R:

The range of an analytical procedure is the interval between the upper and lower concentration (amounts) of analyte in the sample (including these concentrations) for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity.

ICH, Switzerland, Geneva ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2(R1), November 2005, http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf

A general term used to denote starting materials, reagents, and solvents intended for use in the production of intermediates or APIs.

The ability to evaluate and ensure the quality of in-process and/or final product based on process data, which typically include a valid combination of measured material attributes and process controls.

US Food and Drug Administration, U.S., Rockville, MD Guidance for Industry, Q8(R2) Pharmaceutical Development, November 2009, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073507.pdf

The ability to evaluate and ensure the acceptable quality of in-process and/or final product based on process data, which typically include a valid combination of assessed material attributes and process controls.

US Food and Drug Administration, U.S., Rockville, MD Guidance for Industry, Q8(R2) Pharmaceutical Development, November 2009, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073507.pdf

The necessary set of information that uniquely defines the production requirements for a specific product or operational procedure.

A substance that has been shown by an extensive set of analytical tests to be authentic material that should be of high purity. This standard can be: (1) obtained from an officially recognized source, (2) prepared by independent synthesis, (3) obtained from existing production material of high purity, or (4) prepared by further purification of existing production material.

A substance of established quality and purity, as shown by comparison to a primary reference standard, used as a reference standard for routine laboratory analysis.

Repeatability expresses the precision under the same operating conditions over a short interval of time. Repeatability is also termed intra-assay precision.

ICH, Switzerland, Geneva ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2(R1), November 2005, http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf

Introducing an intermediate or API, including one that does not conform to standards or specifications, back into the process and repeating a crystallization step or other appropriate chemical or physical manipulation steps (e.g., distillation, filtration, chromatography, milling) that are part of the established manufacturing process. Continuation of a process step after an in-process control test has shown that the step is incomplete, is considered to be part of the normal process, and is not reprocessing.

Reproducibility expresses the precision between laboratories (collaborative studies, usually applied to standardization of methodology).

ICH, Switzerland, Geneva ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2(R1), November 2005, http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf

The explicit or implicit needs or expectations of the patients or their surrogates (e.g., health care professionals, regulators, and legislators). In this document, requirements refers not only to statutory, legislative, or regulatory requirements, but also to such needs and expectations.

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 date when a material should be re-examined to ensure that it is still suitable for use.

Subjecting an intermediate or API that does not conform to standards or specifications to one or more processing steps that are different from the established manufacturing process to obtain acceptable quality intermediate or API (e.g., recrystallizing with a different solvent).

The combination of the probability of occurrence of harm and the severity of that 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 decision to accept risk.

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 estimation of the risk associated with the identified hazards.

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

A systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards.

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 sharing of information about risk and risk management between the decision maker and other stakeholders.

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

Actions implementing risk management decisions.

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 comparison of the estimated risk to given risk criteria using a quantitative or qualitative scale to determine the significance of the risk.

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 systematic use of information to identify potential sources of harm (hazards) referring to the risk question or problem description.

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 systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating, and reviewing risk.

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 risk ranking and filtering method intent is to provide sharper focus to the critical risks within a system – typically, from a large and complex set of risk scenarios. Risk Ranking and Filtering works by breaking down overall risk into risk components and evaluating those components and their individual contributions to overall risk.

Actions taken to lessen the probability of occurence of harm and the severity of that 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

Review or monitoring of output/results of the risk management process considering new knowledge and experience about the risk.

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 robustness of an analytical procedure is a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage.

ICH, Switzerland, Geneva ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2(R1), November 2005, http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf

See characterization study

S:

A portion, piece, or segment that is representative of a whole.

ASTM International, U.S., West Conshohocken, PA E2363-06a Standard Terminology Relating to Process Analytical Technology in the pharmaceutical Industry., 1. July 2006, http://www.astm.org/Standards/E2363.htm

Person(s) who direct and control a company or site at the highest levels with the authority and responsibility to mobilize resources within the company or site.

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 target value for a process parameter. The range around the set point is commonly stated in the manufacturing procedures or batch records.

