ABSTRACT
I. INTRODUCTION Many pharmaceutical and process-oriented companies are installing a manufacturing execution system (MES) to improve efficiencies, reduce cycle times, and facilitate manufacturing control processes. The primary areas in which the MES is implemented are in material preparation (in which raw materials and intermediates are weighed and prepared for use in the manufacture of specific products), processing (in which raw materials and intermediates are converted to products), and packaging (in which the final product presentation is assembled.) Since any of these functions potentially impact the identity, strength, quality, and purity of the products, these functions are regulated by good manufacturing practices (GMP) requirements defined in the Code of Federal Regulations (CFR), title 21, chapter I, parts 210 and 211. These GMP regulations require that the system used to control and support product manufacturing functions be validated. Herein is described an approach to the implementation and validation of a computer-based control system.
