Establishing Acceptance Limits for Uniformity of Dosage Units: Part 3

Published on: 
Pharmaceutical Technology, Pharmaceutical Technology-05-02-2018, Volume 42, Issue 5
Pages: 34–44

The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.

Part one of this article introduced the concept of sampling distribution of acceptance value (AV) in uniformity of dosage units (UDU) (1). With different sample sizes such as n= 10 and 30, their AV distributions will be different, resulting in different critical AV values (i.e., the values at the locations covering 95% of the distributions that are equal to, for example, 12.5 and 9.1 for n = 10 and 30, respectively). Such critical values will be employed as AV working limits rather than using the single compendial limit of not more than (NMT) 15 (2). 

Part two of this article described how to establish the corresponding acceptance limits for AV data for process validation batches as well as the typical characteristics of AV distributions. 




Submitted: February 22, 2018
Accepted: March 27, 2018

About the Author

Pramote Cholayudth is validation consultant to Biolab Co., Ltd. in Thailand. He is the founder and manager of PM Consult,

Article Details

Pharmaceutical Technology
Vol. 42, No. 5
May 2018
Pages: 34–44


When referring to this article, please cite it as P. Cholayudth, “Establishing Acceptance Limits for Uniformity of Dosage Units: Part 3,” Pharmaceutical Technology 42 (5) 2018.