Risk Classification of GMP Deviations

GMP News No. 301

GMP-News
4 April 2003
 

Risk Classification of GMP Deviations

 
Pharmaceutical companies, and increasingly also manufacturers of active pharmaceutical ingredients, are subject to supervision by the authorities.

Therefore, observations noted during inspections - including those noted in customer audits - are crucial because the results may, under certain circumstances, have an influence on the economic situation.

Since 1 February 2003, the MRA (Mutual Recognition Agreement) with Canada is in force (see GMP News of 25 February 2003). Hence the GMP systems of Canada and the EC are considered to be comparable, also with regard to their official supervision.

The Canadian supervisory authority (HPFB) has recently published a very interesting draft on the topic of "Risk Classification of Good Manufacturing Practices Observations" on the internet for discussion:
http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/
gui_0023_risk_class_gmp_obs_e.pdf
  
http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/
gui_0023_risk_class_gmp_obs_tc_e.html

The main classification as:

  • Critical observations
  • Major observations
  • Other observations

can be compared to that used in the national inspections by authorities and customers.

However, the Canadians have 3 further risk classes, which then lead to the corresponding observations.

The most interesting thing about this draft is the detailed list of deviations, sorted according to the different GMP areas (premises, equipment, personnel, etc.) and categorised with regard to their risk classes and the resulting observation class.

Author:  
Sven Pommeranz
CONCEPT HEIDELBERG
  

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