ABSTRACT
Sampling is widely used in the biotech industry for various purposes, such as assessment of the quality of raw materials, intermediate, and finished products; and integrity of product containers and closure. It can also be used for the purposes of process validation; assessment of manufacturing process efficiency, such as bioburden removal; and state of control of manufacturing environment. Sampling is an important tool for root cause analysis, including investigation of out-of-specification (OOS) results. As a key component of the current Good Manufacturing Practice (cGMP; FDA, 1995), sampling allows for inference of a batch, process, or environment based on a small fraction of samples or samples collected at selected time points and locations. A sampling plan is developed based on various considerations, including the objective of the sampling testing and consumer’s and producer’s risks. Validity of the conclusions drawn from such inference depends on whether the sample is representative. This chapter discusses various applications of sampling and associated statistical considerations.
