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PDA Technical Glossary

PDA Technical Reports are highly valued membership benefits because they offer expert guidance and opinions on important scientific and regulatory topics and are used as essential references by industry and regulatory authorities around the world. These reports include terms which explain the material and enhance the reader’s understanding.

The database presented here includes the glossary terms from all current technical reports. The database is searchable by keyword, topic, or by technical report. Each definition provided includes a link to the source technical report within the PDA Technical Report Portal.

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TR 49: Validation: Cleaning Biotech

Recovery Study

A laboratory study combining the sampling method and analytical method to determine the quantitative recovery of a specific residue for a defined surface. (TR29) A laboratory study combining the sampling method and analytical method to determine the quantitative recovery of a specific residue for a defined surface. (TR49)

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Normal Dose

The therapeutic dose of a product as given on the approved product labeling. (TR29) (TR49)

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Limit

A value for a residue above which a cleaning process would not be acceptable. (TR29) A value for a residue above which a cleaning validation protocol would fail. (TR49)

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Grouping Strategy

A strategy for establishing similar cleaning processes, usually based on similar products or similar equipment, and to validate the cleaning process based primarily on validation data for a representative of the group. (TR29) (TR49)

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Degradation

The breakdown (usually chemical) of material during manufacture, including during and after the cleaning process. (TR49) (TR70)

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Coupon

A small, generally flat portion of a defined material of construction (such as stainless steel or PTFE) and of a defined surface finish, typically used for laboratory cleaning evaluations and/or for laboratory sampling recovery studies. (TR29) (TR49)

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Cleaning Validation

Documented evidence with a high degree of assurance that a cleaning process will result in products meeting their predetermined quality attributes throughout its life cycle. (TR29)(TR49)

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Cleaning Verification

A one-time sampling and testing to ensure that specified equipment has been properly cleaned following a specific cleaning event. (TR29) (TR49)

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Clean

Having product residues, process residues, and environmental contaminants removed to an acceptable level. (TR29) (TR49) The implementation of procedures to render an area, piece of equipment, system, or object free of adulterants and contaminants. (TR 70)

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Blank

Analytical sample taken to establish background value for the analytical measurement which may be subtracted from an experimental value to determine the “true” value. (TR29) (TR49)

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Analyte

Substance (usually a residue) for which an analysis is being performed. (TR29) (TR49) (TR70) A specific chemical moiety being measured, which can be intact drug, biomolecule or its derivative, impurity, and/or excipients in a drug product. [Synonym: measurand] (TR57)

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Acceptable Daily Intake

An amount of a substance consumed on a daily basis that is considered at a safe level. (TR29) An amount of a substance administered or consumed on a daily basis that is considered a safe level. (TR49)

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