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.
The purpose of this report is to provide the reader with a background on the complex subject of environmental monitoring and a summary review of the PDA Technical Report No.13 and Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing, CGMP, September 2004. This report discusses the microbiological and particulate control concepts as they relate to the manufacturing of biopharmaceuticals. This paper represents a global view of methods, terminology, and practices of procedures to track, trend, control, and manage an environmental monitoring program. Several of the recommendations are a reflection of the current changing regulatory requirements and standards from various regulatory agencies. (Examples – FDA, MCA, Canada, and EU). In all cases the recommendations represent a guide to meet current Good Manufacturing Practices (cGMP) requirements.Details