PDA Technical Glossary

A process that impacts a critical quality attribute of the intermediate, drug substance or drug product being manufactured and therefore should have established critical process parameters that can be monitored or controlled to ensure that the process produces the desired quality.

Particulate matter sized above the visible particle 70% probability of detection threshold are con­sidered in the visible range, typically >100-150 μm. (TR79)

Collimated lighting at right angle to the viewing direction, typically against a black or dark back­ground, which is useful during manual visual inspection to detect fine dispersions of small par­ticulate that scatter the light making them more detectable. (TR79)

Destructive reconstitution, dilution, transfer, clearing, solubilizing, filtration, screening, or sieving that allows a product to be visually exam­ined or evaluated microscopically to determine the presence, type, and size of foreign particulate contamination present within the product, con­tainer, or device. (TR79)

Particulate matter sized below the visible particle 70% probability of detection threshold are con­sidered in the sub-visible range, typically <100- 150 μm. (TR79)

Consists of machine-assisted handling and pre­sentation of filled containers to allow for human visual inspection. (TR79)

The likelihood of detecting a defective unit dur­ing an inspection process expressed as a prob­ability, quantitatively as a number (0–1) or as a percentage (0–100%). (TR79)

Powders are defined as a solid or a mixture of sol­ids in a finely divided state intended for internal or external use. Powders used as pharmaceutical dosage forms may contain one or more APIs and can be mixed with water for oral administration or injection. (TR79)

Particulate matter consists of mobile, randomly-sourced, extraneous substances, other than gas bubbles, that cannot be quantitated by chemical analysis due to the small amount of material that it represents and its heterogeneous composition. (TR79)

Data generated from visual inspection of a blind­ed set of seeded test containers that demonstrates the detection capability of human inspection. The test set is sometimes referred to as a “particle size threshold set,” where various foreign particu­late types in a gradation of sizes are examined to yield a statistically significant probability of de­tection percentage for each unit. This allows the determination of what types and sizes of particu­lates can be reproducibly detected in a specific product/container system. (TR79)

Implants are long-acting dosage forms that provide continuous release of an API for periods of months to years. They are administered by the parenteral route. For systemic delivery, they may be placed subcutaneously or, for local delivery, they can be placed in a specific region in the body. (TR79)

When the nature of the product or package lim­its the ability to perform a thorough inspection for particles. (TR79)

Consists of mechanical handling and presenta­tion of product containers combined with auto­mated inspection of the filled containers using image analysis and/or light obscuration. (TR79)

Term used to describe the state or appearance of the product during 100% or AQL visual in­spection (prior to labeling). As marketed refers to the product in-situ or the form in which it is distributed, for example clear liquid, lyophilized, powder, opalescent liquid, etc. (TR79)

Observations or findings that are found during the processing of a product or products.(TR76)

The nonfulfillment of intended usage requirements. The departure or absence of one or more quality characteristics from intended usage requirements. (TR76)

A departure of a quality characteristic from its intended level or state that occurs with a severity sufficient to cause an associated product or service not to satisfy its intended normal or foreseeable usage requirements. (TR76)

Inspection of glass containers after product filling. (TR43)

Absence of materials that would adulterate a product when inspected with the eyes. (TR70)

This indicates the number of units of product from each lot or batch which are to be inspected (sample size or series of sample sizes) and the criteria for determining the acceptability of the lot or batch (acceptance and rejection numbers). (TR43) The number of units of product from each lot or batch that need to be inspected (sample size or series of sample sizes) and the criteria for determining the acceptability of the lot or batch (acceptance and rejection numbers). (TR 76)

A unitless measure of the absorption of light of a given wavelength in media of a given path length. (TR41)

Observations or findings that are found during the processing of a product or products. (TR43)

Critical: A Nonconformity that is likely to result in personal injury or potential hazard to the patient. This classification includes any nonconformity that compromises the integrity of the container, and risks microbiological contamination of a sterile product. Major A: A Nonconformity leading to serious impairments, for example, a malfunction that makes the packaging unusable. Major B: A Nonconformity leading to impairments of a lesser degree, for example, reduced efficiency in production. Minor: A Nonconformity that does not impact product quality or process capability. N/A: An imperfection classification that is less than the size, magnitude and impact of a nonconformity is considered not applicable. Therefore an imperfection that is considered to be non-applicable is acceptable.(TR43) Critical: A nonconformity that risks personal injury or potential hazard to the patient. Any nonconformity that risks container closure in¬tegrity is assigned to this classification. Major A: A nonconformity leading to serious container impairments, e.g., a malfunction making packaging unusable. Major B: A nonconformity leading to contain¬er impairments of a lesser degree, e.g., reduced efficiency in production. Minor: A nonconformity that does not impact product quality or process capability. N/A: Imperfections that are considered to be nonapplicable or nondefects and are therefore acceptable.(TR 76)

A departure of a quality characteristic from its intended level or state that occurs with severity sufficient to cause an associated product or service not to meet a specification requirement. [Synonym: Defect] (TR43)(TR76)

(1) A departure of a quality characteristic from its intended level or state that occurs with a severity sufficient to cause an associated product or service not to satisfy its intended normal or foreseeable usage requirements. (TR51) (2) The nonfulfillment of intended usage requirements. The departure or absence of one or more quality characteristics from intended usage requirements. (TR43)

Inspection where either the unit of product is classified as conforming or non-conforming or the number of non-conformities in the unit of products is counted with respect to a given requirement of set of requirements. (TR43)