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Pharmaceutical Technology
Establishing Acceptance Limits for Uniformity of Dosage Units: Part Two
Author(s):
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 Part One of this article series. In Part Two, the author describes how to establish the corresponding acceptance limits for AV data for process validation batches, the typical characteristics of AV distributions, and finally, how to derive relevant constants for AV control charts in annual product review and continued process verification reports.
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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, cpramote2000@yahoo.com.
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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