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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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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

Formative Usability Evaluation

Observed actual or simulated use of early prototypes to help reliably identify product conceptspecific, use-related hazards that may have been missed by other methods. (TR73)

Source: TR 73: Prefilled Syringe User Requirements for Biotech Applications

Biotechnology Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Prefilled Syringes/PFS Validation Quality Risk Management/QRM Technology Transfer

Criticality

A classification of an item (e.g., process, equipment, parameter) that expresses the significance given to the impact of that item, and should therefore be controlled or monitored to ensure product quality, safety or efficacy. (TR54) A classification of an item (e.g., product, process, equipment, parameter) that expresses the significance given to the impact of that item, and should therefore be controlled or monitored to ensure product quality, safety or efficacy. (TR68)

Source: TR 54: QRM:Manufacturing Operations

Biotechnology Manufacturing Prefilled Syringes/PFS Validation Quality Risk Management/QRM Technology Transfer

Compounding

A process in which a bulk drug substance is combined with one or more excipients and/or another bulk drug substance to produce a drug product. (TR22) A process wherein bulk drug substance is combined with one or more excipients and/or another bulk drug substance to produce a drug product. (TR62) The preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner’s prescription, medication order, or initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice. Compounding includes the following: • Preparation of drug dosage forms for both human and animal patients • Preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns • Reconstitution or manipulation of commercial products that may require the addition of one or more ingredients • Preparation of drugs or devices for the purposes of, or as an incident to, research (clinical or academic), teaching, or chemical analysis • Preparation of drugs and devices for prescriber’s office use where permitted by federal and state law. (TR63)

Source: TR 22: Aseptic Process Simulation

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Prefilled Syringes/PFS Validation Quality Risk Management/QRM

Composite Membrane

A membrane consisting of multiple layers. (TR15)

Source: TR 15: Validation: TFF in Biopharmaceuticals

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Prefilled Syringes/PFS Validation Quality Risk Management/QRM

Component, Secondary

Element of the assembled prefilled syringe (plunger rod, backstop, or safety system) that interacts with the primary components and provides functionality to the delivery system. (TR 73)

Source: TR 73: Prefilled Syringe User Requirements for Biotech Applications

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Prefilled Syringes/PFS Validation Quality Risk Management/QRM

Component, Primary

Element of the assembled prefilled syringe (needle, plunger stopper and tip closure, or adhesive) directly in contact with the drug. (TR 73)

Source: TR 73: Prefilled Syringe User Requirements for Biotech Applications

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Prefilled Syringes/PFS Validation Quality Risk Management/QRM