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This paper describes how the concept of acceptance value can be redefined to remove bias and more closely reflect quality targets.
The method currently used to ensure the uniformity of dosage units can result in bias and may allow batches of inferior quality to be released. The bias can result in fluctuated conclusions, especially when guidance established by the American Society for Testing and Materials’ (ASTM) E2810 standard guide is followed. Studies have found lack of correlation between AV and probability (ASTM E2810) computed using validation data. This inconsistency is caused by the conditional determination criteria that are used to determine the reference value. The concept of acceptance value must be redefined to remove bias and more closely reflect quality targets. This paper describes how this can be done.
for a PDF of the article.
Submitted: June 12, 2018
Accepted: July 20, 2018
Pramote Cholayudth is validation consultant to Biolab Co., Ltd. in Thailand. He is a guest speaker on process validation to industrial pharmaceutical scientists organized by local regulatory authorities. He is the founder and manager of PM Consult and can be contacted via email@example.com.
Vol. 42, No. 11
Pages: 30–39, 45
When referring to this article, please cite it as P. Cholayudth, “Uniformity of Dosage Units, Part 1: Acceptance Value” Pharmaceutical Technology 42 (11) 2018.