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 22: Aseptic Process Simulation (4)
- TR 57: Analytical Method Validation (3)
- TR 58: Temp Controlled Distribution (3)
- TR 62: Manual Aseptic Processes (3)
- TR 26: Sterilizing Filtration of Liquids (3)
- TR 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC) (3)
- TR 47: Virus Spikes/Virus Clearance (2)
- TR 60: Process Validation (2)
- TR 64: Temp Controlled Systems Qualification (2)
- TR 70: Cleaning/Disinfection Programs (2)
- TR 14: Validation: Protein Purification Chromatography (2)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (2)
- TR 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (2)
- TR 33: Rapid Micro Methods (2)
- TR 42: Validation: Protein Manufacturing (2)
- TR 48: Moist Heat Sterilizer Systems (1)
- TR 50: Alt. Methods Mycoplasma Testing (1)
- TR 51: Biological Indicators (1)
- TR 52: Supply Chain GDP (1)
- TR 53: Stability Testing New Drug Products (1)
- TR 54: QRM:Manufacturing Operations (1)
- TR 55: TBA/TCA Detection Mitigation (1)
- TR 57-2: Analytical Method Development (1)
- TR 61: Steam in Place (1)
- TR 63: Clinical Trials Material Preparation (1)
- TR 66: Single-Use Systems (1)
- TR 71: Emerging Methods for Virus Detection (1)
- TR 74: Reprocessing of Biopharmaceuticals (1)
- TR 13: Environmental Monitoring (1)
- TR 15: Validation: TFF in Biopharmaceuticals (1)
- TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers (1)
- TR 79: Particulate Matter Control in Difficult to Inspect Parenterals (1)
- TR 78: Particulate Matter in Oral Dosage Forms (1)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (1)
- TR 39: Cold Chain (1)
- TR 41: Virus Filtration (1)
- TR 43: Glass Defects (1)
- TR 44: QRM: Aseptic Processes (1)
- TR 45: Depth Filtration (1)
Filter By Technical Report Keyword
- Manufacturing (32)
- GMP/Good Manufacturing Processes/cGMP (30)
- Quality Risk Management/QRM (20)
- Sterile Processing (20)
- Validation (17)
- Microbiology (13)
- Biotechnology (11)
- Packaging Science (6)
- Inspections (5)
- Supply Chain (5)
- Technology Transfer (5)
- Virus (4)
- Filtration (4)
- Outsourcing (3)
- Combination Products (2)
- Prefilled Syringes/PFS (2)
- Visual Inspection (2)
- Vaccines (1)
Filter By Technical Report Category
Filter By Artificial Intelligence
Artificial General Intelligence (AGI)
A highly advanced form of artificial intelligence with the capability to understand, learn, and apply knowledge across a broad range of tasks at a level comparable to human intelligence. In pharmaceutical applications, AGI could revolutionize drug discovery, development, and manufacturing by autonomously designing experiments, optimizing complex processes, interpreting vast amounts of scientific data, and even generating novel hypotheses.
Source:
Digital Dependability Identities
The unique attributes that ensure digital systems maintain reliability and resilience, including system availability, data accuracy, integrity, and security.
Source:
Health Informatics
The intersection of information science, computer science, and healthcare that involves the use of technology to store, manage, and analyze health-related information.
Source:
ISO/IEC
International Organization for Standardization/International Electrotechnical Commision. (TR52)
Source:
ISTA: International Safe Transit Association
World-wide organization that supports its membership in designing and developing effective pre-shipment packaging performance standards, guides, and best practices for product distribution. (TR39)
Source:
IT/OT (Information Technology/Operational Technology)
The merging of Information Technology (IT), which manages computing, networking, and data infrastructure, with Operational Technology (OT), which focuses on monitoring and automating physical processes. IT/OT integration enables seamless data exchange, process optimization, and enhanced system control for greater efficiency and regulatory compliance.
