farmaceuticas no segregadas y segradas
English translation: drugs manufactured in non-dedicated / dedicated facilities // non-hazardous / hazardous drugs
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| 16:48 Mar 10, 2017 |
| Spanish to English translations [PRO] Science - Medical: Pharmaceuticals | |||||||
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|  Selected response from: Charles Davis Spain Local time: 02:50 | ||||||
Grading comment
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| Summary of answers provided | ||||
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| 3 | non-hazardous / hazardous |
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| Summary of reference entries provided | |||
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| Segregation |
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| Discussion entries: 5 | |
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Answers
5 hrs confidence: 
non-hazardous / hazardous Explanation: I am 100% sure that Helena has correctly interpreted "segregado". But that still leaves the problem of how to translate it, unless you actually use "produced in segregated / non-segregated facilities", which is one option. (Actually I think that if you go that way the word is "dedicated" rather than "segregated".) What seems clear is that they aren't called "segregated drugs", which will almost certainly be misunderstood if you use it here (see Robert's reference), and none of the possible synonyms I've tried searching for produce helpful results either. I don't think this way of classifying drugs is used in English. I'd like to propose a different approach, using terms that certainly are used and that I think are equivalent. Here is a useful Argentine document which defines "segregados". En caso de elaborarse productos con principios activos segregados (betalactámicos, citostáticos, citotóxicos, hormonales, antihormonales, biológicos/biotecnológicos con microorganismos vivos o derivados de la sangre y plasma) indicar si se elaboran en plantas independientes (separadas físicamente) o en la misma planta de elaboración de productos con activos no segregados, en áreas independientes y autónomas o bajo el principio de campaña." http://studylib.es/doc/390560/página--1-informativo-nº-211-2... (section 1.2.3, p. 4). And here is a discussion document from the European Medicines Agency: "Overview of comments received on 'Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’", in which "hazardous drugs" is pretty well the same list: "The PDE [permitted daily exposure] approach should in any case not be required for all medicinal products and all active substances but should be an option for companies that chose to follow it e.g. by the producers of certain hazardous contaminants such as highly sensitising materials (such as beta lactams), biological preparations (e.g. from live micro-organisms), certain hormones, cytotoxics, and other highly active materials." [...] "The really highly hazardous medicinal compounds are today manufactured in dedicated equipment/plant according to the principles in PIC/ S PI006-03." http://www.ema.europa.eu/docs/en_GB/document_library/Overvie... -------------------------------------------------- Note added at 4 days (2017-03-15 09:14:18 GMT) Post-grading -------------------------------------------------- That's very nice of you, Jane. I do think the translation you decided to use is more prudent, and I'm going to put it in the glossary. Helena did great work here, even though she didn't actually post an answer. |
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23 mins |
| Reference: Segregation Reference information: All the good work put into achieving a proper mix or blend of pharmaceutical compounds can be undone whenever the batch is moved and segregation opportunities arise. Segregation is the process of involuntary separation of fractions of a bulk solid that were previously homo-geneously dispersed throughout the mass of material. As such, it is the direct opposite of blending and mixing. Segregation is pervasive and pernicious. Opportunities to segregate occur in every stage of handling and processing of pharmaceutical powders, and are especially common during transfer to an intermediate vessel. As the powder is transferred into a hopper, its flow and discharge pattern can cause ‘repose segregation’ where small powder particles are concentrated in the middle channel of the hopper and larger particles closer to the vessel wall. If the flow out of the intermediate hopper is non-mass flow, then the first powder out is too fine and the last out too coarse, leading to quality issues at the beginning and end of the batch. https://en.wikipedia.org/wiki/Particle_segregation -------------------------------------------------- Note added at 29 mins (2017-03-10 17:18:17 GMT) -------------------------------------------------- Sorry, that link is wrong, this is the correct one: https://www.manufacturingchemist.com/news/article_page/How_t... |
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24 mins peer agreement (net): +3 |
| Reference Reference information: Dosificación y test disolución de materias primas y formas farmacéuticas segregadas (Hormonas y citostaticos). http://www.kemia.com.uy/ -------------------------------------------------- Note added at 37 mins (2017-03-10 17:26:11 GMT) -------------------------------------------------- Using shared facilities A significant issue has been whether manufacturers can use shared facilities for manufacturing highly potent drugs. FDA regulations say that penicillins must be processed in dedicated, segregated facilities, and a 2013 FDA guidance added that beta lactams should also be segregated (2). Other products may be manufactured in shared facilities if precautions are taken to prevent cross contamination or mixups, noted Stephanie Wilkins, president of PharmaConsult US, in a presentation at Interphex 2014 (3). http://www.pharmtech.com/evaluating-cross-contamination-risk... It would appear to mean drugs prepared/manufactured in segregated facilities -------------------------------------------------- Note added at 42 mins (2017-03-10 17:30:51 GMT) -------------------------------------------------- In addition, new approaches, technologies, and innovations in the design, construction, and operations of an MPF, including retrofitting, building new single-use systems or disposables, and hard-copy or electronic record-keeping are available for implementation. However, operations must meet regulatory compliance requirements for good manufacturing practices (GMPs) to ensure product quality and consistency. Regulations on segregation of toxic or infectious materials (e.g., antibiotics, spore formers, live vaccines, highly toxic compounds) must be observed. http://www.bioprocessintl.com/manufacturing/monoclonal-antib... -------------------------------------------------- Note added at 57 mins (2017-03-10 17:46:32 GMT) -------------------------------------------------- Regulatory authorities across the world have created rules and guidelines as part of good manufacturing practice (GMP) to prevent cross-contamination and in order to protect patients and workers. As these directives continuously evolve, manufacturing technologies change and improve as drugs become more specialized or potent. While recommendations differ from country to country, the broad trend has been to segregate the manufacturing of specific types of products. “The FDA has been moving towards keeping the manufacturing of penicillin and non-penicillin-based drugs separate over the last 40 years,” says Jim Agalloco, a consultant with Agalloco & Associates in Belle Mead, N.J. http://www.ilcdover.com/sites/default/files/one_2_one_cross_... I'm convinced it means that the drugs have been manufactured in non-segregated/segregated conditions. -------------------------------------------------- Note added at 1 hr (2017-03-10 18:01:54 GMT) -------------------------------------------------- Once the drugs have been wrapped in silver foil and are in their boxes, do they need to be segregated? -------------------------------------------------- Note added at 1 hr (2017-03-10 18:15:18 GMT) -------------------------------------------------- From a Word doc. El observante solicita que las Bases incluyan la exigencia de que el certificado de Buenas Prácticas de Manufactura demuestre que los productos oncológicos son fabricados en áreas independientes especiales y/o en condiciones diferentes. Sustenta su solicitud señalando que la Red Panamericana para la Armonización de Regulación Farmacéutica establece que la fabricación de productos especiales (oncológicos) debe realizarse en áreas especiales y/o en condiciones diferentes, según lo indica el Informe 32 y las actualizaciones de la Organización Mundial de la Salud. Agrega que la Guía de Verificación de Buenas Prácticas de Manufactura de la Organización Panamericana de la Salud establece los parámetros de evaluación de las plantas que fabrican productos farmacéuticos segregados (altamente sensibilizantes y activos) entre los que se encuentran los productos citostáticos (oncológicos). |
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