ABSTRACT
This chapter discusses microbiological issues and provides specific and practical applications for the validation of manufacturing processes for a marketed solid oral dosage form. The Center for Drug Evaluation and Research conducts an evaluation of stability data and approves proposed expiration dates. Validation protocols are developed from the information obtained during product development research. Another important variable in the manufacturing process is the tablet press or encapsulating machine. Many solid oral dosage forms are made by direct compression. The two types of mixers are low energy and high energy. The low-energy mixers represent the classical type of slow mixers, such as ribbon blenders, tumblers, and planetary pony pan; the high-energy mixers include some basic features of the low-energy mixers but also contain some type of high-speed blade, commonly termed an intensifier bar or chopper. Finished product testing, particularly assay, content uniformity, and dissolution, and should be carefully recorded.
