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

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)

Source: TR 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging

Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Packaging Science Validation Quality Risk Management/QRM Sterile Processing

Biomethylation
The enzyme chlorophenol o-methyltransferase responsible for fungal methylation has been isolated in cell-free extracts. Biomethylation, in this context, may be seen as a detoxification mechanism, although it plays a role in the production of mycotoxins by secondary metabolism. Slightly xerophilic fungi frequently associated halophenol biomethylation include Trichoderma longibrachiatum, Trichoderma virgatum, Aspergillus sydowii, and Penicillium islandicum. (TR55)

Source: TR 55: TBA/TCA Detection Mitigation

Virus Biotechnology Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Inspections Microbiology Quality Risk Management/QRM Sterile Processing Vaccines

Aseptic Processing Simulation (APS)
Airlock
Air Removal Test
A test used to evaluate air removal and steam penetration in an empty sterilizer that is used for porous/hard goods load sterilization (e.g., Bowie-Dick Test, DART, Lantor Cube, Browns’ Test). (TR01) (TR 48)

Source: TR 1: Validation: Moist Heat

Biotechnology Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing

Aggregation
Clumping of proteins, viruses, or bacteria that may arise from several mechanisms and may be classified in numerous ways, including soluble/insoluble, covalent/noncovalent, reversible/irreversible, and native/denatured. (TR47)

Source: TR 47: Virus Spikes/Virus Clearance

Virus Biotechnology Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Inspections Microbiology Quality Risk Management/QRM Sterile Processing Vaccines

Adverse Trend
A series of alert-level or action-level excursions that indicates the system or areas are not in control and have the potential to affect the product quality. (TR 70) An increase in the frequency of alert- and action-level excursions or repeated recovery of low levels of microorganisms below the alert level during microbial monitoring or of pharmaceutical ingredient or finished product failure that is indicative of a loss of process control. (TR88)

Source: TR 70: Cleaning/Disinfection Programs

Virus Biotechnology Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Inspections Quality Risk Management/QRM Sterile Processing

Adverse Event (AE) Report
An AE report is a communication to the U.S. FDA of an undesirable sign or symptom associated with use of a drug as required and detailed by 21 CFR 314.80. These reports are logged into the U.S. FDA’s Adverse Event Reporting System (AERS). Drug manufacturers are required to report adverse event information to FDA. These reports may also may be voluntarily submitted to the FDA directly by healthcare professionals or the general public at Med Watch. The reports are reviewed, safety issues are monitored, and data are periodically analyzed and assessed by the Center for Drug Evaluation and Research (CDER). (TR55)

Source: TR 55: TBA/TCA Detection Mitigation

Virus Biotechnology Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Inspections Microbiology Quality Risk Management/QRM Sterile Processing Vaccines