master batch record (MBR)
Russian translation: Сводный протокол сопровождения партии препарата
| 13:44 Apr 10, 2007 |
| English to Russian translations [PRO] Medical - Medical: Pharmaceuticals / GMP | |||||
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|  Selected response from: Alina Barrow France Local time: 03:32 | ||||
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| Summary of answers provided | ||||
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| 4 +1 | мастер паспорт серии |
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| 2 +1 | возможно, контрольный протокол сопровождения |
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| 3 | Сводный протокол сопровождения партии препарата |
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| Summary of reference entries provided | |||
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| Mark Allen Durivage, "The Certified Pharmaceutical GMP Professional Handbook, Second Edition", 2016 |
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Answers
22 mins confidence: 
peer agreement (net): +1
peer agreement (net): +1| master batch record (mbr) возможно, контрольный протокол сопровождения Explanation: или оригинальный, протокол- образец |
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3 hrs confidence: peer agreement (net): +1
peer agreement (net): +1| master batch record (mbr) мастер паспорт серии Explanation: batch record отличает от master batch record тем, что MBR является окончательным описание серии (см. первую ссылку). По аналогии с мастер-файлом, который сохраняют при переводе досье на лекарственный препарат, думаю, следует сохранять слово "мастер" впрямую. По поводу "batch series" - в русской версии английской презентации представителя ВОЗ по контролю качества в GMP фраза переведена как "паспорт серии". (см ссылки в конце) http://dtp.nci.nih.gov/branches/prb/prb_operations.html Clinical Dosage Form Manufacturing All the information generated at the preformulation/formulation development stage is useful at this stage along with analytical reports and validation packages of the bulk drug. After producing one or more pilot batches to establish the manufacturing procedure, a ***master batch record*** is written. All subsequent batches are manufactured according to the master batch record and the product is subjected to QC testing before it is released for packaging and labeling. After the batch is labeled and packaged, the batch record and quality control information is reviewed and approved by the manufacturer's QC/QA departments. ВОЗ mednet3.who.int/prequal/trainingresources/pq_pres/workshop_China2005/M03-QA-doc-1-fC.PPT http://mednet3.who.int/prequal/trainingresources/pq_pres/wor... -------------------------------------------------- Note added at 3 hrs (2007-04-10 17:11:28 GMT) -------------------------------------------------- Наверное, лучше писать "мастер-паспорт серии" batch processing record в том же источнике - документация о прохождении серии batch packaging record - документация об упаковке серии |
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4 hrs confidence:
| master batch record (mbr) Сводный протокол сопровождения партии препарата Explanation: Посмотрите ссылку - документ огромный, лучше задать поиск непосредственно в самом документе "оформление сводного протокола сопровождения партии препарата" Reference: http://www.who.int/vaccines-documents/DocsPDF/www619.pdf |
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Reference comments
3523 days |
| Reference: Mark Allen Durivage, "The Certified Pharmaceutical GMP Professional Handbook, Second Edition", 2016 Reference information: Согласно одной книге ("The Certified Pharmaceutical GMP Professional Handbook, Second Edition", 2016 г) Master Batch Record это некий образец, прототип, его не заполняют (если я понял правильно). Вот ссылка на страницу в Google Books: http://goo.gl/dTvAdz Reference: http://goo.gl/dTvAdz |
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