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QP declaration

Russian translation: заявление уполномоченного лица [по качеству]

12:30 Dec 24, 2016
English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: QP declaration
Пожалуйста, помогите разобраться QP = qulified person или quality planning.

Manufacturing / Importer Authorisation Holder(s) (MIAHs) to which this QP declaration applies
This QP declaration is applicable to the following registered MIAH(s), that use the active substance as a starting material and/or is responsible for QP certification of the finished batch of a human or veterinary medicinal product, where the active substance is registered as a starting material and is manufactured at the sites listed in Part A:
Basis of QP Declaration of GMP Compliance
QP declaration of GMP compliance
QP Responsibility
I am a QP with specific responsibility for GMP compliance of the active substance manufactured at the sites listed in Part A and I am authorised to make this declaration.
This declaration is made on behalf of all the involved QPs named on the relevant MIAH(s) specified in Part B;
Name and Signature of QP responsible for this Declarati
Maxim Polukhin
Local time: 12:51
Russian translation:заявление уполномоченного лица [по качеству]
Explanation:
Насколько я вижу, здесь везде речь об уполномоченном лице по качеству.

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Note added at 11 mins (2016-12-24 12:41:58 GMT)
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http://www.proz.com/kudoz/english_to_russian/law_contracts/5...

http://www.proz.com/kudoz/english_to_russian/medical_general...

http://www.proz.com/kudoz/english_to_russian/medical_general...
Selected response from:

Evgeni Kushch
Ukraine
Local time: 12:51
Grading comment
Спасибо!
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +2заявление уполномоченного лица [по качеству]
Evgeni Kushch
3декларация уполномоченного лица
FreEditor
Summary of reference entries provided
qualified person’s (QP) declaration
Oleg Nenashev

  

Answers


6 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +2
qp declaration
заявление уполномоченного лица [по качеству]


Explanation:
Насколько я вижу, здесь везде речь об уполномоченном лице по качеству.

--------------------------------------------------
Note added at 11 mins (2016-12-24 12:41:58 GMT)
--------------------------------------------------

http://www.proz.com/kudoz/english_to_russian/law_contracts/5...

http://www.proz.com/kudoz/english_to_russian/medical_general...

http://www.proz.com/kudoz/english_to_russian/medical_general...

Evgeni Kushch
Ukraine
Local time: 12:51
Specializes in field
Native speaker of: Native in RussianRussian, Native in UkrainianUkrainian
PRO pts in category: 981
2 corroborated select projects
in this pair and field What is ProZ.com Project History(SM)?
Grading comment
Спасибо!

Peer comments on this answer (and responses from the answerer)
agree  FreEditor
5 mins
  -> Спасибо, FreEditor!

agree  Natalie
3 hrs
  -> Спасибо, Наталья!
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12 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
qp declaration
декларация уполномоченного лица


Explanation:
Или "заявление уполномоченного лица"

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Note added at 19 mins (2016-12-24 12:50:17 GMT)
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А "QP" расшифровывается как "qualified person": http://www.abbreviations.com/QP


    Reference: http://www.uapf.com.ua/topic865.html
FreEditor
Uzbekistan
Local time: 14:51
Native speaker of: Native in RussianRussian, Native in UzbekUzbek
PRO pts in category: 45
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Reference comments


2 hrs
Reference: qualified person’s (QP) declaration

Reference information:
Template for the qualified person’s (QP) declaration concerning good manufacturing practice compliance of active substance manufacture "The QP declaration template"
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation...
http://www.ema.europa.eu/docs/en_GB/document_library/Regulat...

Oleg Nenashev
Russian Federation
Native speaker of: Native in RussianRussian
PRO pts in category: 48
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