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Glossary entry

Italian term or phrase:

DP

English translation:

Drug Product

Added to glossary by Luigi Argentino
Oct 31, 2019 14:43
4 yrs ago
6 viewers *
Italian term

DP

Italian to English Medical Medical: Pharmaceuticals qualified person's (QP) declaration concerning good manufacturing practice compliance of active substance manufacture
ds is drug substance i think, what might DP be?
App.9 (Vers. 1.3 datata 08.10.2019)
Per la sperimentazione clinica in oggetto è stata presentata una richiesta di Emendamento Sostanziale “Brexit QP declaration per il nuovo sito”. Dopo una prima valutazione erano emerse delle richieste alle quali il Promotore ha risposto inviando le seguenti QP declaration:
- Em004 QP declaration for PF-06804103 2017-002538-22 C0541001 dated 14-Aug-2019 (GC).docx_1
- Em004 QP declaration for PF-06804103 2017-002538-22 C0541001 dated 14-Aug-2019 (SW).docx
- Em004 QP Declaration for PF-06804103 2017-002538-22 C0541001 DS dated 14-Aug-2019 (GC).docx
- Em004 QP Declaration for PF-06804103 2017-002538-22 C0541001 DS dated 14-Aug-2019 (SW).docx
Come richiesto in fase di valutazione, il Promotore ha fornito nuove QP declaration sottoscritte dalle QP del sito UK Pfizer Limited Sandwich con il MIA (IMP) 57 e del nuovo sito irlandese Pfizer Grange Castle con il MIA IMP115100, indicato come responsabile del rilascio dei lotti dopo la Brexit.
Ai fini della richiesta di emendamento in oggetto la documentazione presentata è accettabile.
Tuttavia, si richiama l’attenzione dell’Autorità competente, poiché il Promotore ha presentato oltre alla documentazione in risposta alle richieste sollevate, la seguente documentazione aggiuntiva:
- S.2 MANUFACTURE – PF-06758921 (PT-183/290) per il prodotto intermedio
- S.2. MANUFACTURE per la DS
- P.3. MANUFACTURE per il DP.
Proposed translations (English)
3 +1 Drug Product
Change log

Nov 5, 2019 08:37: Luigi Argentino Created KOG entry

Discussion

Luigi Argentino Oct 31, 2019:
The question is correct but it should be asked to the person who wrote the text
Lara Barnett Oct 31, 2019:
F vs M But if they are English they would both take masculine anyway wouldn't they?
Luigi Argentino Oct 31, 2019:
Concordo: la sostanza, il prodotto
garrett higgins (asker) Oct 31, 2019:
la sostanza, il prodotto
Lara Barnett Oct 31, 2019:
DS / DP DS is feminine and DP is masculine, so they can't both be Drug can they, or they can't both be the same language maybe.
philgoddard Oct 31, 2019:
It's probably English. All the other abbreviations are.

Proposed translations

+1
9 mins
Selected

Drug Product

A suggestion. I'm looking for the references

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Note added at 11 mins (2019-10-31 14:55:21 GMT)
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Here it is:
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&c...

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Note added at 13 mins (2019-10-31 14:57:25 GMT)
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"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."
Note from asker:
brilliant
Peer comment(s):
agree philgoddard : Well done!
56 mins
Thanks
Something went wrong...
4 KudoZ points awarded for this answer. Comment: "thanks"