Abstract
Background and objectives: The quality and efficacy of the pharmaceutical medicinal product are of paramount importance to the patients. Reproducibility and consistency of the properties of the dosage form start with the constituting ingredients either active or inactive. The present work provides an approach for the trending of one of the crucial inspection characteristics of a well-known excipient that is commonly used as a disintegrant of a water-insoluble synthetic cross-linked Polyvinyl Pyrrolidone (PVP). Establishing manufacturing criteria and quality limits should be assessed from the beginning level of the project using exploratory process-behavior plots. Materials and Methods: This study involved an assay of the initial 16 batches of the manufactured 1-ethenyl pyrrolidine-2-one expressed as a dried substance using a standard analysis method according to British Pharmacopoeia (BP). Exploratory Shewhart charts were plotted after preliminary distribution identification using Statistical Process Control (SPC) software. Based on the goodness of fit test results, the most appropriate assumed distribution was implemented in drawing the Individual/Moving Range (I/MR) control charts. Results: The goodness of fit study and probability plot showed that the most close-fitting to the data dispersion pattern was Johnson transformation to the normal spreading, smallest extreme value and Weibull distribution, respectively. While there were no alarms that could be detected from the process mean and the variability charts, further improvement is required from the supplier side to meet the benchmark minimum limit threshold, in addition, the process mean was not centered but shifted towards the Upper Control Limit (UCL). Conclusion: Implementation of SPC techniques is crucial in the modern competitive healthcare industry. Trending charts play a pivotal role in this perspective. They provide a quantitative estimation for the current situation and the actions needed for the future improvement of the monitored characteristic. Peer Review History: Received: 11 August 2023; Revised: 23 September; Accepted: 29 October, Available online: 15 November 2023 Academic Editor: Dr. Amany Mohamed Alboghdadly, Ibn Sina National College for Medical Studies in Jeddah, Saudi Arabia, amanyalboghdadly@gmail.com Received file: Reviewer's Comments: Average Peer review marks at initial stage: 6.5/10 Average Peer review marks at publication stage: 7.0/10 Reviewers: Dr. Taiwo O Elufioye, University of Ibadan, Nigeria, toonitaiwo@yahoo.com Dr. Bilge Ahsen KARA, Ankara Gazi Mustafa Kemal Hospital, Turkey, ahsndkyc@gmail.com
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