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View Full Version : Which Date (start/end of analysis) should be considered as Date of analysis?


raghu_1968
24th July 2009, 01:14 AM
During product analysis (API and Solid oral dosage) what date is considered as the “Date of analysis”

Till date what we are following in our organization is “Date of completion of the last analysis of that particular product”

It is being told that, date of analysis should be the “Starting date of the very first analysis of the product”

Now we want to put this in our procedure.

Is there any guideline reference for this?

Note: Date of analysis is part of the Certificate Of Analysis, which is being sent along with the consignment to the customer and regulatory agency.

Regards / Raghu

harry
24th July 2009, 02:33 AM
To my mind, this is a traceability issue (date of analysis). Stick to your convention and be consistent - either starting or end date. This is a common practice and the 'API' industry should not be that different - I may be wrong.

Ajit Basrur
24th July 2009, 12:34 PM
I would go in for "first date" of analysis as after testing, the material would be approved on or later than "end date" :)