
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 22: Aseptic Process Simulation (8)
- TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations (7)
- TR 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (7)
- TR 60: Process Validation (5)
- TR 62: Manual Aseptic Processes (5)
- TR 69: Bioburden/Biofilm Management (5)
- TR 43: Glass Defects (5)
- TR 70: Cleaning/Disinfection Programs (4)
- TR 49: Validation: Cleaning Biotech (3)
- TR 54-4: QRM: Biotech Drug Substance (3)
- TR 55: TBA/TCA Detection Mitigation (3)
- TR 57: Analytical Method Validation (3)
- TR 63: Clinical Trials Material Preparation (3)
- TR 66: Single-Use Systems (3)
- TR 73: Prefilled Syringe User Requirements for Biotech Applications (3)
- TR 1: Validation: Moist Heat (3)
- TR 15: Validation: TFF in Biopharmaceuticals (3)
- TR 26: Sterilizing Filtration of Liquids (3)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (3)
- TR 28: Process Simulation for Bulk API (3)
- TR 29: Validation: Cleaning (3)
- TR 45: Depth Filtration (3)
- TR 48: Moist Heat Sterilizer Systems (2)
- TR 50: Alt. Methods Mycoplasma Testing (2)
- TR 51: Biological Indicators (2)
- TR 52: Supply Chain GDP (2)
- TR 58: Temp Controlled Distribution (2)
- TR 13: Environmental Monitoring (2)
- TR 14: Validation: Protein Purification Chromatography (2)
- TR 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC) (2)
- TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers (2)
- TR 79: Particulate Matter Control in Difficult to Inspect Parenterals (2)
- TR 78: Particulate Matter in Oral Dosage Forms (2)
- TR 39: Cold Chain (2)
- TR 42: Validation: Protein Manufacturing (2)
- TR 46: Good Distribution: Last Mile (1)
- TR 54: QRM:Manufacturing Operations (1)
- TR 57-2: Analytical Method Development (1)
- TR 64: Temp Controlled Systems Qualification (1)
- TR 67: Objectionable Microorganisms (1)
- TR 74: Reprocessing of Biopharmaceuticals (1)
- TR 3: Validation: Dry Heat (1)
- TR 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing (1)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (1)
- TR 33: Rapid Micro Methods (1)
- TR 41: Virus Filtration (1)
Filter By Technical Report Keyword
- Manufacturing (53)
- Biotechnology (43)
- Quality Risk Management/QRM (34)
- Validation (31)
- Supply Chain (20)
- Inspections (18)
- Microbiology (16)
- Sterile Processing (15)
- Combination Products (13)
- Filtration (10)
- Visual Inspection (8)
- Technology Transfer (6)
- Prefilled Syringes/PFS (4)
- Outsourcing (2)
- Vaccines (2)
- Virus (1)
- Lyophilization (1)
Filter By Technical Report Category
Action Level (environmental monitoring)
An established microbial or non-viable particle level that, when exceeded, should trigger appropriate investigation and corrective action based on the investigation. (TR22)
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Action Limit
An internal (in-house) value used to assess the consistency of the process. The cause of the excursion should be investigated and documented and corrective action is generally required. Action limits are not specifications. (TR42)
An established internal (in-house) data-based value which is part of the control strategy and used to assess the consistency of the manufacturing process. An action limit excursion result in an investigation, identification of recovered isolates, root-cause analysis, assessment of a systemic failure and impact on product quality and patient safety. (TR69)
An established internal (in-house) data-based value that is part of the control strategy and used to assess the consistency of the manufacturing process. An action limit excursion result in an investigation, identification of recovered isolates, root-cause analysis, assessment of a systemic failure and impact on product quality and patient safety. (TR74)
A limit that, when exceeded, indicates a process is outside of its normal operating range. A response to such an excursion should involve a documented investigation and corrective actions based on the results of that investigation. (TR60)
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Action Plan
A written plan consisting of elements to be accomplished to achieve a specific result. The plan describes responsibility for each element and a target date for completion. (TR22)
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Aerobic Microorganism
A microorganism that utilizes oxygen as the final electron acceptor during metabolism; a microorganism that will grow primarily in the presence of oxygen. For the purpose of this report, this definition encompasses facultative anaerobes. (TR22) (TR62)
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Alert Level
An established microbial or nonviable particle level giving early warning of potential drift from normal operating conditions; not necessarily grounds for definitive corrective action but typically requires follow-up investigation. (TR13) (TR22) (TR69)
An established level that, when exceeded, is giving an early warning of a potential drift from normal operating conditions; while not necessarily grounds for definitive corrective action, it typically requires follow-up review. (TR 60)
An established microbial or nonviable particle level giving early warning of potential drift from normal operating conditions; not necessarily grounds for definitive corrective action, but typically requires follow-up investigation (3, 4, 7). (TR88)
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Alert Limit
An established internal (in-house) data-based value giving early warning of potential drift of manufacturing process from normal operating conditions and triggers appropriate follow-up investigations. Alert limits are always lower than action limits. (TR69)
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Alternative or Rapid Microbiological Method (RMM)
A novel, modern and/or fast microbiological testing method that is different from a classical or traditional growth-based method, such as agar-plate counting or recovery in liquid broth media. The alternative or rapid method may utilize instrumentation and software to manage the testing and resulting data, and may provide quantitative, qualitative and/or microbial identification test results. Automated technologies that utilize classical growth-based methods may also be designated as being novel, modern or rapid, based on their scientific principle and approach to microbial detection. The terms alternative, rapid microbiological method, rapid method and the acronym RMM are used interchangeably within this technical report. (TR33)
