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.
(Please select "All" to restart a filtered Search)
Refine Results
Filter By Technical Report Number
- TR 54: QRM:Manufacturing Operations (1)
- TR 54-3: QRM: Drug Products (1)
- TR 60: Process Validation (1)
- TR 63: Clinical Trials Material Preparation (1)
- TR 70: Cleaning/Disinfection Programs (1)
- TR 74: Reprocessing of Biopharmaceuticals (1)
- TR 14: Validation: Protein Purification Chromatography (1)
- TR 60-3: Process Validation: A Lifecycle Approach: Bio Drug Sub Mfg (1)
- TR 81: Cell-Based Therapy Control Strategy (1)
- TR 29: Validation: Cleaning (1)
- TR 60-2: Process Validation: A Lifecycle Approach, Annex 1: Oral Solid Dosage/Semisolid Dosage Forms (1)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (1)
- TR 41: Virus Filtration (1)
- TR 42: Validation: Protein Manufacturing (1)
Filter By Technical Report Keyword
Filter By Technical Report Category
Active Pharmaceutical Ingredient (API)
Synonym: Drug Substance. (TR14) (TR42) A substance or mixture of substances that, when delivered in a finished drug product, directly affects the structure or function of the body. (TR54-4) Any substance or mixture of substance intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body. Note: also known as Drug Substance. (TR29) (TR56) (TR41) (TR54-3) (TR60) Any substance or mixture of substances intended to be used in the compounding of a drug preparation, thereby becoming the active ingredient in that preparation and furnishing pharmacological activity o other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans and animals or affecting the structure and function of the body. (TR63) (TR70) Any substance or mixture of substances intended to be used in the manufacture of a drug product, and that when used in the production of a drug, becomes an active ingredient in the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure and function of the body. (TR74)
Source:
Critical Process Parameter (CPP) or Critical Operational Parameter
A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality. (TR54) (TR54-4) (TR56) (TR54-5) (TR60-2) (TR5 6) (TR 81)
An input process parameter that should be controlled within a meaningful operating range to ensure that drug substance critical quality attributes meet their specifications. Although parameters with wide operating ranges may also impact product quality, they are generally easily controlled and not as likely to result in excursions that impact quality and are therefore low risk of occurrence. (TR60-3)