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Dear All,
We have received only reference Product from Sponsor, 3 months back for BABE Study (USFDA). We have received Test product recently and, received COA for the same (including COA for Reference Product) at the same time when we receive the test product. Analysis (COA) has been done on same date for both products (Test & reference). Even though reference product received 3 months back, but analysis (COA) report on current date.
Regulatory Point of view it may create any Impact.
Kindly Explain.
With best Regards,
Ramdass.
We have received only reference Product from Sponsor, 3 months back for BABE Study (USFDA). We have received Test product recently and, received COA for the same (including COA for Reference Product) at the same time when we receive the test product. Analysis (COA) has been done on same date for both products (Test & reference). Even though reference product received 3 months back, but analysis (COA) report on current date.
Regulatory Point of view it may create any Impact.
Kindly Explain.
With best Regards,
Ramdass.
Complete thread:
- COA Reportrmdass 2010-02-18 16:14
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- COA Report Dr_Dan 2010-04-01 14:53
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