This article introduces a control chart technique using F statistic for continued process verification of oral solid dosage forms.
Two typical tests for oral solid dosage forms are dissolution and content uniformity. In continued process verification (CPV), there must be some kind of evaluation such that the validity of the two test data within the same CPV batch is demonstrated. One such evaluation tool is control charting using F data (i.e., F chart) to demonstrate that the consistency between dissolution and CU data is under statistical control.
Click here for a PDF of this article.Submitted: July 25, 2022
Accepted: Aug. 19, 2022
Pramote Cholayudth, cpramote2000@yahoo.com, is the founder and manager of PM Consult. He is an industrial pharmacist with more than 40 years of experience. He is a guest speaker on process validation to industrial pharmaceutical scientists organized by Thailand’s FDA.
Pharmaceutical Technology
Volume 46, Number 10
October 2022
Pages: 44–47
When referring to this article, please cite it as P. Cholayudth, " Application of F Charts in Continued Process Verification of OSD Forms," Pharmaceutical Technology 46 (10) 44–47 (2022).
Legal and Regulatory Perspectives on 3D Printing: Drug Compounding Applications
December 10th 2024This paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, considering regulatory compliance, business concerns, and intellectual property rights.