Application of RSD graphics for content uniformity data in continuous process verification

This article focuses on introducing a control chart technique using relative standard deviation (RSD) statistics (i.e. RSD chart); in other words, a table of coefficients of variation for continuous process verification.

Relative Standard Deviation (RSD) bounds were used in content uniformity in the past (prior to 2007). Statistically, RSD is one of the few statistics that best describes the term “uniformity”. In a simulation study conducted by the author, the acceptance value (AV) and RSD distributions have a typical relationship where it was found that AV and RSD charts, when applied for continuous verification purposes (CPV), can be built simultaneously on the same graph frame to illustrate their common overlay view. Although the RSD calculation is much simpler, RSD graphs can also be applied to confirm the validity of AV graphs in the CPV exercise.

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Peer-reviewed research

Submitted: May 23, 2022
Accepted: June 8, 2022

About the Author

Pramote Cholayudth, [email protected], is the founder and director of PM Consult. He is an industrial pharmacist with over 40 years of experience. He is a guest lecturer on process validation for industrial pharmaceutical scientists organized by the FDA of Thailand.

Item Details

Pharmaceutical technology
Flight. 46, No. 7
July 2022
Pages: 44 to 47


Quote

When referencing this article, please cite it as P. Cholayudth, “Application of RSD Charts for Content Uniformity Data in Continued Process Verification,” Pharmaceutical technology 46(7) 44–47 (2022).

About Linda Jackson

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