Robert Holt, PhD, associate director, Pharmaceutical Science, digiM Solution, discusses microstructure intelligence in more detail in part 2 of this preview of the company’s keynote presentation at AAPS PharmSci 360.
News|Articles|August 2, 2017
- Pharmaceutical Technology-08-02-2017
- Volume 41
- Issue 8
Establishing Acceptance Limits for Uniformity of Dosage Units: Part Two
Author(s)Pramote Cholayudth
The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.
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Abstract
The concept of sampling distribution of acceptance value (AV) was introduced in
Peer-review article
Submitted: Jan. 17, 2017
Accepted: March 8, 2017
About the author
Pramote Cholayudth is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM Consult, [email protected].
Article Details
Pharmaceutical Technology
Vol. 41, No. 8
Pages: 30–39
Citation:
When referring to this article, please cite it as P. Cholayudth, "Establishing Acceptance Limits for Uniformity of Dosage Units: Part Two," Pharmaceutical Technology 41 (8) 2017.
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