What are API Equipment Cleaning Requirements and Acceptance Criteria?

[Dr. Nirav]

Dear,

Kindly have a idea of the acceptance criteria for holding study of the clean equipment and dirty equipment in API industry?

Is any guideline of FDA for the same?

Please reply if you have any idea.

Thanks

Dr. Nirav

 

[George Weiss]

Greatings from the Elsmar Cove,
A simple Google search of the FDA site, "API filetypdf" found 3 nice guidance materials,
Q7A, and API industry guiance, including equipment cleaning.
http://www.fda.gov/downloads/ICECI/ComplianceManuals/ComplianceProgramManual/ucm125420.pdf
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129098.pdf
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070289.pdf (cleaning on page 8)
Your question suggests you want something more, but I hope this helps.

 

[Ajit Basrur]

Also refer Cleaning Validation Technology for more details on Cleaning Validation requirements.

Note: I do not know Destin but refer this website when ever I have doubts on Cleaning Validation.

 

[Dr. Nirav]

Thanks a lot George for this guidelines but I need the guidance to execute holding study protocol.