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Anaerobic Microorganism
A microorganism that does not utilize oxygen as the final electron acceptor during metabolism; microorganism that will grow only in the absence of oxygen. (TR62)(TR22)
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Aseptic Processing
Handling sterile materials in a controlled environment, in which the air supply, facility, materials, equipment and personnel are regulated to control microbial and particulate contamination to acceptable levels. (TR28) (TR62) (TR69) Handling of sterile product, containers, and/ or devices in a controlled environment in which the air supply, materials, equipment, and personnel are regulated to maintain (product) sterility. (TR13)
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Aseptic Processing Area (APA)
Controlled environment, consisting of several zones, in which the air supply, facility, materials, equipment and personnel are regulated to control microbial and particulate contamination to acceptable levels. (TR22) (TR28) (TR62) (TR70)
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Aseptic Processing Simulation (APS)
A means for establishing the capability of an aseptic process as performed using a growth medium. (TR22) (TR62)
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Assess the Effects of the Change
To evaluate the effects of a manufacturing change on the identity, strength, quality, purity, and potency of a drug product as those factors may relate to the safety or effectiveness of the drug product. (TR38)
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Attachment (Adhesion)
Discrete association of a microorganism with an animate or inanimate surface. (TR69)
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Attribute
A physical, chemical, or microbiological property or characteristic of an input or output material. (TR60)
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Attributes (Process Performance Attribute)
An output variable or outcome that cannot be directly controlled, but is an indicator that the process performed as expected.(Synonym - Process Performance Parameter) (TR60)
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Attributes (Quality Attribute)
A molecular or product characteristic that is selected for its ability to indicate the quality of the product. Collectively, the quality attributes define identity, purity, potency and stability of the product, and safety with respect to adventitious agents. Specifications measure a selected subset of the quality attributes. (TR60)
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Backstop (Finger Plate or Thumb Plate)
Feature that enhances the area to hold the syringe and is usually designed to avoid accidental removal of the plunger from the back. By design, it may also serve as a flange extender to facilitate holding of the syringe during injection. (TR 73)
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Bulk Packaged Product
Consists of solid, liquid, or frozen product in a bulk container configuration such as a bag, tank, or drum. The product may be in these container configurations between process steps or prior to filling into vials, ampoules, cartridges, or syringes. (TR39)
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Chamber Cold Spot
The location(s) within the load zone that achieves the lowest process lethality (F0) and/or the lowest distribution temperatures during the sterilization process. (TR01)
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Chamber Heat-Up Time
The elapsed time measured from the introduction of steam in the heat-up phase (“steam on”) to the point when the temperature of the heating medium within the chamber reaches the exposure temperature set point. (TR01)
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Chamber Leak Test
A test conducted to evaluate possible air infiltration to the chamber under vacuum. [Synonym: Vacuum Leak Test] (TR1) (TR48)
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Change Control
A formal program that describes evaluation and actions to be taken if a change is proposed or completed to facilities, materials, equipment, and/or processes used in the fabrication, packaging, and testing of drugs, or a proposed or completed change that may affect the operation of the quality or support systems. (TR22) (TR39) (TR52) (TR58) (TR64) (TR 70)
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Changeover
The steps taken for switching multiproduct equipment from the manufacture of one product to the manufacture of a different product. (TR29) (TR49)
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Class I Recall
A situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. (TR55)
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Class II Recall
A situation in which use of or exposure to a violative product or may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequence is remote.(TR55)
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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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Clean in Place (CIP)
The process of rinsing or washing of process components, as installed without removal, in order to remove or eliminate any contaminants. (TR45)
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Clean(liness)
The measurement for the level of particulates, microbes, or other extraneous substances on an item or surface. (TR 70)
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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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Clinical Protocol
A document, together with any amendments to it, that describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial. (TR63)
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Clinical Trial Material (CTM)
A drug or combination of drugs and/or excipients that are produced with the intent that it be used in a clinical trial, or that is released or otherwise authorized for use in such. This could, subject to appropriate regulatory approval, be an experimental medicine, a product with marketing authorization used in a clinical trial within or beyond the approved indication and/or any placebo articles produced for use in a clinical trial. (TR63)
