Establishing Acceptance Limits for Uniformity of Dosage Units: Part Two

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.