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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Secondary Packaging Component
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)
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Shipper
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)
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Shipping
The transit of any material by land, sea, or air from one site to another. This may include intraplant movements. (TR39)
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Stability Profile
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)
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Storage Temperature
The temperature range listed on the medicinal product label specified for long term storage. (TR39)
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Supply Chain
The process by which a drug product is shipped and distributed from the manufacturer to the end user. (TR39)
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Supply Chain Optimization
The application of AI to enhance efficiency, stability, and visibility across the pharmaceutical supply chains, from manufacturing to distribution. An early application of AI was to calculate the most effective route of delivery to several destinations to enable products to be in transit for as short a time as possible and thus support product stability, cost, and sustainability.