Sep 4, 2017 02:37
6 yrs ago
13 viewers *
English term

holding of drug product

English to Spanish Medical Medical: Pharmaceuticals
Estoy traduciendo un expediente farmacéutico de unos comprimidos / tabletas proveniente de la India. En la sección de buenas prácticas de manufactura o fabricación dice:

"1. Area and Equipments

The area should be free from unwanted material as well as material from the last batch The equipments to be used should be labeled for product batch no. and date o prior to use.The equipments to be used must bear a “clear equipment’ tag and wash water analysis report releasing the equipment in case of product change over.

II. Personnel

All personnel should be of good health and should practice good sanitation habits.
Persons engaged in the manufacture, processing, packing or **holding of drug product** should bear protective apparent such as head, face, hand and arm covering necessary to protect the product from contamination."

Mil gracias por su ayuda
Proposed translations (Spanish)
3 +8 almacenamiento

Discussion

Charles Davis Sep 4, 2017:
Holding = storage/warehousing I thought at first that "holding" might be an error for "handling", which would mean "manipulación", but it isn't. This phrase, "manufacture, processing, packing, or holding of a drug product" (note the article, missing in the ST), occurs in the US Code of Federal Regulations, Title 21 (Food and Drugs)
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFR...

and, more pertinently, in the FDA's GMP (good manufacturing practices) for pharmaceutical products, where the section entitled "Holding and Distribution of APIs and Intermediates" refers to storage and warehousing procedures in relation to "Holding":
http://academy.gmp-compliance.org/guidemgr/files/1-9-2.PDF
(p, 20, p. 24 of file).

So that's definitely what it means.
Joseph Tein Sep 4, 2017:
date o There is also an error here. Either the letter "o" was added accidentally, or possibly they left out "_f expiration". I usually see "batch No." alongside "date of expiration."
David Hollywood Sep 4, 2017:
I agree with Joseph. "equipments" is a big no no in US or UK English to start with and Indian English (while valid) varies significantly from UK/US English
Joseph Tein Sep 4, 2017:
Indian English If your text was written by someone in India, you may have some extra challenges in translating this. Their English is not the same as U.S. or U.K. English and often seems disjointed to me. I can't take it seriously a lot of the time.

We would not say "equipmentS" in real English, for example ... we would say "equipment" (singular). "Should bear protective apparent" contains TWO mistakes ... it should read "should wear protective apparel."

If you find some other wording or sentences a little strange or not quite clear, it's probably not you that's at fault.

Proposed translations

+8
2 hrs
Selected

almacenamiento

It seems to me that "manejo" or "manipulación" are already covered by the word "processing" in the source text; "holding" to me suggests storage ... therefore my suggestion of "almacenamiento" de productos farmacéuticos.

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Note added at 4 hrs (2017-09-04 06:39:30 GMT)
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This is assuming that the word "holding" in the Indian English source is really what they meant to say, and not another mistake (where they intended to say "handling").

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Note added at 3 days1 hr (2017-09-07 04:17:23 GMT) Post-grading
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Glad to help as usual :)
Peer comment(s):

agree Charles Davis : Definitely correct. Reference to follow.
3 hrs
Definitely appreciate your looking into this and confirming.
agree claudia16 (X) : yep
4 hrs
agree abe(L)solano : Por supuesto, mantener los lotes almacenados hasta su liberación ('holding' en oposición a 'release').
5 hrs
agree David Hollywood : great research by Charles and this is it
7 hrs
Thanks David.
agree Giovanni Rengifo
10 hrs
Hi, Giovanni. Thank you.
agree Abel Morales Estrada : Manufacture y processing implican la manipulación del producto. En cambio, en el empaque y el almacenamiento deben contarse con señalamientos para proteger el producto.
10 hrs
agree bizisyl
12 hrs
agree Santiago Gaston Garay : Yes, you and Charles are definitely right.
22 hrs
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4 KudoZ points awarded for this answer. Comment: "Thanks a lot (as usual)"
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