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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 41: Virus Filtration (1)

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TR 79: Particulate Matter Control in Difficult to Inspect Parenterals GMP/Good Manufacturing Processes/cGMP

Manual Inspection

Consists of manual handling and presentation of filled containers under controlled conditions of lighting and background to allow for human visual inspection. (TR79)

Source: TR 79: Particulate Matter Control in Difficult to Inspect Parenterals

GMP/Good Manufacturing Processes/cGMP Inspections Microbiology

Tyndall Lighting

Collimated lighting at right angle to the viewing direction, typically against a black or dark background, which is useful during manual visual inspection to detect fine dispersions of small particulate that scatter the light making them more detectable. (TR79)

Source: TR 79: Particulate Matter Control in Difficult to Inspect Parenterals

Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Inspections Microbiology Visual Inspection

Implants

Implants are long-acting dosage forms that provide continuous release of an API for periods of months to years. They are administered by the parenteral route. For systemic delivery, they may be placed subcutaneously or, for local delivery, they can be placed in a specific region in the body. (TR79)

Source: TR 79: Particulate Matter Control in Difficult to Inspect Parenterals

Manufacturing GMP/Good Manufacturing Processes/cGMP Inspections Packaging Science Visual Inspection

Difficult-to-inspect Parenterals (DIP)

When the nature of the product or package limits the ability to perform a thorough inspection for particles. (TR79)

Source: TR 79: Particulate Matter Control in Difficult to Inspect Parenterals

Manufacturing GMP/Good Manufacturing Processes/cGMP Packaging Science Visual Inspection

Automated Inspection

Consists of mechanical handling and presentation of product containers combined with automated inspection of the filled containers using image analysis and/or light obscuration. (TR79)

Source: TR 79: Particulate Matter Control in Difficult to Inspect Parenterals

GMP/Good Manufacturing Processes/cGMP Inspections Microbiology Visual Inspection

GMPs

Best practices in manufacturing of pharmaceuticals or biopharmaceuticals. From a regulatory standpoint, GMPs are regarded as the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packaging, or holding of a drug to assure that such drug meets requirements of safety, identity and strength and meets the quality and purity characteristics that it purports or is represented to possess. (TR41) (TR 79)

Source: TR 41: Virus Filtration

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP