Mapping Study Strategies in the Manufacturing Industry

Abstract

The following article is focused in strategies to conduct Mapping studies for the manufacturing industries. Mapping studies are used to document and control the distribution of environmental conditions in a determined space. These studies are performed by strategically placing sensors in equally distributed points to identify and eliminate if necessary critical points (cold/hot spots). This article will be focused on good manufacturing practices (GMP) and CFR 210 & 211. Also to present a strategy to the industry on the basics of mapping studies, describe the uses, outline possible study requirements guide. A mapping study was performed in a raw material warehouse. The study consist in monitoring static conditions for one (1) day and at dynamic conditions for seven (7) consecutive days by placing sensors strategically in the warehouse. Environmental conditions were monitored and results were successfully achieved. The maximum temperature and relative humidity recorded during the study was 76°F and 69%, complying with the required specification defined in this article. This means that the raw material warehouse complied with the intended use at the solid dosage pharmaceutical. Key Terms – Mapping Study, Environmental Distribution, Storage of Materials.