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。
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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