DP
English translation: Drug Product
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| 14:43 Oct 31, 2019 |
| Italian to English translations [PRO] Medical - Medical: Pharmaceuticals / qualified person's (QP) declaration concerning good manufacturing practice compliance of active substance manufacture | |||||||
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|  Selected response from: Luigi Argentino Italy Local time: 12:29 | ||||||
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| 3 +1 | Drug Product |
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| Discussion entries: 6 | |
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Answers
9 mins confidence: 
peer agreement (net): +1
peer agreement (net): +1Drug Product Explanation: A suggestion. I'm looking for the references -------------------------------------------------- Note added at 11 mins (2019-10-31 14:55:21 GMT) -------------------------------------------------- Here it is: https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&c... -------------------------------------------------- Note added at 13 mins (2019-10-31 14:57:25 GMT) -------------------------------------------------- "For some ATMPs, the starting material, the active substance and the finished product can be closely related or nearly identical. In some cases, an artificial (based on regulatory reasons) distinction between drug substance (DS) and drug product (DP) might be included in the IMPD, but this is not always possible. In general, these distinctions are done based on the individual characteristics of each product. When feasible, the applicant should clearly define in the IMPD what it is considered intermediate products, what is considered drug substance and drug product. Starting from these definitions and based on characterization studies, appropriate in-process and release controls need to be established for each step. It is acknowledged that, depending on the product and on the manufacturing process, and when appropriately justified, release testing of the final product might be performed at earlier stages in the manufacturing process." |
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