put in “ongoing stability 2014”
Russian translation: стали предметом последующих исследований стабильности ЛС после регистрации согласно рекомендациям ВОЗ 2014 года
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| 18:58 Jan 25, 2021 |
| English to Russian translations [PRO] Medical - Medical: Pharmaceuticals | |||||
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|  Selected response from: Oleg Lozinskiy Russian Federation Local time: 21:21 | ||||
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| 1 | стали предметом последующих исследований стабильности ЛС после регистрации согласно рекомендациям... |
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| Может быть, имеется в виду это? |
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Answers
1 hr confidence: 
стали предметом последующих исследований стабильности ЛС после регистрации согласно рекомендациям... Explanation: стали предметом последующих исследований стабильности ЛС после регистрации согласно рекомендациям ВОЗ, опубликованным в 2014 году Если моя догадка, приведенная в 'Reference comments', окажется соответствующей смыслу исходника. -------------------------------------------------- Note added at 2 час (2021-01-25 21:10:24 GMT) -------------------------------------------------- Поскольку, согласно Мультитрану, 'ongoing stability' -> - ongoing stability programme => программа продолжения исследований стабильности (CRINKUM-CRANKUM) - ongoing stability studies => продолжение исследований стабильности после регистрации (CRINKUM-CRANKUM) https://www.multitran.com/m.exe?a=3&sc=53&s=ongoing stabilit... |
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Reference comments
52 mins |
| Reference: Может быть, имеется в виду это? Reference information: WHO Expert Committee on Specifications for Pharmaceutical Preparations 13. Good manufacturing practices for pharmaceutical products: main principles. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations: thirty-seventh report. Geneva: World Health Organization; 2014: Annex 2 (WHO Technical Report Series, No. 986). 2.1.11 Ongoing stability studies The stability of the API should be monitored according to a continuous and appropriate programme that will permit the detection of any stability issue (e.g. changes in levels of degradation products). The purpose of the ongoing stability programme is to monitor the API and to determine that the API remains, and can be expected to remain, within specifications under the storage conditions indicated on the label, within the retest period or shelf life in all future batches. The ongoing stability programme should be described in a written protocol and the results presented in a formal report that should be available on site. The protocol for an ongoing stability programme should extend to the end of the retest period or shelf life and should include, but not be limited to, the following parameters: –– number of batch(es) and different batch sizes, if applicable; –– relevant physical, chemical, microbiological and biological test parameters with acceptance criteria or reference to the attached specifications; –– reference to test methods; –– description of the container-closure system(s); –– testing frequency; –– description of the conditions of storage (standardized conditions for long-term testing as described in these guidelines, and consistent with the API labelling, should be used); –– other applicable parameters specific to the API. At least one production batch per year of API (unless none is produced during that year) should be added to the stability monitoring programme and generally should be tested at least every 6 months in the first year and then annually to confirm the stability (7). In certain situations additional batches should be included in the stability programme and may require more frequent testing. For example, a stability study should be initiated after any significant change or significant deviation of the synthetic route, process or container-closure system that may have an impact upon the stability of the API (refer to section 2.2.12 Variations). Out-of-specification (OOS) results or significant atypical trends should be investigated. Any confirmed significant change or OOS result should be reported immediately to the relevant finished product manufacturer. The possible impact on batches on the market should be considered in consultation with the relevant finished product manufacturers and the competent authorities. A summary of all the data generated, including any interim conclusions on the programme, should be written and maintained and should be available on site. This summary should be subjected to periodic review. https://www.google.ru/url?sa=t&rct=j&q=&esrc=s&source=web&cd... -------------------------------------------------- Note added at 59 мин (2021-01-25 19:58:12 GMT) -------------------------------------------------- Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles1 1 The current document is a revision of WHO Good manufacturing practices for pharmaceutical products: main principles, previously published in WHO Technical Report Series, No. 961, 2011, Annex 3. Stability studies 17.22 QC should evaluate the quality and stability of finished pharmaceutical products and, when necessary, of starting materials and intermediate products. 17.23 QC should establish expiry dates and shelf-life specifications on the basis of stability tests related to storage conditions. 17.24 A written programme for ongoing stability determination should be developed and implemented to include elements such as: (a) a complete description of the medicine involved in the study; (b) the complete set of testing parameters and methods, describing all tests for potency, purity, and physical characteristics and documented evidence that these tests indicate stability; (c) provision for the inclusion of a sufficient number of batches; (d) the testing schedule for each medicine; (e) provision for special storage conditions; (f) provision for adequate sample retention; (g) a summary of all the data generated, including the evaluation and the conclusions of the study. 17.25 Stability should be determined prior to marketing and following any significant changes, for example, in processes, equipment or packaging materials. https://www.google.ru/url?sa=t&rct=j&q=&esrc=s&source=web&cd... -------------------------------------------------- Note added at 2 час (2021-01-25 21:30:34 GMT) -------------------------------------------------- См. также: World Health Organization STABILITY TESTING OF ACTIVE PHARMACEUTICAL INGREDIENTS AND FINISHED PHARMACEUTICAL PRODUCTS (January 2017) DRAFT FOR COMMENT (Working document QAS/17.694 January 2017 Draft document for comment) Introduction and background The Stability testing of active pharmaceutical ingredients and finished pharmaceutical products was published as Annex 2 in the WHO Technical Report Series, No. 953, 2009 (1). These regulatory guidelines seek to exemplify the core stability data package required for registration of active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs), replacing the previous WHO guidelines in this area. The guidelines cross-reference to the series of related International Council on Harmonisation (ICH) guidelines (2) and other WHO guidelines. It was recommended at the time of publication that these guidelines should also be applied to products that are already being marketed, with allowance for an appropriate transition period, e.g. upon re-registration or upon re-evaluation. https://www.google.ru/url?sa=t&rct=j&q=&esrc=s&source=web&cd... |
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