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GMP News No. 855
11 December 2006
FDA Criticises Maintenance and Cleaning of Equipment
Maintenance and cleaning of equipment (211.67, Subpart D) is among the top 3 areas for which the US-American health authority FDA issued warning letters in 2006.
The most frequent deficiency that triggered warning letters in the field of equipment in 2006 was insufficient maintenance. Filters gave rise to complaints remarkably often, both in relation to cleanrooms and as regards water equipment. Some of the complaints related to the fact that HEPA filters were not clean, that filters were not changed within the prescribed frequency or that filter integrity tests were not conducted.
Other complaints referred to insufficient cleaning or non-compliance with the required cleaning procedures. The equipment in question were buildings, process, filling or packaging equipment.
Another frequent deviation in the technical field was the missing
qualification of air handling systems for cleanrooms - first and
foremost the lack of proof that no cross-contamination can take place
over the HVAC system.
|If you want to learn more about regulatory requirements, GMP/FDA compliant design, how to handle projects successfully, how to achieve the qualified/validated status and about maintaining it, visit the 4-day GMP education course "Pharmaceutical Engineering" in Prague, Czech Republic, from 8-11 May 2007.|
Dr Robert Eicher
On behalf of ECA