Pharmaceutical Engineering in the Focus of EMEA Inspections

GMP News No. 900: Pharmaceutical Engineering in the Focus of European Inspections

GMP News
8 March 2007

Pharmaceutical Engineering in the Focus of EMEA Inspections

As we already informed you in our GMP News of 21 February 2007, not long ago the European Medicines Agency (EMEA) published a study statistically evaluating the GMP deficiencies found during inspections.

The evaluation was based on 435 inspections conducted between 1995 and 2005 on behalf of EMEA. The total number of 9465 GMP deviations was found. 193 (2%) of them were considered as critical, 989 (10%) as major and 8283 (88%) as "other significant deficiencies". Critical deviations were found in a higher proportion during product-related inspections than during general GMP inspections.

Documentation deficiencies top the list of most frequent citations with 14.1%, followed by deviations in  Design and Maintenance of Premises (6.7%) and Design and Maintenance of Equipment (6.2%). Thus, two of the three most frequent deficiencies concern engineering.

A similar picture emerges when the GMP deviations are sorted by their significance. Deficiencies regarding design were cited very frequently here, too. The top offender among the critical deviations is the category Design and Maintenance of Premises, followed by Potential for Microbiological Contamination (rank 2) and for Chemical/Physical Contamination (rank 3). Consequently, the most critical deviations were observed in the field of engineering.

These data are meant to be used by the authorities as an orientation for future inspections and for the training of inspectors in the relevant areas. Furthermore, they can give hints as to the fields which should be included in more detail in a revision of the EC-GMP Guideline.

Comprehensive information can be found in the complete EMEA Report.

Learn more about the regulatory and GMP requirements on engineering and how to avoid inspection findings in the following ECA course:
Pharmaceutical Engineering in Prague, Czech Republic, from 8-11 May 2007

"Pharmaceutical water systems and how to maintain a high quality level" is the first part of the conference Pharmaceutical Water Systems - Key compliance issues, "Rouging and how to avoid it" is the second part. The conference takes place in Madrid, Spain, from 22-23 May 2007.

Dr Robert Eicher
On behalf of the European Compliance Academy (ECA)

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