Source:
Identification
Use of an analytical procedure to determine the chemical and biochemical identity of a material. (TR57)
Source:
Identity Test
A technique used to determine or confirm the identity of an organism (virus, bacteria, cells). (TR47)
Source:
Impact Analysis
Determination of how a product failure may extend an investigation “to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy” (10). (TR88)
Source:
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)
Source:
Impurity
Any component present in the drug substance or drug product that is not the desired product, a product-related substance, or excipient including buffer components. It may be either processor product-related. (TR14) (TR57) (TR74)
Any component present in the drug substance or drug product which is not the desired product, a product-related substance, or excipient. It may be either process- or product-related (17). (TR60)
Source:
Impurity Profile
A description of the identified and unidentified impurities present in a drug substance (ICH A3A). (TR38)
Source:
In-Process Leachables
Chemicals substances that are leached, from product-contact or non-product-contact materials under typical process conditions and could be cleared or sufficiently diluted by downstream processes so as to be undetected as leachables in the final dosage. Alternate Terms: Transient Leachables, Migrant Leachable. (TR66)
Source:
In-Process Method (In-Process Control)
Checks performed during production to monitor and, if appropriate, adjust the process to ensure that the intermediate or active pharmaceutical ingredient conforms to its specifications. (TR57-2)
Source:
In-Process Observations
Observations or findings that are found during the processing of a product or products.(TR76)
Source:
In-Use
In the hands of the end user who can be the health professional or the patient. In-Use refers to the time period where product is in the custody of the end user or health care professional. (TR53)
Source:
In-Use Testing (also called In-Situ Testing)
A field study that validates the effectiveness of a disinfecting agent, the trained operators, and the approved operating procedures. (TR70)
Source:
Incident
Any event that occurs during the shelf life of a product that may have an adverse effect on quality (e.g., temperature excursion, missing temperature monitor when required, shipment time in excess of qualified packout duration, wet/ crushed packaging). (TR58)
Source:
Incident Management System
Part of the Quality Management System that handles incidents, deviations, excursions, and exceptions in the supply chain. (TR58)
Source:
Inclusivity
The ability of an assay to detect a target microorganism. (TR33)
Source:
Incoming Inspection
A preventative program where parts or products are subjected to evaluation upon receipt.(TR43)
A program where, upon receipt, parts or products are subjected to measuring, examining, testing, or gauging one or more characteristics of a product or service, and comparing the results with specified requirements in order to establish whether conformity is achieved for each characteristic.(TR 76)
Source:
Incoterms
International commerce terms. These are a series of international sales terms, published by the International Chamber of Commerce (ICC), and widely used in international commercial transactions. (TR58)
Source:
Independent Replicates
Two or more measurements or observations that are generated from independently prepared samples and do not affect each other. (TR57)
Source:
Indicator Cells
Cell lines that are used in in vitro assays to detect the presence of viral agents. (TR71)
Source:
Industry 4.0
The ongoing automation and digitization of traditional manufacturing and industrial practices to create "smart factories" that are more efficient, scalable, and interconnected. This includes integrating advanced technologies such as Internet of Things (IoT) sensors, artificial intelligence (AI) driven analytics, cloud computing, and cyber-physical systems. (Also known as the “fourth industrial revolution”.) In the pharmaceutical sector, Industry 4.0 enhances production efficiency, regulatory compliance, and product quality.
Source:
Infectious Unit
A measure of quantity of infectious virus. An infectious unit does not necessarily reflect the number of virus particles, as virus preparations also contain noninfectious virus particles and, depending on the cellular host, more than one virus particle may be necessary to infect a cell. (TR47)
Source:
Influent
Fluid that flows into a process step. [Synonym: feed.] (TR26)
Source:
Information
Processed and organized data used for meaningful decision-making. High-quality information enables pharmaceutical companies to optimize workflows, improve product quality, ensure regulatory compliance, and drive innovation through AI-driven insights.
