GOST R 52896-2017

ГОСТ Р 52896-2017

Manufacturing of medicinal product. Manufacturing systems and equipment for the production of medicines. General requirements

Производство лекарственных средств. Производственные системы и оборудование для производства лекарственных средств. Общие требования

Status: Effective - Supersedes. IUS 1-2018

This standard applies to all elements of the pharmaceutical and biopharmaceutical production systems, including: engineering equipment, production equipment, auxiliary systems, associated monitoring and control systems, and automation systems that can affect patient quality and safety (further-production systems). Also, this standard can be applied to laboratory and information production systems, as well as to the production systems of medical equipment. This standard applies to both new and existing production systems. The approach described in the standard can be used to introduce changes to existing systems and their continuous improvement during operation. This standard applies to production systems throughout their life cycle, from concept development to decommissioning.

Настоящий стандарт применим ко всем элементам фармацевтических и биофармацевтических производственных систем, в том числе: инженерно-техническому оборудованию, производственному оборудованию, вспомогательным системам, связанным с ними системам мониторинга и контроля, а также системам автоматизации, которые способны оказывать влияние на качество продукции и безопасность пациента (далее-производственные системы). Также данный стандарт может быть применим к лабораторным и информационным производственным системам, а также к производственным системам медицинского оборудования. Настоящий стандарт применим как к новым, так и к уже существующим производственным системам. Описанный в стандарте подход может использоваться для внедрения изменений в существующие системы и их непрерывное улучшение в процессе эксплуатации. Настоящий стандарт применим к производственным системам на протяжении всего их жизненного цикла, от разработки концепции до прекращения эксплуатации

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Format: Electronic (pdf/doc)
Page Count: 12

Approved: Federal Agency for Technical Regulation and Metrology, 9/8/2017

SKU: RUSS287570

Price: $118.80

The Product is Contained in the Following Classifiers:

ISO classifier » 11 HEALTH » 11.120 Pharmaceuticals » 11.120.01 Pharmaceuticals in general »

National standards » 11 HEALTH » 11.120 Pharmaceuticals » 11.120.01 Pharmaceuticals in general »

ISO classifier » 13 ENVIRONMENTAL PROTECTION, HUMAN PROTECTION AGAINST ENVIRONMENTAL IMPACT. SECURITY » 13.060 Water quality » 13.060.70 Study of biological properties of water »

National standards » 13 ENVIRONMENTAL PROTECTION, HUMAN PROTECTION AGAINST ENVIRONMENTAL IMPACT. SECURITY » 13.060 Water quality » 13.060.70 Study of biological properties of water »

As a Replacement Of:

GOST R 52896-2007: Manufacturing of medicinal products. Processing equipment for manufacturing of solid dosage forms. General requirements

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