Glossary entry (derived from question below)
English term or phrase:
compendial or customer requirements
English answer:
Compendial is abstract and customer is purchaser of services
Added to glossary by
Laura Morarelli
Jul 17, 2005 10:03
18 yrs ago
11 viewers *
English term
compendial or customer requirements
English
Medical
Medical (general)
API Expiry and Retest dating
I've already posted this question on the English to Italian section of Kudoz. Please help me with this translation:
The Certificate should list each test performed in accordance with compendial or customer requirements, including the acceptance limits, and the numerical results obtained (if test results are numerical).
Another sentence (Reserve/ Retention samples of APIs)
Sufficient quantities (of samples od APIs) should be retained to conduct at leaset two full compendial analyses or, when there is no pharmacopeial monograph, two full specification analyses.
In the Italian section two possible translations have been proposed: summary and normative.
Thanks a lot
The Certificate should list each test performed in accordance with compendial or customer requirements, including the acceptance limits, and the numerical results obtained (if test results are numerical).
Another sentence (Reserve/ Retention samples of APIs)
Sufficient quantities (of samples od APIs) should be retained to conduct at leaset two full compendial analyses or, when there is no pharmacopeial monograph, two full specification analyses.
In the Italian section two possible translations have been proposed: summary and normative.
Thanks a lot
Responses
Responses
18 hrs
Selected
Compendial is abstract and customer is purchaser of services
This is the English
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Note added at 18 hrs 8 mins (2005-07-18 04:11:10 GMT)
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and goods
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Note added at 18 hrs 8 mins (2005-07-18 04:11:10 GMT)
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and goods
2 KudoZ points awarded for this answer.
2 hrs
brief; expeditious.
OEd gives Compendious, brief; expeditious as adjective meaning of compendiary, which I believe is an alternative to compendial
17 hrs
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Relaince on Sakhr and Merriam Webster for Compendia
+1
20 hrs
USP (United States Pharmacopoeia) requirements or specific customer requirements
"Compendial" refers to the compendium, which in this case is the USP.
in accordance with compendial requirements = in accordance with the USP (United States Pharmacopoeia) requirements
customer requirements = requirements specified by the customer
United States Pharmacopoeia (USP) Official compendium recognized by the Federal Food, Drug, and cosmetic Act. Serves as the basis for enforcement actions by the U.S. Food and Drug Administration involving official (USP) drugs. Published every five years by the United States Pharmacopoeia Convention, a non-profit organization. It is combined with the National Formulary. The USP is the official pharmacopoeia of the United States and several other countries. http://www.labcompliance.com/glossary/u-z-glossary.htm
The United States Pharmacopeial Convention, Inc. (USPC) is an independent organization that sets the standards for determining the quality of pharmaceutical products marketed in the United States of America. The USPC is responsible for publishing the United States Pharmacopeia (USP), a legally recognized compendium used by the pharmaceutical industry. Established in 1820 as a collection of recipes for pharmacists, the USP has evolved into a collection of test methodologies and associated specifications used primarily by proprietary and generic pharmaceutical manufacturers. These standards govern the quality, strength, purity, and potency of excipients, active pharmaceutical ingredients (APIs), pharmaceutical
dosage forms, and many of the reagents, solutions, and indicators used to test these materials. Because of the extensive industry applicability of USP methods, any pharmaceutical testing laboratory must be capable of using the technologies and performing the procedures described in this world-recognized compendium. http://www.pharmtech.com/pharmtech/article/articleDetail.jsp...
in accordance with compendial requirements = in accordance with the USP (United States Pharmacopoeia) requirements
customer requirements = requirements specified by the customer
United States Pharmacopoeia (USP) Official compendium recognized by the Federal Food, Drug, and cosmetic Act. Serves as the basis for enforcement actions by the U.S. Food and Drug Administration involving official (USP) drugs. Published every five years by the United States Pharmacopoeia Convention, a non-profit organization. It is combined with the National Formulary. The USP is the official pharmacopoeia of the United States and several other countries. http://www.labcompliance.com/glossary/u-z-glossary.htm
The United States Pharmacopeial Convention, Inc. (USPC) is an independent organization that sets the standards for determining the quality of pharmaceutical products marketed in the United States of America. The USPC is responsible for publishing the United States Pharmacopeia (USP), a legally recognized compendium used by the pharmaceutical industry. Established in 1820 as a collection of recipes for pharmacists, the USP has evolved into a collection of test methodologies and associated specifications used primarily by proprietary and generic pharmaceutical manufacturers. These standards govern the quality, strength, purity, and potency of excipients, active pharmaceutical ingredients (APIs), pharmaceutical
dosage forms, and many of the reagents, solutions, and indicators used to test these materials. Because of the extensive industry applicability of USP methods, any pharmaceutical testing laboratory must be capable of using the technologies and performing the procedures described in this world-recognized compendium. http://www.pharmtech.com/pharmtech/article/articleDetail.jsp...
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