Source:
Information-only Tests
Tests that provide data that are collected without pre-established acceptance criteria to further evaluate the process. (TR42)
Source:
Inlet Pressure
The applied pressure entering the upstream side of the filter. [Synonym: influent, upstream or line pressure] (TR26)
Source:
Inoculated Carrier
A carrier upon which a defined number of test organisms have been deposited. (TR51)
Source:
Installation Qualification (IQ)
Documented verification that the equipment or systems, as installed or modified, comply with the approved design, the manufacturer’s recommendations, and/or user requirements. (TR14) (TR42) (TR48) (TR61) (TR64)
The documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer’s recommendations. (TR54-5)
Documented verification that the equipment or systems, as installed or modified, comply with the approved design, the manufacturer’s recommendations, and/or user requirements (17). (TR60)
Source:
Integrity Test
Test to determine the functional performance of a membrane filter or container/closure system. (TR22) A nondestructive test used to predict the functional performance of a filter. (TR45) A nondestructive physical test that can be correlated to the bacterial retention capability of a filter/filter assembly. (TR26)
Source:
Integrity Testing
A method of determining if a membrane or filter is physically intact and free from gross defects. (TR15)
Source:
Intelligent Automation
The use of artificial intelligence, business process management, and robotic automation to streamline and scale decision-making across organizations. Intelligent automation solutions must include human oversight to ensure data security and privacy.
Source:
Intended Use/Intended Purpose
Use for which a product, process or service is intended according to the specifications, instructions and information provided by the manufacturer. (TR54)
Source:
Intermediate (or In-Process Material)
A material produced during the steps of the processing of an API that undergo further molecular change or purification before it becomes an API. Intermediates may or may not be isolated. (TR60)
Source:
Intermediate Material
The chemical mixture that may or may not have completed the chemistry steps, and thus is not in its final chemical and physical/conformational state, and has not been through final process steps to final drug substance. Examples in the small molecule world include isolated intermediates, intermediates, and final intermediates. Examples in the large molecule world include crude protein mixtures (pre-transformation, conversion, or folding) and purified protein prior to any final polishing steps. (TR38)
Source:
Intermediate Precision
The precision within the same laboratory using different analysts, equipment, reagents and/or on different days. (TR33)
Source:
Intermodal Container
A shipping container used to ship cargo through more than one of the four traditional modes of transportation (road, air, ocean, and rail). (TR64)
Source:
Internal Control
A reaction performed to provide confirmation of adequate performance of the NAT assay including preparation of nucleic acid, its amplification using appropriate amplification technology, and analysis of amplified products. An example is the amplification of a housekeeping gene from the production cell line which provides a positive signal even in the absence of contaminant DNA. (TR50)
Source:
Intervention
An aseptic manipulation or activity performed by personnel that occurs within the critical area. (TR22) (TR44) (TR62)
Source:
Intervention, Corrective
An intervention that is performed to correct or adjust an aseptic process during its execution. Examples include such activities as: clearing component misfeed, adjusting sensors, and replacing equipment components. (TR22) (TR62)
Source:
Intraperitoneal (i.p.)
Term defines when a chemical is administered through the peritoneal cavity (area that contains the abdominal organs). (TR55)
Source:
Intrinsic Particles
Those particles that arise from sources related to the formulation, packaging, or assembly processes. In each of these cases, the particle material (e.g., glass, stainless steel, rubber, or gasket material) could be identified as a known product-contact material. (TR78)
A particle that comes from within the primary process. These are qualified product contact materials and are often associated with the primary packaging components. They are unplanned but not unexpected.(TR85)
Source:
Invalid Test
Laboratory test that, as a result of the laboratory (Phase I) investigation, did not meet the test method requirements and whose results would not be deemed valid. This may also apply to a test which was aborted (e.g. breakdown of isolator during sterility testing). (TR88)
Source:
Investigator
A clinician scientist taking part in a clinical trial having direct and immediate clinical responsibility for the subject or patient and their treatment with the clinical trial material. (TR63)
Source:
Irradiation
The process by which an item is exposed to ionizing radiation (typically gamma) to reduce or eliminate bioburden. (TR41)
Source:
Isolated Intermediate
An intermediate that is obtained as the product after workup of a purification step in the process scheme for the drug substance. The isolation or purification procedure should be part of the validated process. An aliquot of a product that is worked up and/or purified for purposes of characterization does not constitute an isolated intermediate. (TR38)
Source:
Isolates
Microorganisms that are recovered from a facility. (TR70)