title: Regulatory considerations for the classification of video monitoring in dissolution testing.
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.
authors.affiliation: , Boston, Massachusetts, USA.
authors.forename: Kinh
authors.initials: K
authors.lastname: Tieu
authors.forename: Alger
authors.initials: A
authors.lastname: Salt
authors.forename: James
authors.initials: J
authors.lastname: Wirges
authors.forename: Geoffrey N
authors.initials: GN
authors.lastname: Grove
mesh_terms: D002138:Calibration; D002626:Chemistry, Pharmaceutical; D004867:Equipment Design; D005240:Feasibility Studies; D019983:Guideline Adherence; D017408:Guidelines as Topic; D007090:Image Interpretation, Computer-Assisted / Q000592:standards; D007700:Kinetics; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D015203:Reproducibility of Results; D012984:Software / Q000592:standards; D012995:Solubility; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods / Q000592:standards*; D014741:Video Recording / Q000145:classification / Q000295:instrumentation / Q000592:standards*
chemical_list: D004364:Pharmaceutical Preparations