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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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Right First Time
The percentage of the time that a manufacturing process step, batch record, or in-process or laboratory test is successfully completed on the first attempt. (TR88)

Source: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry

Manufacturing Microbiology Validation

Out-of-Level Result (Out-of-Limit Result)
Any unexplained deviation or result that failed to meet set levels for environmental monitoring and other utilities. (TR88)

Source: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry

Microbiology

Out-of-Specification Result
Any unexplained deviation or the failure of a pharmaceutical ingredient, drug substance, or drug product batch to meet any of its regulatory-release and shelf-life specifications. (TR88)

Source: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry

Combination Products Microbiology Validation

Continuous Improvement
Ongoing activities to evaluate and positively change products, processes, and the quality system to increase effectiveness. (TR88)

Source: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry

Combination Products GMP/Good Manufacturing Processes/cGMP Quality Risk Management/QRM

Correction
Repair, rework, or adjustment relating to the disposition of an existing deviation. (TR88)

Source: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry

Inspections Validation

Microbial Data Deviation
A microbial test result that deviates from approved specifications or in-process limits. (TR88)

Source:

Batch Record Review
Review by the quality control unit of the batch manufacturing record for accuracy and completeness and for absence of derivation from the approved manufacturing and testing processes. The batch record is inclusive of all in-process testing and release records for a batch. (TR88)

Source: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry

Manufacturing GMP/Good Manufacturing Processes/cGMP Inspections

Cross-Functional Team
An investigatory team, comprising representatives including QCU microbiologists, manufacturing, engineering, and maintenance personnel, and other appropriate SMEs, with the purpose of conducting a manufacturing investigation. (TR88)

Source: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry

Manufacturing Combination Products Microbiology

Error, Laboratory
A self-evident documented mistake that will bring the validity of a laboratory test into question. (TR88)

Source: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry

Microbiology Validation

Error, Manufacturing
A self-evident documented mistake that will bring the manufacturing process into question. (TR88)

Source: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry

Manufacturing Microbiology Validation

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: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry

Microbiology Validation Sterile Processing

Invalid Result
Laboratory test result confirmed to be invalid as determined by a laboratory investigation. (TR88)

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: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry

Combination Products Microbiology

Container Closure System (CCS)
The sum of packaging components (primary and secondary) and materials that together contain and protect a product.(TR86)

Source: TR 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing

Packaging Science

Contaminants (Contamination)
Any adventitiously introduced materials (e.g., chemical, biochemical, or microbial species) not intended to be part of the manufacturing process of the drug substance or drug product (16). The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or API [drug substance] during production [manufacture], sampling, packaging or repackaging, storage or transport (17).

Source: TR 60: Process Validation

GMP/Good Manufacturing Processes/cGMP Microbiology Validation

Continuous Manufacturing
At least two process unit operations conducted under predetermined control conditions without process interruptions, where real-time process controls (PATs) may be used to meet the process requirements.

Source: TR 60: Process Validation

GMP/Good Manufacturing Processes/cGMP Validation

Process Performance Qualification Protocol
A written plan preapproved by the quality unit that specifies critical steps, controls, and measurements. The process performance qualification protocol states how process performance qualification or other validation studies will be conducted, identifying sampling, assays, specific acceptance criteria, production equipment, and operating ranges. Results obtained for each study described in the protocol should be evaluated in an associated process validation report. (TR60)

Source: TR 60: Process Validation

GMP/Good Manufacturing Processes/cGMP Validation

Process Performance Qualification Report
A report approved by the quality unit that summarizes specific tests performed, compares the test results with the protocol acceptance criteria, and addresses deviations encountered during the study. (TR60)

Source:

Ongoing Process Verification (OPV)
A formal plan to assure the process remains in its validated state during routine (post-PPQ) production and the process remains in a state of control (2, 3). (TR60-3)

Source: TR 60-3: Process Validation: A Lifecycle Approach: Bio Drug Sub Mfg

GMP/Good Manufacturing Processes/cGMP Validation

Performance Indicator
An output variable or outcome that cannot be directly controlled but is an indicator that the process performed as expected. (TR60-3)

Source: TR 60-3: Process Validation: A Lifecycle Approach: Bio Drug Sub Mfg

Concurrent Process 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 testing of the drug substance batches (1, 17). (TR60-3)

Source:

Shape factor (SF)/Circularity
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)

Source: TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers

GMP/Good Manufacturing Processes/cGMP Packaging Science

Perimeter
Measured length of the outer edges of a particle.

