Due to globalization, restructuring of organizations, and the emergence of fast-paced technologies, companies need to endorse efficient and effective methods of performing validation. This is especially true when establishing a defendable environmental sampling plan (performance qualification phase), since there is a higher probability for the FDA or other regulatory agencies to scrutinize the documentation process during inspection when companies attempt to obtain licensure of their facility for the manufacture of their products1.
This article is the first in a three-part series describing an engineering approach to establishing an environmental sampling plan for a new pharmaceutical or biopharmaceutical manufacturing facility. The series assume the facility has just been built and no manufacturing of batches have been run, despite being associated with other corporate sites. Simulations of dynamic conditions analogous to producing a batch will be factored in. This article will cover phase 1 in the development of such a sampling plan, and future installments will cover phases 2 through 6.