
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 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (5)
- TR 55: TBA/TCA Detection Mitigation (4)
- TR 54: QRM:Manufacturing Operations (3)
- TR 54-2: QRM: Packaging Labeling (3)
- TR 57: Analytical Method Validation (3)
- TR 58: Temp Controlled Distribution (3)
- TR 44: QRM: Aseptic Processes (3)
- TR 54-4: QRM: Biotech Drug Substance (2)
- TR 68: Drug Shortage Management (2)
- TR 30: Parametric Release (2)
- TR 47: Virus Spikes/Virus Clearance (1)
- TR 51: Biological Indicators (1)
- TR 54-3: QRM: Drug Products (1)
- TR 56: Phase Appropriate cGMP Application (1)
- TR 57-2: Analytical Method Development (1)
- TR 60: Process Validation (1)
- TR 61: Steam in Place (1)
- TR 62: Manual Aseptic Processes (1)
- TR 69: Bioburden/Biofilm Management (1)
- TR 70: Cleaning/Disinfection Programs (1)
- TR 74: Reprocessing of Biopharmaceuticals (1)
- TR 13: Environmental Monitoring (1)
- TR 14: Validation: Protein Purification Chromatography (1)
- TR 22: Aseptic Process Simulation (1)
- TR 26: Sterilizing Filtration of Liquids (1)
- TR 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (1)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (1)
- TR 43: Glass Defects (1)
- TR 45: Depth Filtration (1)
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Bioburden
The total number of microorganisms per unit of material prior to sterilization. (TR13) Total number of viable microorganisms on or in a health care product prior to sterilization. (TR22)(TR61)(TR62) A population of viable microorganisms in a fluid prior to sterilizing filtration. (TR26) A measure of the contaminating organisms found in or on a given amount of material before it undergoes a sterilization process. (TR45) (TR70) The number of detectable microorganisms (bacteria and fungi) with which an object is contaminated. It is measured in CFU (colony forming units). (TR47) The number of viable, contaminating microorganisms present on a product immediately prior to decontamination. (TR51) Viable microbial contaminants associated with personnel manufacturing environments (air and surfaces), equipment, product packaging, raw materials (including water), in-process materials, and finished products. (TR 67) (TR 69)
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Drug Substance (DS)
The active ingredient that is subsequently formulated with excipients to produce the drug product. It can be composed of the desired product, product-related substances, and product- and process-related impurities. It may also contain excipients, including buffers and other components. [Synonyms: bulk drug substance, bulk material, active pharmaceutical ingredient (API)] (TR14) (TR57) (TR74) (TR60)
Active pharmaceutical ingredient in a drug product that is responsible for that product’s therapeutic activity.(TR67) (TR82) (TR88)
See Active Pharmaceutical Ingredient (API). (TR56)
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Excipient
A component of a drug formulation that has no active pharmacologic function. Excipients are commonly used in drug formulations as modulators of pH or osmolality for parenteral administration and as stabilizers for APIs. (TR54-4)
An ingredient added intentionally to the drug substance that should not have pharmacological properties in the quantity used. (TR57)
Inactive pharmaceutical ingredients in a product formulation that are responsible for the product’s manufacturability and physicochemical attributes. (TR67) (TR88)
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FDA Form 483
Inspectional observation sheet used by FDA investigators to document their findings. (TR67)
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Over-the-Counter (OTC) Drug Products
Drug products sold in drug stores directly to customers without a physician’s prescription. (TR67)
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Plant Utilities
Utilities include pharmaceutical-grade water systems, compressed gases, pharmaceutical-grade air systems, heating, ventilation and air conditioning systems, and space pressurization. (TR67)
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Product Related
A microorganism that can adversely affect the appearance, physicochemical attributes or therapeutic effect of a nonsterile product. (TR67)
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Quality Risk Management (QRM)
A systematic process for the assessment, control, communication, and review of risk to the quality of the drug product across the product lifecycle.(TR43)(TR54-2)(TR54-3)(TR57)(TR67)(TR68)
Documentation to prove that an installation/ equipment/process is designed and/or tested according to predefined specifications. Documentation may include Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).(TR58)
A systematic process for the assessment, control, communication, and review of risks to the quality of the drug (medicinal) product across the product lifecycle.(TR 54-5)(TR 76)(TR88)
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Risk
The combination of the probability of occurrence of harm and the severity of that harm.(TR30) (TR44) (TR54) (TR54-2) (TR54-4) (TR58) (TR67) (TR68) (TR88)
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Risk Assessment
A systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of identification of hazards and the analysis and evaluation of risk associated with exposure to those hazards. (TR30) (TR44) (TR54) (TR58) (TR55) (TR67) (TR57-2) (TR54-5) (TR88)
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Risk Management
The systematic application of quality management policies, procedures and practices to the tasks of assessing, controlling, communicating and reviewing risk. (TR44) (TR54) (TR54-2) (TR55) (TR67) (TR54-5)
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Risk Mitigation
Active systematic steps taken to reduce or limit risk. (TR55) (TR67)
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Route of Administration
The way in which a drug product or medical device is delivered based on the dosage form and therapeutic use. (TR67)
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Specified Microorganisms
Microorganisms with limit tests for absence in 1 or 10 g of a drug product, as described in USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms and USP <1111> Microbiological Quality of Nonsterile Pharmaceutical Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use. (TR67)
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Warning Letters
Type of correspondence that notifies a regulated industry about violations that FDA has documented during its inspections or investigations. (TR67)
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Water Activity (Aw)
Water Activity, Aw is the ratio of the vapor pressure of water in a product (P) to the vapor pressure of water in a product (P) to the vapor pressure of pure water (Po) at the same temperature. It is numerically equal to 1/100 of the RH generated by the product in a closed system. It is a measure of the free or available moisture in the material. Note: Water activity ≠ water content. RH can be calculated from direct measurements partial vapor pressure or dew point, or from indirect measurements by sensors whose physical or electric characteristics are altered by the RH to which they are exposed. Microorganisms need available water within a pharmaceutical product, as well as nutrients and minerals, to proliferate. Water activity, and not water content, is a better measure of the free water, in contrast to bound water that microbial cells require for metabolic activity and osmotic regulation. Effects of reduced Aw on microbial growth include a longer lag phase, slower growth rate, lower numbers of organisms in the stationary phase, and reduced microbial toxin production; below a specified Aw for an organism, microbial growth will not occur. (TR55) (TR67)