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美国自愿性标准涉及良好生产规范和通风控制标准

发布时间: 2017-07-05 08:56:50   审校:睿智   浏览次数:
来源:https://www.ansi.org/news_publications/news_story?menuid=7&articleid=26da6703-cd23-472a-b901-c6bd2f1  

为了宣传标准在日常生活中的重要作用,美国国家标准协会(ANSI)发布了在全球和国家标准领域采用的各种标准制定的动态消息,其中许多标准是由ANSI成员和ANSI认可的标准制定组织制定。 其中两项最新标准如下:

一、药用辅料的良好生产规范

药用辅料用于药物制剂中,影响药品的外观、稳定性和传递过程。这类辅料的生产过程对药品的安全和质量至关重要,必须符合生产商规定的指标,此外,还必须符合客户和监管机构的要求和期望。

NSF / IPEC / ANSI 363-2016,药用辅料良好生产规范,为药用辅料生产中所采用的质量管理体系提供了全面的依据。于近期内修订的该项标准,旨在界定药用辅料的生产质量和分销管理规范,规定了适用于所有市售药用辅料质量管理规范的最低要求。此外,药用辅料生产质量管理规范确保了药用辅料的适用性。

该项标准由美国国家卫生基金会(NSF International)发布,该项标准还提供指导,确定药用辅料符合生产商规定的定性或定量指标,且不含未申报的特定污染物。该项标准由药用辅料生产商、分销商和公共卫生监管机构共同制定。

NSF International是ANSI成员和认可的标准制定组织,该组织负责撰写公共卫生标准、协议和测试,并对水、食品和消费品行业的产品进行认证。

二、商用烹饪操作的通风控制和防火标准

操作性消防安全要求可降低公共和私人商用烹饪操作的火灾隐患,包括餐厅、食堂和疗养院等场所。

美国国家消防协会(NFPA)发布NFPA 96-2017,商用烹饪操作通风控制和防火修订标准。该项标准规定了所有有关公共和私人烹饪设计、安装、操作、检查和维护的最低消防安全要求(预防和操作)。此要求包括但不限于各种烹饪设备、排气罩、油脂清除装置、排气管道系统、排风扇、阻尼器、灭火设备,以及用于收集控制烹饪中含油污水的所有辅助部件或系统。

NFPA是ANSI成员和经审核的机构,致力于制定和推广共识编码与标准、研究、教育培训,竭力防止火灾发生,降低火灾影响,包括制定保障消防员安全和健康的相关程序。

 

Voluntary Standards Cover the Spectrum: from Good Manufacturing Practices to Ventilation Control

In an effort to communicate the vital role that standards play in daily life, the American National Standards Institute (ANSI) publishes snapshots of the diverse standards initiatives undertaken in the global and national standards arena, many of which are performed by ANSI members and ANSI-accredited standards developers. Two of the latest selections follow:

Good Manufacturing Practices for Pharmaceutical Excipients

Pharmaceutical excipients are used in pharmaceutical preparations to impact the appearance, stability, and delivery of drug products. The manufacturing process of such excipients is essential to the safety and quality of these products and must meet specifications stated by the manufacturer. Furthermore, it must meet the requirements and expectations of customers and regulatory authorities.

NSF/IPEC/ANSI 363-2016, Good Manufacturing Practices for Pharmaceutical Excipients, provides a comprehensive basis for the quality management system used in the manufacture of pharmaceutical excipients. The recently revised standard is intended to define good manufacturing practices (GMP) for excipient manufacture and distribution for use in drug products. It sets minimum requirements for GMP applicable to all commercially available excipients. In addition, adherence to excipient GMP provides assurance that excipients are suitable for use in drug products.

Published by NSF International, the standard also provides guidance to allow for the determination that a pharmaceutical excipient is within the specifications stated by the manufacturer, either qualitatively or quantitatively, and that it does not contain specific undeclared contaminants. The standard was developed with participation from the pharmaceutical excipients manufacturers, public health regulators, and distributors of pharmaceutical excipients.

An ANSI member and accredited standards developer, NSF International writes public health standards and protocols and tests, and certifies products for the water, food, and consumer goods industries.

Ventilation Control and Fire Protection of Commercial Cooking Operations

Operative fire safety requirements can reduce the potential fire hazard of both public and private commercial cooking operations—which can range from restaurants to cafeterias to nursing homes.

The National Fire Protection Association’s (NFPA’s) revised NFPA 96-2017, Standard for Ventilation Control and Fire Protection of Commercial Cooking Operations, provides the minimum fire safety requirements (preventative and operative) related to the design, installation, operation, inspection, and maintenance of all public and private cooking operations. Requirements include, but are not limited to, all manner of cooking equipment, exhaust hoods, grease removal devices, exhaust ductwork, exhaust fans, dampers, fire-extinguishing equipment, and all other auxiliary or ancillary components or systems that are involved in the capture, containment, and control of grease-laden cooking effluent.

NFPA, an ANSI member and audited designator, is committed to producing and promoting consensus codes and standards, research, and training and education, and works to prevent fires as well as to lessen the impact of fires when they do occur, which includes developing procedures that will keep firefighters safe and healthy.

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