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 measure of the possible consequences of a hazard.

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 record of the individual who performed a particular action or review. This record can be initials, full handwritten signature, personal seal, or authenticated and secure electronic signature.

A method that provides organizations tools to improve the capability of their business processes. This increase in performance and decrease in process variation lead to defect reduction and improvement in profits, employee morale and quality of products or services. Six Sigma quality is a term generally used to indicate a process is well controlled (±6 s from the centerline in a control chart).

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

Nonrandom variability, which is transient and often assignable in nature. By definition, this type of variability is not inherent, predictable (probabilistically), or definable. Causes of variation that arise because of special circumstances. They are not an inherent part of a process. Special causes are also referred to as assignable causes.

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

A specification is a list of tests, references to analytical procedures, and appropiate acceptance criteria with numerical limits, ranges, or other criteria for the tests described, which establishes the set of criteria to which a drug should conform to be considered acceptable for its intended use.

The combination of tests that determine the suitability of a drug product at the time of its release.

Any individual group, or organization that can affect, be affected by, or perceive itself to be affected by a risk. Decision makers might also be stakeholders.

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

A condition in which the set of controls consistently provides assurance of continued process performance and product quality.

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 application of statistical techniques to control a process; often used interchangeably with the term “statistical quality control”.

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

Variation caused by regular, systematic changes in output, such as seasonal patterns and long-term trends.

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

Supervisory Control and Data Acquisition (SCADA) is the process by which automation applications collect data and use it for supervisory control.

OPC Training Institute, Canada, Edmonton, Alberta, viewed: March 2012, http://www.opcti.com/Dictionary.aspx?type=1&term=112&AspxAutoDetectCookieSupport=1

Addresses the analysis of entire biological systems. It is an interdisciplinary approach to the investigation of all the components and networks contributing to a biological system.

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

T:

Action taken to compensate for variation within the control limits of a stable system; tampering increases rather than decreases variation, as evidenced in the funnel experiment.

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

A target product profile is a format for a summary of a drug development program described in terms of labeling concepts. A TPP can be prepared by a sponsor and then shared with the appropriate FDA review staff to facilitate communication regarding a particular drug development program.

US Food and Drug Administration, U.S., Rockville, MD Guidance for Industry and Review Staff, Target Product Profile - A Strategic Development Process Tool, March 2007, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080593.pdf

The target product quality profile is a quantitative surrogate for aspects of clinical safety and efficiacy that can be used to design and optimize a formulation and manufacturing process.

R. A. Lionberger et al. Iin AAPS Journal, Vol. 10 Quality by Design: Concepts for ANDAs, June 2008, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2751376/pdf/12248_2008_Article_9026.pdf

A determination as to wheter routine monitoring, characterization testing, in-process monitoring, stability testing, or no testing is conducted as a part of the overall control strategy.

CMC-Biotech Working Group A-Mab: a Case Study in Bioprocess Development, Version 2.1, 30. October 2009, http://www.ispe.org/pqli/a-mab-case-study-version-2.1

A statistical term referring to the direction or rate of change of variables/ a variable.

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

See accuracy

U:

An analytical method that measures the absorption of light in the 20-750 nm range of the electromagnetic spectrum. It is used in determining protein concentration and is often applied to HPLC detection.

International Society for Pharmaceutical Engineering, U.S., Tampa, FL, viewed: March 2012, http://www.ispe.org/glossary?term=UV-vis+%28Ultraviolet+visible+spectroscopy%29

A process parameter whose criticality is undetermined or unknown at the beginning of a development process. Unclassified process parameters may be later classified as critical or noncritical.

R. A. Lionberger et al. Iin AAPS Journal, Vol. 10 Quality by Design: Concepts for ANDAs, June 2008, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2751376/pdf/12248_2008_Article_9026.pdf

A process parameter whose criticality is undetermined or unknown at the beginning of a development process. Unclassified process parameters may be later classified as critical or noncritical.

R. A. Lionberger et al. Iin AAPS Journal, Vol. 10 Quality by Design: Concepts for ANDAs, June 2008, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2751376/pdf/12248_2008_Article_9026.pdf

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