PDA Technical Glossary

The protection of patient and healthcare data from unauthorized access, use, disclosure, disruption, modification, or destruction.

The organization and formatting of data (elements), crucial for efficient data access, analysis, and integration across systems. Data structures play a critical role in the pharmaceutical industry in managing and analyzing diverse types of data including chemical structures, biological sequences, and clinical trial data. Applications include relational databases used to store structured data in tables with predefined schemas, enabling efficient querying and analysis of large datasets and specialized data structures such as molecular fingerprints and protein structures used to represent complex biological information in a computationally tractable format. Appropriately designed data structures allow pharmaceutical companies to optimize data management, facilitate data integration, and enhance data analysis capabilities to support drug discovery, development, and manufacturing processes.

The process of evaluating a machine learning model's performance using metrics such as accuracy, precision, recall, and F1 score. Effective model scoring ensures that predictions are valid and trustworthy.

Functionally equivalent substitution of an alternative SUS, for an existing SUS design providing a contingency or process improvement with equivalent process performance and product quality. The end user is responsible to evaluate and determine if appropriate quality requirements are met for their application. (TR66)

Agreeing in kind, amount; unchanged in character or condition. (TR38)

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)

The quality of product for which the percent of lots expected to be accepted (Pa) is 95.0. These values are found in Tables X-A-1 to X-R-1 in ANSI/ASQ Z1.4.(TR76)

Reduction of microbial contaminants to safe levels as judged by public health requirements for the specific country. (TR13) A significant reduction in bioburden, achieved in chromatography by the use of bactericidal agents, such as sodium hydroxide (NaOH), hydrochloric acid (HCl), ethanol (EtOH), and isopropanol (IPA). (TR14) The process of reducing microbial levels by treatment at less than defined sterilizing conditions. Typically water at 80 °C or a chemical treatment is used to perform sanitization of process components. (TR45) A process that reduces the number of viable microorganisms to a defined level. (TR61) (TR69)

A compound that will reduce the number of vegetative microorganisms to a safe level as determined by public health requirements. Normally a reduction of 103 in vegetative microorganisms is obtained. (TR70)

Steam that is at a temperature and pressure that corresponds to the vaporization curve of water. It is in a state of equilibrium between being a liquid and a gas, with no entrained liquid water. [Synonym: Dry Saturated Steam] (TR01) (TR48) (TR61)

A sterilization process, typically used for porous/hard goods loads, where the sterilizing medium is saturated steam. (TR01)

Studies used to assess sizing for the appropriate performance of filter media at increased process volumes. (TR45)

The process of decreasing the column volume. (TR38)

A small-scale process step that has been demonstrated to be representative of a production-scale operation. (TR14)

Studies used to select a particular type and grade of filter media. (TR45)

Substance of established quality and purity that is qualified against, and used instead of, the primary reference standard; typically used as a reference standard for routine laboratory analysis. (TR57-2)

A component that is not nor will not be in direct contact with the drug product (e.g., vial seals, overwraps, container labels). The purpose of secondary packaging is to identify, protect, market, and communicate information about the product. Examples of secondary packaging include labels, cartons/folding boxes, and leaflets. (TR39)

The ability of an AI system to improve its performance over time through experience without explicit human intervention. Self-learning AI adapts continuously, redefining its predictions, decision making, and behaviors based on new data and feedback. In drug manufacturing, self-learning models optimize processes, enhance efficiency, and drive innovation. For example, a model can autonomously incorporate new datasets from batch manufacture, release and/or stability testing to refine its training and improve predictive accuracy.

Consists of machine-assisted handling and pre­sentation of filled containers to allow for human visual inspection. (TR79)

Person(s) who direct and control a company or site at the highest levels with the authority and responsibility to mobilize resources within the company or site (TR54) (TR54-2)

Ability of a method to detect small changes in the quality attribute (e.g., changes in concentration or purity) being measured. (TR57-2)

Olfactory sensation, odor threshold and taste threshold or organohalogen. (TR55)

Device using constructional and dynamic means to create assured levels of separation between the inside and outside of a defined volume. [Synonym: Separative Device] (TR51)

Filtration through two or more filters of the same or decreasing pore size, one after the other. (TR26)

A measure of the possible consequences of a hazard. (TR44) (TR54) (TR54-2) (TR54-3)(TR54-4) (TR54-5)

Provides information on the roundness of a particle. The SF value is between 0 and 1, where 1, represents a circle. A is the area of the particle and p is the perimeter. (TR85)