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Clinician
A physician, psychiatrist, etc., who specializes in clinical work as opposed to one engaged in laboratory or experimental studies. (TR58)
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Closed System
An isolated system that has no interaction with its external environment, preventing contamination and release of the material contained.(TR28) (TR 66)
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Color Changing Unit (CCU)
The quantity of mycoplasma contained in the highest dilution of a test article that produces a color change in a pH-sensitive liquid medium (typically containing phenol red) within a specified time of incubation, used for end-point determination of growth. (TR50)
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Commissioning
A well planned, documented and managed engineering approach to the start-up and transfer of facilities, systems and equipment to the end-user that results in a safe and functional environment that meets established design and user requirement specifications. Commissioning precedes Qualification and includes three phases:
1. Inspection, testing, and regulation
2. Adjustment and setting of work
3. Functional testing (TR 3)
A prescribed number of activities designed to take equipment and systems from a static, substantially complete state to an operable state. (TR 48)
A well planned, documented, managed engineering approach to the start-up and turnover of facilities, systems, and equipment to the end-user, that results in a safe and functional environment that meets established design requirements and stakeholder expectations.(TR 54) (TR 54-5)
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Comparability
The quality or state of being suitable for comparison. FDA may determine that two products are comparable if the results of the comparability testing demonstrate that a manufacturing change does not affect identity, strength, quality, purity, or potency as they may relate to the safety or effectiveness of the product. (TR38)
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Comparability Protocol
A protocol submitted by an applicant under CFR 601.12(e) and 314.70 (g) that describes the specific tests and validation studies and acceptable limits to be achieved to demonstrate the lack of adverse effect for specified types of manufacturing changes on the identity, strength, quality, purity, and potency of the product as they may relate to the safety or effectiveness of the product. Any such protocols, or change to a protocol, shall be submitted as a supplement requiring approval from FDA prior to distribution of the product. The supplement, if approved, may justify a reduced reporting category for the particular change because the use of the protocol for that type of change reduces the potential risk of an adverse effect. (TR38)
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Comparability Study
An assessment of the similarities between the critical parameters and output results of two or more separate processes or methods. (TR50)
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Comparative Transfer
Transfer of a method that involves the analysis of a predetermined number of samples of the same lot by both the sending and the receiving unit. (TR 57-2)
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Compatibility
Proof that no adverse interaction between the filter and the process fluid has occurred. (TR26) A term used in relation to the non-reactivity of filter materials with the substance to be filtered. (TR45)
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Compendial Procedure
A method that is considered validated as published in one of the recognized compendia. (TR57)
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Complaint Files
(a) As defined by 21 CFR Part 211.198- Complaint Files. (b) A written record of each complaint shall be maintained in a file designated for drug product complaints. The file regarding such drug product complaints shall be maintained at the establishment where the drug product involved was manufactured, processed, or packed, or such file may be maintained at another facility if the written records in such files are readily available for inspection at that other facility. 1.The written record shall include the following information, where known: the name and strength of the drug product, lot number, name of complainant, nature of complaint, and reply to complainant .2.Where an investigation under 211.192 is conducted, the written record shall include the findings of the investigation and follow-up. The record or copy of the record of the investigation shall be maintained at the establishment where the investigation occurred in accordance with 211.180. (TR55)
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Concentration Factor
The ratio of the initial feed volume to the retentate volume. (TR15)
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Concentration Polarization
A phenomenon in which the concentration of retained solutes increases in the region adjacent to the membrane surface due to limitations in particle transport back into the bulk solution. (TR15)
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Concurrent Validation
Validation that occurs during manufacturing of drug substance for batches that can be released and used in a final drug product for commercial distribution based on thorough monitoring and heightened testing of the drug substance batches. (TR42)
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Container Closure Integrity (CCI)
The ability of a package to prevent product loss, to block microorganism ingress, and to limit entry of detrimental gases or other substances, thus ensuring that the product meets all necessary safety and quality standards.(TR76)
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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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Data Lake
A storage repository that holds, in a structured way, a vast amount of raw data, including metadata, in its native format until it is needed. (TR84)
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Data Process Flow Map
A flow map that uses a baseline process flow map and overlays the data flow. (TR84)