E:

变量或参数的边界,即超出该边界就不能满足相关的质量属性或规范。

C. Julien and W. Whitford in BioProcess International "Hitchhikers"s Guide" to Bioprocess Design, March 2008, http://www.bioprocessintl.com/multimedia/archive/00078/BPI_A_080603SUPAR07__78643a.pdf

提供目标实现方法的工具或工艺。

US Food and Drug Administration, U.S., Rockville, MD Guidance for Industry , Q10 Pharmaceutical Quality System, April 2009, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073517.pdf

见表征研究

EMA(欧洲药品管理局)是欧盟的一个分支机构,位于伦敦,负责对欧盟制药公司开发的药物进行科学评估。

EMA, http://www.ema.europa.eu/ema/

在剂型、规格、给药途径、质量、性能特征和预期用途上可与原创药物相媲美的药物。

US Food and Drug Administration, U.S., Rockville, MD Guideline for Industry, Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, August 1999, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073488.pdf

F:

A procedure to determine which malfunction symptoms appear immediately before or after a failure of a critical parameter in a system. After all possible causes are listed for each symptom, the product is designed to eliminate the problems.

American Society for Quality - ASQ, U.S., Milwaukee, WI, viewed: March 2012, http://asq.org/glossary/

A systematized group of activities to recognize and evaluate the potential failure of a product or process and its effects, identify actions that could eliminate or reduce the occurrence of the potential failure and document the process.

American Society for Quality - ASQ, U.S., Milwaukee, WI, viewed: March 2012, http://asq.org/glossary/

A procedure performed after a failure mode effects analysis to classify each potential failure effect according to its severity and probability of occurrence.

American Society for Quality - ASQ, U.S., Milwaukee, WI, viewed: March 2012, http://asq.org/glossary/

Fault tree analysis is a risk management tool concerning with the identification and analysis of conditions and factors that cause or may potentially cause or contribute to the occurence of a defined top event. FTA evaluates system failures one at a time but can combine multiple causes of failure by identifying causal chains.

The modification or control of a process or system by its results or effects. It can be can be applied technically in process control strategies and conceptually in quality management.

US Food and Drug Administration, U.S., Rockville, MD Guidance for Industry , Q10 Pharmaceutical Quality System, April 2009, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073517.pdf

The modification or control of a process using its anticipated results or effects. It can be can be applied technically in process control strategies and conceptually in quality management.

US Food and Drug Administration, U.S., Rockville, MD Guidance for Industry , Q10 Pharmaceutical Quality System, April 2009, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073517.pdf

See drug product

See cause and effect diagramm

The FDA is a federal science-based law enforcement agency mandated to protect public health and safety.

https://www.fda.gov/

G:

在剂型、规格、给药途径、质量、性能特征和预期用途上可与原创药物相媲美的药物。

US Food and Drug Administration, U.S., Rockville, MD, viewed: March 2012, http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/abbreviatednewdrugapplicationandagenerics/default.htm

H:

危害分析和关键控制点方法是一种系统性、主动和预防性的风险管理工具,用以确保产品的质量、可靠性和安全性。它是一种结构化的方法,包含了分析、评估、预防和控制由于产品设计、开发、生产和使用而导致的风险或有害后果的科技原理。

US Food and Drug Administration, U.S., Rockville, MD; World Health Organization WHO, Switzerland, Geneva Guidance for Industry, Q9 Quality Risk Management; Application of hazard analysis and critical control point (HACCP) methodology to pharmaceuticals (in WHO Expert Committee on Specifications for Pharmaceutical Preparations, Technical Report Series, No. 908, 2003, Annex 7), June 2006, http://apps.who.int/medicinedocs/en/d/Js5517e/23.html#Js5517e.23

对健康的损害,包括由于产品质量或可用性损失所导致的损害。

US Food and Drug Administration, U.S., Rockville, MD Guidance for Industry, Q9 Quality Risk Management, June 2006, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073511.pdf

潜在的伤害来源。

US Food and Drug Administration, U.S., Rockville, MD Guidance for Industry, Q9 Quality Risk Management, June 2006, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073511.pdf

危险可操作性分析是一种基于理论的风险管理方法,该理论假定风险事件是由偏离设计或操作意图引起的。它是一种系统性的头脑风暴法,通过所谓的引导词(如:无、更多、其它)来识别危险,这些词应用于相关参数,以帮助识别与正常使用或设计意图之间存在的潜在偏差。

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