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rmdass ☆ 2010-02-18 17:14 (5560 d 05:11 ago) Posting: # 4790 Views: 5,570 |
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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. |
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bharat ☆ India, 2010-03-30 10:00 (5520 d 13:24 ago) (edited on 2010-03-30 10:12) @ rmdass Posting: # 4991 Views: 4,346 |
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Dear Ramdas It will not creat any effect. It is the responsibility of sponsor. you just check the expiry of reference product and the percentage difference in the assay of test product and reference product. i dont think there will be any regualtory impact. If you have any concern pls. revert Regards Bharat Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
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Dr_Dan ★★ Germany, 2010-04-01 16:53 (5518 d 06:31 ago) @ rmdass Posting: # 4994 Views: 4,339 |
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Dear Ramdass I guess the sponsor bought the reference medication and sent one part to you and he kept the other part that was analysed together with the test medication. As long as the retest date of the test product and the expiry date of the reference product cover the time of clinical conduct no problem exists. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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