Establishing Acceptance Limits for Uniformity of Dosage Units: Part Two
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.
Africa Studio/shutterstock.com
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.
Click here to view a PDF of this article.
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.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
