Abstract
The goal of this article is to discuss the classification of video recordings and images when applied to dissolution testing in USP apparatus 1 and 2. Three use cases are presented. The first case presents the use and classification of video as RBE (review by exception) data under GAMP 5. The second case presents the use of video in formulation development in a research and development environment. The third case presents a feasibility study using readily available computer vision software to recognize and measure objects in the dissolution vessel, setting the groundwork for the use of image analysis as a quantitative tool. The classification of video as “electronic data”, requiring 21 CFR part 11 compliance, versus its classification as a RBE data under GAMP 5, likely depends upon its use case. Another goal of this article is to establish a position on the use of video monitoring technology as a tool for dissolution testing that is fit for purpose and compliant with regulations regarding video data management and information.
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Acknowledgments
No external funding supported this work. It was wholly supported by the individual companies with whom the authors are employed.
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Authors declare no conflict of interest in this work, in so far as this article endorses no particular brands in respect to others.
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Glossary of Terms
- ASTM
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American Society for Testing and Materials
- Camera calibration
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The process of establishing a relationship between camera pixels in an image and a real unit of length measurement. This allows captured images to be corrected for distortions due to such things are lens curvature.
- Computer vision
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A field of study and research that includes image (and video) capture, processing, and analysis.
- FDA
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Food and Drug Administration
- IQ/OQ/PQ
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Installation qualification/operational qualification/performance qualification
- NDA
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New drug application
- GxP
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An abbreviation of GMP, GLP, etc., which in turn stands for “Good Manufacturing Practices,” “Good Laboratory Practices,” etc.
- GAMP
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“Good Automated Manufacturing Practice” is a subcommittee within the ISPE (International Society for Pharmaceutical Engineering). It also refers to guide that they publish (see reference #4).
- QbD
-
Quality by design
- USP
-
United States Pharmacopeia
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Tieu, K., Salt, A., Wirges, J. et al. Regulatory Considerations for the Classification of Video Monitoring in Dissolution Testing. AAPS PharmSciTech 15, 1611–1618 (2014). https://doi.org/10.1208/s12249-014-0191-y
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DOI: https://doi.org/10.1208/s12249-014-0191-y