Categories of inspection findings

Classification of inspection findings: how many categories of inspection findings are there?

Hi. Nha. when audit or inspection have 3 categories are critical, major anh minor faul.
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Hi Nha,
In general, Audit observations are classifed by referening two regulatory agency, wherein as per MHRA the classification of audits to be made as Critical, Major, Minor and Recommendations/Others whereas any non-conformance observed by USFDA is reported as 483s (refer http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm096015.htm)
In general now-a-days regulatory agencies are avoiding giving any recommendations and suggestions however any discussion during the closeout meeting of any inspections site should scribe all those recommendations and suggestion for improvement (which may not be part of final audit report).

For more information you may read this auditing guide for more knowledge on auditing practices and refer section 6.3.4 for classification
http://www.gmp-compliance.org/guidemgr/files/APIC%20CEFIC%20AUDITING%20GUIDE%20AUGUST%202010.PDF

Hope I answer your query.


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