Content uniformity sampling plan

Table 32.1 Content Uniformity sampling plan for smaller sample sizes (ni sample size, ki acceptability constant...

Using sampling plan 1, a single content uniformity result is obtained from each location in the V blender, with the following results. 

Figure 4 Sampling plans for the determination of product uniformity within the lyophilizer. (A) Uniformity of protein content for a product in vials. (B, Q Uniformity of residual moisture for a product in ampoules. The lyophilizer has eight shelves and each shelf holds 15 trays of product containers. Arabic numerals refer to the tray number and show the order in which the trays are loaded during filling. Roman numerals relate to the sealing sequences. The trays are unloaded by blocks 12, starting from tray 120. As the trays are sealed in twos, the first two trays subject to sealing are identified by the number I, the last two trays by the number VI. The trays from which samples are collected for analysis are shaded.

Analysis or Sample-Orientation. The formulation of requirements for Craitent Uniformity (CU) however is chosen the other way around. The pharmacopoeia has formulated in every detail, how the sampling plan has to be performed and what outcome will lead to rejection or approval of the batch investigated. These requirements are formulated analysis or sample-oriented. The requirements and the influence oti consumer s risks (the chance that the consumer gets a safe product) as well as on producer s risk (the chance that a batch is incorrectly rejected) can be derived from the procedure and laid down in the Operations Characteristic (OC). The chances of acceptance are of course dependent on quality characteristics of the investigated batch such as mean content, standard deviation of the assay and percentage outliers. The OC does not formulate quality specifications, but is only a listing of chances, either to reject or to accept, as a function of a quality characteristic. 

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