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COT-F013 Revision Date: 12/09/2009 COT STANDARD PROCEDURE & FORM JUSTIFICATION Subject: Standard Procedure & Form Recommendation Instructions: Use in conformity with Procedure # COT-013, COT Standard
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COT standard procedure AMP refers to the approved method procedure used for measuring the concentration of active pharmaceutical ingredients in a pharmaceutical product.
Pharmaceutical companies are required to file COT standard procedure AMP for their products.
COT standard procedure AMP can be filled out by following the guidelines provided by the regulatory authority.
The purpose of COT standard procedure AMP is to ensure accurate measurement and reporting of active pharmaceutical ingredient concentration in pharmaceutical products.
COT standard procedure AMP requires reporting of the method used for measuring concentration, equipment used, and the results obtained.
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