E:

The boundary to a variable or parameter, beyond which the relevant quality attributes or specifications cannot be met.

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

A tool or process that provides the means to achieve an objective.

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 characterization study

EMA is a decentralised agency of the EU, located in London, with responsibility for scientific evaluation of medicines developed by pharmaceutical companies for use in the EU.

EMA, http://www.ema.europa.eu/ema/

An ingredient added intentionally to the drug substance which should not have pharmacological properties in the quantity used.

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:

A drug that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.

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

H:

The hazard analysis and critical control point methodology is a systematic, proactive and preventive risk management tool for assuring product quality, reliability and safety. It is a structured approach that implies technical and scientific principles to analyze, evaluate, prevent, and control the risk or adverse consequence(s) of hazard(s) due to the design, development, production, and use of products.

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

Damage to health, including the damage that can occur from loss of product quality or availability.

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

The potential source of harm.

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

The hazard operability analysis is a risk management methodology based on a theory that assumes that risk events are caused by deviations from the design or operating intentions. It is a systematic brainstroming technique for identifying hazards using so-called guide words (e.g., No, More, Other) which are applied to relevant parameters to help identify potential deviations from normal use or design intentions.

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