Frank S. Kohn, PhD, SM(NRM),ASCP,CCM
FSK Associates, Inc.
Manson, Iowa 50563 USA
This two part technical report will put forward series of recommendation for a quality management program for Environmental Monitoring and Control. This included an evaluation of industry practices, regulatory requirements, and current methods utilized by Biopharmaceutical plant sites. The result of this effort has developed into a listing of several recommendations for potential implementation at plant sites. These recommendations include environmental monitoring controls at all stages of product development and supply chain production.
The management and control of an acceptable environmental program is extensive and comprehensive. This is the reason for a brief over view of the subject to assist in understanding the recommendations provided.Details