Relative motion between adjacent layers of a moving liquid. (TR69)

The velocity gradient in a flowing fluid. This value is proportional to the average linear velocity and is inversely proportional to the channel height or diameter when the recirculation is in the laminar flow regime (most TFF applications). (TR15)

The time period during which a drug product is expected to remain within the approved shelf life specification, provided that it is stored under the conditions defined on the container label. (TR63)

An individual or company who tenders products for transportation. (TR39) The person or organization responsible for arranging transportation of goods with carriers and/or freight forwarders. (TR58)

The transit of any material by land, sea, or air from one site to another. This may include intraplant movements. (TR39)

A standardized reusable metal box used for safe, efficient and secure storage and movement of materials and products within a global containerized intermodal freight transport system. Intermodal implies that the container can be moved from one mode of transport to another without unloading and reloading. They are the main type of equipment used in intermodal transport, particularly when one of the modes of transportation is by ship. They can also be referred to as ISO containers because the dimensions have been defined by ISO. Other types of transportation containers can include truck trailers. (TR55)

An established route of transportation between a specific point of origin to a specific destination. More defined routes will consistently use the same combination and types of transportation vehicles and transfer procedures, but this may not be observed through all shipping lanes throughout the last mile. (TR46) Lane described by origin, transportation node(s) and destination in combination with the used transport mode(s) (truck, aircraft, etc.). (TR58)

Size-exclusion filtration occurs when a particle is too large to pass through the filter medium and is retained on the surface or within the depth of the filter. (TR45)

The ratio of the filtrate concentration of component i (Ci,f) to the bulk or feed concentration of component i (Ci,b) as in the following equation: S = Ci,f/Ci,b Where S = 1 for a freely passing solute, typically a low molecular weight solute S = 0 for a solute that is fully retained by the membrane [Synonym: transmission; product transmission] (TR15)

A means to quantify the ability to discern between signal and noise. According to the theory, there are a number of determiners of how a detecting system will detect a signal, and where its threshold levels will be. The theory can explain how changing the threshold will affect the ability to discern, often exposing how adapted the system is to the task, purpose or goal at which it is aimed. (TR55)

A significant body of information on the stability of the drug product is likely to exist after 5 years of commercial experience for new molecular entities, or 3 years of commercial experience for new dosage forms (TR38)

An individual part designed to perform a particular function when assembled into a single-use system. (TR66)

An engineered process equipment solution, most commonly assembled from components made using polymeric materials, which together create a system or unit operation designed for one time or campaign use. (TR66)

The SAT is a series of tests that are performed as part of commissioning after the unit has been installed in the final location. (TR48)

A technique which separates particles based on diameter. (TR41)

Plastic sheets often made of polyethylene and sometimes used in distribution/transportation warehouse and shipping systems to separate pallet loads of product. Slip sheets may be important due to the ability of polyethylene to concentrate TBA in proximity to product. (TR55)

A homogenous distribution of resin particles in a liquid. (TR14)

To mix resin particles in a liquid to achieve a homogenous liquid suspension. (TR14)

The chemical or microbiological materials left on process equipment after completion of process manufacturing, but before initiation of the cleaning process. (TR29)

To use sound energy to agitate particles; generally used to accomplish mixing or cleaning. (TR70)

In the context of this Technical Report, the technique is used for dispersing viruses by use of sound-wave energy. (TR47)

Virus that is closely related to the known or suspected virus (same genus or family), having similar physical and chemical properties as those of the observed or suspected virus. (TR41)

A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use. (TR14) A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use. Drug product and drug substance specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities (TR38) (TR57) A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use. Drug product and drug substance specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities (TR69) A list of tests, references to analytical procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a drug substance, drug product, or materials at other stages of its manufacture should conform to be considered acceptable for its intended use. “Conformance to specification” means that the drug substance and drug product, when tested according to the listed analytical procedures, will meet the acceptance criteria. Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as conditions of approval. (TR56) (TR74) A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use (17). (TR60-3)(TR88)

The ability of an analytical procedure to accurately measure or detect a target analyte in the presence of other components in the sample matrix. (TR50) The ability to assess unequivocally the analyte in the presence of components that may be expected to be present. Typically these might include impurities, degradants, matrix, etc. Lack of specificity of an individual analytical procedure may be compensated by other supporting analytical procedure(s). (TR57) The ability to detect a range of microorganisms, which demonstrate that the method is fit for its intended use. (TR33)