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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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TR 69: Bioburden/Biofilm Management (1)

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TR 53: Stability Testing New Drug Products

Storage

The retention of pharmaceutical products in a location such as a warehouse; the storing of pharmaceutical products up until their point of use. (TR53)

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In-Use

In the hands of the end user who can be the health professional or the patient. In-Use refers to the time period where product is in the custody of the end user or health care professional. (TR53)

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Finished Materials

This term refers to items such as drug substances, drug products, finished product held in bulk before final packaging, and clinical trial materials that are likely to be stored for significant periods of time and are also subject to the risks of distribution. (TR53)

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Excursion

A temperature or humidity deviation from conditions such as those specified by product labeling or shipping specifications. (TR53) Measurement that exceeds an alert, concern, or action level/limit by either a discreet value or an increasing/decreasing trend. (TR69)

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Date of Manufacture

For small molecules, the date of manufacture of a drug product is considered to be the initial date that an active ingredient has been added during manufacturing. For biologics the date of manufacture can be determined in multiple ways and should be consistent with internal quality systems and the product license application. (TR53)

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Cycling

A study designed to stress test the product and provide specific information on its ability to withstand transient high and low temperature excursions during distribution and storage. Typically the study conditions are outside of ICH accelerated conditions.(TR53)

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