PDA Technical Glossary

Systems with active temperature control (e.g., air/sea freight containers, refrigerated trucks/cars). (TR39) System with active temperature control. It makes use of electricity or fuel for the compressor to maintain temperature. Examples include refrigerated trucks, temperature-controlled ocean containers, and active ULDs. (TR58) Actively powered system that uses electricity or other fuel source to maintain a temperaturecontrolled environment inside an insulated enclosure under thermostatic regulation (e.g., cold room, refrigerator, temperature-controlled truck, refrigerated ocean or air container). (TR64) (TR72) (Synonym: Active Temperature Controlled System)

Additional means used in combination with the basic transportation unit to maintain the required temperature during transport. Examples include active systems and passive systems. (TR39)

Consists of solid, liquid, or frozen product in a bulk container configuration such as a bag, tank, or drum. The product may be in these container configurations between process steps or prior to filling into vials, ampoules, cartridges, or syringes. (TR39)

World-wide organization that supports its membership in designing and developing effective pre-shipment packaging performance standards, guides, and best practices for product distribution. (TR39)

Documented verification that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based on the approved process method and specifications. (TR3) (TR14) (TR45) (TR42) (TR48) (TR61) (TR64) Transport tests of product or representative product that is conducted during actual transportation or distribution. (TR39) Documented evidence that provides a high de­gree of assurance that the equipment and/or system functions accurately and consistently according to predetermined specifications in its operating environment. (TR54-5) Documented verification that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based on the approved process method and specifications (17). (TR60-3)

A component that is (or may be) in direct contact with the dosage form. Some examples of primary components are glass vials, syringe barrels, bottles, rubber closures, and container or closure liners. (TR39)

Documented testing that demonstrates with a high degree of assurance that a specific process will meet its pre-determined acceptance criteria. (TR39) (TR58) (TR64)

A component that is not nor will not be in direct contact with the drug product (e.g., vial seals, overwraps, container labels). The purpose of secondary packaging is to identify, protect, market, and communicate information about the product. Examples of secondary packaging include labels, cartons/folding boxes, and leaflets. (TR39)

An individual or company who tenders products for transportation. (TR39) The person or organization responsible for arranging transportation of goods with carriers and/or freight forwarders. (TR58)

The transit of any material by land, sea, or air from one site to another. This may include intraplant movements. (TR39)

The physical, chemical, biological, and microbiological behavior of a drug substance or drug product as a function of time when stored under the defined environmental conditions of an approved protocol. (TR39)

The process by which a drug product is shipped and distributed from the manufacturer to the end user. (TR39)