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

Aseptic Processing Simulation (APS)
A means for establishing the capability of an aseptic process as performed using a growth medium. (TR22) (TR62)

Source: TR 22: Aseptic Process Simulation

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

Airlock
A room that controls the airflow between two rooms of different classification. (TR 70)

Source: TR 70: Cleaning/Disinfection Programs

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

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