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.
(Please select "All" to restart a filtered Search)
Refine Results
Filter By Technical Report Number
Filter By Technical Report Keyword
Filter By Technical Report Category
Acceptance Limit
The maximum amount of residue allowed in a product, in an analytical sample, or as an amount per surface area. (TR29)
Source:
Cleaning Validation
Documented evidence with a high degree of assurance that a cleaning process will result in products meeting their predetermined quality attributes throughout its life cycle. (TR29)(TR49)
Source:
Cleaning Verification
A one-time sampling and testing to ensure that specified equipment has been properly cleaned following a specific cleaning event. (TR29) (TR49)
Source:
Coupon
A small, generally flat portion of a defined material of construction (such as stainless steel or PTFE) and of a defined surface finish, typically used for laboratory cleaning evaluations and/or for laboratory sampling recovery studies. (TR29) (TR49)
Source:
Dedicated Equipment
Equipment used exclusively for the manufacture of only one drug product, bulk drug substance, or intermediate. (TR29)
Source:
Dirty Hold Time
The time from the end of product manufacturing until the beginning of the cleaning process (also called “soiled hold time”). (TR29)
Source:
Free Drained Equipment
No visible water pool in the equipment or line when viewed under appropriate lighting conditions (but may contain water droplets). (TR29)
Source:
Grouping Strategy
A strategy for establishing similar cleaning processes, usually based on similar products or similar equipment, and to validate the cleaning process based primarily on validation data for a representative of the group. (TR29) (TR49)
Source:
Limit
A value for a residue above which a cleaning process would not be acceptable. (TR29) A value for a residue above which a cleaning validation protocol would fail. (TR49)
Source:
Mock Soil
A soil which is used in place of the manufactured product during a cleaning validation protocol (also called a “surrogate” soil). (TR29)
Source:
Mock Soiling
A process of soiling the equipment for a cleaning validation protocol in which soil is applied to the equipment surfaces to simulate the condition of the soil on those surfaces following typical product manufacturing. (TR29)
Source:
Normal Dose
The therapeutic dose of a product as given on the approved product labeling. (TR29) (TR49)
Source:
Product Changeover
Procedural steps taken for switching from the manufacturing of one product to another product. (TR29)
Source:
Recovery Study
A laboratory study combining the sampling method and analytical method to determine the quantitative recovery of a specific residue for a defined surface. (TR29) A laboratory study combining the sampling method and analytical method to determine the quantitative recovery of a specific residue for a defined surface. (TR49)
Source:
Worst Case Soil
A soil that is the most difficult to clean from production equipment based on knowledge generated from laboratory studies, scientific properties, and/or production experience. (TR29)
Source:
Worst-Case Process Condition
A condition or set of conditions encompassing upper and/or lower processing limits and circumstances, within standard operating procedures, which pose the greatest chance of product or process failure when compared to ideal conditions (such conditions do not necessarily induce product or process failure). (TR29)