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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