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

Aseptic Processing Area (APA)
Controlled environment, consisting of several zones, in which the air supply, facility, materials, equipment and personnel are regulated to control microbial and particulate contamination to acceptable levels. (TR22) (TR28) (TR62) (TR70)

Source: TR 22: Aseptic Process Simulation

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

Aseptic Processing Simulation (APS)
Aseptic Processing
Handling sterile materials in a controlled environment, in which the air supply, facility, materials, equipment and personnel are regulated to control microbial and particulate contamination to acceptable levels. (TR28) (TR62) (TR69) Handling of sterile product, containers, and/ or devices in a controlled environment in which the air supply, materials, equipment, and personnel are regulated to maintain (product) sterility. (TR13)

Source: TR 13: Environmental Monitoring

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

Anaerobe
Amplicon
A segment of double stranded DNA formed as the product of polymerase chain reaction or other amplification based techniques such as TMA or NASBA. (TR50)

Source: TR 50: Alt. Methods Mycoplasma Testing

Biotechnology Manufacturing Microbiology Packaging Science Validation Quality Risk Management/QRM Sterile Processing