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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Plant Utilities
Utilities include pharmaceutical-grade water systems, compressed gases, pharmaceutical-grade air systems, heating, ventilation and air conditioning systems, and space pressurization. (TR67)
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Platform Manufacturing
Development of a production strategy for a new drug starting from manufacturing processes similar to those used to manufacture other drugs of the same type (the production for which there already exists considerable experience). (TR60)
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Platform-Based Method
Existing method based on the same basic principles and steps as a new method that is required and defined in the design/strategy phase; applies to multiple sample types and requires minimal changes or refinements based on specific product requirements. (TR57-2)
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Process
A series of operations and/or actions used to produce a desired result. (TR38)