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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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.

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

Biotechnology Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Prefilled Syringes/PFS Validation Quality Risk Management/QRM Sterile Processing Supply Chain Technology Transfer Vaccines Visual Inspection

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

Source: TR 45: Depth Filtration

Manufacturing Filtration Microbiology Validation Quality Risk Management/QRM Sterile Processing Technology Transfer

Product Changeover
Procedural steps taken for switching from the manufacturing of one product to another product. (TR29)

Source: TR 29: Validation: Cleaning

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing Technology Transfer

Minimum Acceptable Cycle (MAC)
The minimum cycle conditions (in terms of delivered minimum lethality or minimum time and temperature) that would be considered acceptable. (TR01) (TR61)

Source: TR 1: Validation: Moist Heat

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Sterile Processing Technology Transfer

Mixed Load
A load that contains multiple item item types representing various sterilization challenges. For example, some load items may have air removal challenges, while others pose a challenge due to their mass. (TR01)

Source: TR 1: Validation: Moist Heat

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Sterile Processing Technology Transfer

False Positive
A test result that is erroneously classified in a positive category (e.g., a viable microbial detection result when viable microorganisms are not present). (TR33)

Source: TR 33: Rapid Micro Methods

Biotechnology Manufacturing Microbiology Validation Sterile Processing Technology Transfer

False Negative
A test result that is erroneously classified in a negative category (e.g., the absence of a viable microbial detection result when viable microorganisms are present). (TR33)

Source: TR 33: Rapid Micro Methods

Biotechnology Manufacturing Microbiology Validation Sterile Processing Technology Transfer

Cycle Development
A series of activities performed for the purpose of defining or confirming the cycle parameters (e.g., time, temperature, pressure) necessary to ensure sanitization or sterilization. (TR61)

Source: TR 61: Steam in Place

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing Technology Transfer

Cycle Phases
A discrete series of sterilizer process steps (such as, heat-up, exposure and cool-down) performed sequentially that represent a complete sterilization cycle. (TR48)

Source: TR 48: Moist Heat Sterilizer Systems

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing Technology Transfer