resource: http://www.emea.europa.eu/Inspections/docs/2302007en.pdf

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