INTRODUCTION

The uncertainty around the application of the zero tolerance criterion (ZTC) to sample sizes larger than 30 may inhibit the collection of uniformity data from large samples. This chapter provides a process for limiting the number of observed results that fall outside of the ZTC (c₂), as described in Uniformity of Dosage Units 〈905〉, when samples larger than 30 are collected. It should be noted that the criterion described in this chapter is not intended as a batch release test, nor as a replacement of or alternative to 〈905〉. It also is not intended as an extension to go beyond second tier testing in 〈905〉. The use is solely to help judging if a large data set is consistent with the ZTC element of 〈905〉; whether the large data set complies with the complete set of requirements in 〈905〉 must be decided by other means.