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GB28670-2012
General rule of pharmaceutical machinery conforming to good manufacturing practice
制药机械（设备）实施药品生产质量管理规范的通则
GB 28670-2012 — действующий обязательный национальный стандарт Китая: General rule of pharmaceutical machinery conforming to good manufacturing practice. Отрасль: Электроника. Тема: Охрана труда. Дата вступления в силу: 1 июл. 2013 г..
Применимость зависит от продукции, схемы сертификации, уведомлений компетентных органов и переходных правил. Закажите перевод или проверьте источник, прежде чем использовать эту запись в решениях по соответствию.
Обзор требований
Этот обзор пока доступен только на английском языке.
Область применения
This standard specifies the general requirements for pharmaceutical machinery and equipment conforming to Good Manufacturing Practice (GMP). It applies to the product design, manufacturing, inspection, installation, operation, maintenance, and validation of equipment used in pharmaceutical production. It is mandatory for all manufacturers producing pharmaceutical equipment for the Chinese market, covering categories like raw material machinery, preparation equipment, and sterile production devices.
Технические требования
The standard establishes overarching principles requiring equipment to minimize risks of contamination, cross-contamination, and errors during drug production. It mandates the establishment of a quality management system and requires that equipment must be easy to operate, maintain, clean, and sterilize. Manufacturers must ensure that equipment design strictly aligns with the 2010 GMP revision. Regarding materials and structural design, the standard specifies that surfaces in direct contact with drugs must be non-toxic, corrosion-resistant, and free of cleaning blind spots. It outlines requirements for lubricants, necessitating the use of food-grade equivalents where applicable, and mandates dust collection devices for equipment generating particulate matter. GB 150 and GB 5226.1 are frequently referenced for pressure vessel and electrical safety compliance. The document provides specific technical categorizations for various equipment types, including raw material machinery, preparation equipment, and pharmaceutical water systems. For instance, water generation systems must prevent microbial growth and feature online monitoring capabilities. Equipment used in sterile drug production must incorporate advanced isolation technologies like RABS or isolators to maintain required cleanroom classifications. Safety and validation are critical components, requiring overload protection, fault alarms, and explosion-proof measures for hazardous environments. The standard also dictates that installation and validation processes must adhere to corresponding national guidelines, ensuring full lifecycle compliance.
Методы испытаний
The standard outlines evaluation procedures focusing on operational stability, cleanability, and sterilization efficacy. Key assessments include verifying the integrity of filters used in sterile environments, testing the effectiveness of dust collection and explosion-proof systems, and validating the online monitoring of critical parameters like temperature, pressure, and conductivity in pharmaceutical water systems. Comprehensive validation must be performed according to the guidelines in GB/T 28671-2012 before equipment deployment.
Частые вопросы
What products are regulated under GB 28670-2012?
It regulates all pharmaceutical machinery and equipment, including raw material processing machines, preparation equipment, packaging machines, and sterile production devices like isolators and RABS.
Is GB 28670-2012 a mandatory standard?
Yes, the majority of the standard is mandatory, with only sections 4.1 to 4.4 being recommended. Compliance is essential for entering the Chinese pharmaceutical equipment market.
Does this standard reference international GMP guidelines?
The standard is specifically aligned with the Chinese Good Manufacturing Practice (2010 Revision) and references various national standards (GB series) for technical specifics, rather than directly adopting ISO guidelines.
The summary above provides a high-level overview of GB 28670-2012. To ensure complete compliance for your pharmaceutical equipment entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 28670-2012 today to access all detailed parameters, material requirements, and validation procedures.
Подсказки по применимости
- Тип
- Управление
- CCS
- C90
- ICS
- 11.120
- Компетентное ведомство
- Ministry of Industry and Information Technology
- Технический комитет
- Ministry of Industry and Information Technology