This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
News|Articles|October 2, 2022
- Pharmaceutical Technology, October 2022
- Volume 46
- Issue 10
- Pages: 44–47
Application of F Charts in Continued Process Verification of OSD Forms
Author(s)Pramote Cholayudth
This article introduces a control chart technique using F statistic for continued process verification of oral solid dosage forms.
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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.
Peer-reviewed research
Submitted: July 25, 2022
Accepted: Aug. 19, 2022
About the author
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.
Article details
Pharmaceutical Technology
Volume 46, Number 10
October 2022
Pages: 44–47
Citation
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).
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Reformulating Successabout 4 years ago
Analyzing Extractables and Leachables in Single-Use Systemsabout 4 years ago
Improving Sterility Using Blow-Fill-Seal Technologyabout 4 years ago
Electrochemistry for API Synthesisabout 4 years ago
Shining a Light on Lipid Nanoparticle Characterizationabout 4 years ago
The Future of Drug Delivery for Biopharmaceuticalsabout 4 years ago
The State of Contamination Controlabout 4 years ago
Biologic Standards in the Pharmacopoeias: An Updateabout 4 years ago
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