PDA Technical Glossary

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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Attribute Sampling
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)
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Critical Process (CP)
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.
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Defect
(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)
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Difficult-to-inspect Parenterals (DIP)
When the nature of the product or package lim­its the ability to perform a thorough inspection for particles. (TR79)
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Implants
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)
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In-Process Observations
Nonconformity (ANSI def.)
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)
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Nonconformity Classifications
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)
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Sampling Plan
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)
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Visible Particle Range
Particulate matter sized above the visible particle 70% probability of detection threshold are con­sidered in the visible range, typically >100-150 μm. (TR79)
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“As Marketed”
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)
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