I:

Any component present in the intermediate or API that is not the desired entity.

Measurement where the sample is not removed from the process stream and can be invasive or noninvasive.

US Food and Drug Administration, U.S., Rockville, MD Guidance for Industry, PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, September 2004, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070305.pdf

Checks performed during production in order to monitor and if necessary to adjust the process and/or to ensure that the intermediate or API conforms to its specification.

Any material(s) fabricated, compounded, blended, or synthesized using a chemical , physical, or biological process that is produced for and being used in the preparation of an intermediate, drug substance, or drug product.

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

Measurements performed during manufacturing and pertaining to the process or products within the process.

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

See common cause variability

The introduction of new technologies or methodologies.

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

A material produced during steps of the processing of an API that undergoes further molecular change or purification before it becomes an API.

Intermediate precision expresses within-laboratories variations: different days, different analysts, different equipment, etc.

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

ICH is an undertaking that brings together the drug regulatory authorities and the pharmaceutical industry of Europe, Japan, and the United States.

ICH, viewed: March 2012, http://www.ich.org/about/vision.html

ISPE is an individual membership society for professionals involved in the manufacture of pharmaceuticals and related products.

International Society for Pharmaceutical Engineering, U.S., Tampa, FL, viewed: March 2012, http://www.ispe.org/about-ispe

See repeatability

ISA-88 is an international standard. It helps industries to produce in a flexible way. The standard consists of models and terminology for structuring the production process and for developing the control of equipment. ISA-88 can be applied in fully automated, semi automated and even in completely manual production processes.

ISA, U.S., Durham, NC , viewed: March 2012, http://www.isa-88.com/

See cause and effect diagramm

K:

Metrics used to quantify quality objectives to reflect the performance of an organization, process, or 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

An adjustable parameter of the process that, when maintained within a narrow range, ensures optimum process performance. A KPP does not affect CQAs of the product.

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

Metrics used to quantify product quality objectives to reflect the performance of a quality control strategy.

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

Multidimensional region encompassing internally and externally derived knowledge. Relating to properties of API, formulation design etc. explored and/or modelled, relevant to the product under development.

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

The sum of existing information composed of prior knowledge, the body of scientific information and data about the product and process.

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

L:

All phases in the life of a product from the initial development through marketing until the product"s discontinuation.

See detection limit

The linearity of an analytical procedure and its ability (within a given range) to obtain test results which are directly proportional to the concentration (amount) of analyte in the sample.

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

M:

All operations of receipt of materials, production, packaging, repackaging, labeling, relabeling, wuality control, release, storage, and distribution of APIs and related controls.

A set of activities or operations performed to deliver a desired output.

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

A general term used to denote raw materials, process aids, intermediate, APIs, and packaging and labeling materials.

The residual liquid that remains after the crystallization or isolation processes. A mother liquor may contain unreacted materials, intermediates, levels of the API, and/or impurities. It can be used for further processing.

A method for relating the variations in a response variable (Y-variable) to the variations of several predictors (Xvariables), with explanatory or predictive purposes. An important assumption for the method is that the X-variables are linearly independent, i.e. that no linear relationship exists between the X-variables. When the X-variables carry common information, problems can arise due to exact or approximate collinearity.

CAMO Software, Norway, Oslo Glossary for Multivariate Statistical Methods, viewed: March 2012, http://www.camo.com/downloads/Glossary_of_terms.pdf

Multivariate analysis (MVDA) is based on the statistical principle of multivariate statistics, which involves observation and analysis of more than one statistical variable at a time. In design and analysis, the technique is used to perform trade studies across multiple dimensions while taking into account the effects of all variables on the responses of interest.

CAMO Software, Norway, Oslo Glossary for Multivariate Statistical Methods, viewed: March 2012, http://www.camo.com/downloads/Glossary_of_terms.pdf

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