FDA Inspectional Observations on Hygiene, Cleaning and Sanitation

A detailed analysis of the annually published FDA Inspectional Observation Summaries (483s) shows that the topics of hygiene, cleaning and disinfecting are still frequent reasons of deviations. More than 120 entries in the FY 2010 Inspectional Observation Summaries prove that there is a high potential of improvement and optimizing.  

Following a short extract of the 483s overview: 

Ref No Frequency Short description
21 CFR 211.67(a) 61 Cleaning / Sanitizing / Maintenance
21 CFR 211.67(c) 29 Cleaning/maintenance records not kept
21 CFR 211.56(b) 13 Written sanitation procedures lacking
21 CFR 211.56(a) 12 Sanitation--buildings not clean, free of infestation
21 CFR 211.28(a) 4 Clothing appropriate for duties performed
21 CFR 211.42(c)(10)(v) 4 Cleaning System
21 CFR 211.28(b) 3 Habits of good sanitation & health
21 CFR 211.182 12 Personnel  checking the cleaning are not dating/signing equipment log

These results are collected from the summaries part "drugs". Additionally there are hygienic deviations in the parts "Biologicals and "Devices". Especially noticeable is the high number of observations regarding written SOPs or the deficient realisation of their content. Written hygienic plans, including the standard operating procedures and the training of the personnel in their realisation have been required by relevant national Medicines Acts and the international GMP guidelines for a long time, but it appears that the implementation is still a big challenge for the industry. Maybe we can see here too a relation to the insufficient training of the personnel which was critizised by the FDA too (see our news FDA criticises SOP Training in pharmaceutical Companies).

Please see the FY 2010 Inspectional Observational Summaries for further details.

In this regard, please pay attention to ECA's Education Course "Contamination Control" in Budapest, Hungary, from 21-23 March 2012. This course will cover all relevant aspects of hygiene in a pharmaceutical manufacturing site.

Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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