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Rect A
The longest side length when a rectangle is constructed around the particle. (TR85)

Source: TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers

GMP/Good Manufacturing Processes/cGMP Microbiology Validation

Ready-to-sterilize (RTS)
Washed components supplied in a package suitable for sterilization prior to use with sterile injectable products. (TR85)

Source:

Subvisible particle
A particle with a size <100 µm in diameter. (TR85)

Source: TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers

Inspections

Aspect Ratio
The length of a particle or fiber divided by its width. (TR85)

Source: TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers

Manufacturing Inspections Packaging Science

Visible fiber
A fiber-like particle with an aspect ratio ≥5 and a length >300 µm. (TR85)

Source:

Inspections

Area
Measured surface area of a flat projection of a particle.(TR85)

Source: TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers

Combination Products Inspections

Visible particle
A particle with an aspect ratio of <5 and a length >100 µm. (TR85)

Source:

Feret Min and Max
Feret Min is the minimum distance between parallel tangents at opposing particle borders. Feret Max is the maximum distance between parallel tangents at opposing particle borders.

Source: TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers

Manufacturing GMP/Good Manufacturing Processes/cGMP Validation

Length
The measure of the distance along its longest axis. Light obscuration (LO). Analytical technique measuring the size and quantity of subvisible particles. (TR85)

Source: TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers

Manufacturing GMP/Good Manufacturing Processes/cGMP Validation

Deterministic Leak Test Method
A method in which the leakage event being detected or measured is based on phenomena that follow a predictable chain of events. In addition, the measure of leak detection is based on physicochemical technologies that are readily controlled and monitored, yielding objective quantitative data. (TR86)

Source: TR 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing

Packaging Science

Labeling
The process by which a label is affixed to a packaging component. (TR85)

Source: TR 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing

Packaging Science

Container Closure Integrity Test (CCIT)
A package leak test (either physicochemical or microbiological) that detects the presence of a package breach or gap. Some tests may also be able to identify the magnitude and/or location of the leak (the term container closure integrity test is synonymous with package leak test or package integrity test for the purposes of this TR). (TR86)

Source: TR 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing

Packaging Science

Destructive
A method in which a sample cannot be subsequently utilized in any other analytical method or processed to a final product. (TR86)

Source: TR 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing

Manufacturing GMP/Good Manufacturing Processes/cGMP

Nondestructive
A method in which a passing sample can subsequently be utilized in additional analytical methods or processed to a final product. (TR86)

Source: TR 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing

Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP

Maximum Allowable Leak Limit (MALL)
The greatest gap or leak rate that does not put product quality at risk (2). (TR86)

Source: TR 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing

GMP/Good Manufacturing Processes/cGMP Packaging Science

Probabilistic Leak Test Method
A method that is the converse of a deterministic leak test method, being stochastic in nature. Probabilistic tests rely on a series of sequential and/or simultaneous events, each associated with random outcomes described by probability distributions. (TR86)

Source:

Package integrity
Is the measure of the ability of the package to prevent product loss or maintain product sterility and the ability to maintain the internal environment (2). (TR86)

Source: TR 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing

Inspections Packaging Science

Sterile/Microbial Barrier
The purported location on a container closure system beyond which no microorganism can pass under conditions qualified for the barrier. (TR86)

Source: TR 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing

Packaging Science

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)

Source: TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations

GMP/Good Manufacturing Processes/cGMP Packaging Science

Data Integrity Controls
Controls put in place to either minimize the potential for a data integrity issue to occur or, if an issue does occur, the controls applied to increase the probability of detection.(TR84)

Source: TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations

Packaging Science

Data Vulnerability
An indicator of data’s level of exposure to data integrity failures due to intrinsic weaknesses in manufacturing processes, data-capture technology, and human factors or a combination thereof.(TR84)

Source: TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations

GMP/Good Manufacturing Processes/cGMP Packaging Science

Gemba Walk
A method of walking through and personally observing processes. (TR84)

Source:

Data Process Flow Map
A flow map that uses a baseline process flow map and overlays the data flow. (TR84)

Source: TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations

GMP/Good Manufacturing Processes/cGMP Packaging Science

Mitigation
Systematic steps taken or in place to reduce or limit the identified risk. (TR84)

Source:

Quality Unit
An independent quality unit/structure with authority to fulfill certain pharmaceutical quality system responsibilities (7). (TR84) An organizational element within a pharmaceutical company with the authority and responsibility for quality as defined by 21 CFR 211.22 (11). The quality control unit typically comprises the quality control and quality assurance functions. (TR88)

Source: TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations

GMP/Good Manufacturing Processes/cGMP Packaging Science

Historian
A type of database designed to archive automation and process data. (TR84)

Source: TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations

GMP/Good Manufacturing Processes/cGMP Packaging Science

Looped Memory
An electronic system with limited storage capacity that overwrites older data when it reaches that capacity. (TR84)

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