Quality Management Program for Environmental Monitoring – Part 1

Frank S. Kohn, PhD, SM(NRM),ASCP,CCM
FSK Associates, Inc.
Manson, Iowa 50563 USA
ABSTRACT
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.
PART I
INTRODUCTION
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.

Quality Management Program for Environmental Monitoring – Part 2

Frank S. Kohn, PhD, SM(NRM),ASCP,CCM
FSK Associates, Inc.
Manson, Iowa 50563 USA
ABSTRACT
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.

Novatek’s NOVA-EM

The Environmental Monitoring Data Management & Trending System Software – The Industry Standard It seems like just yesterday, when the Pharmaceutical Microbiology Forum Newsletter – March 2004, Vol. 11 (1) was published. One of the hot topics at the time was Environmental Monitoring (EM) and the question of the day was: How many people are…

Novatek International Travels to the Philippines

Novatek International organized an open forum with various Philippine Pharmaceutical Associations. Novatek’s objectives during this event were: To provide an update on global trends and guidelines (and present the Novatek solutions suite and examples of its capacity building activities with the pharmaceutical industry in other regions). To identify priority capacity building needs of the Philippine…

PDA New England Chapter presents, “Risk Based Environmental Monitoring Conference” March 2015

Stay up to date with the latest concepts on Risk-Based Environmental Monitoring with Novatek at your local 2015 PDA Chapter events: Topic Overview Non-viable air and viable air and surface monitoring of controlled environments is not a new concept and has been a regulatory requirement for many years. In the past, many companies selected Environmental…

READY, SET GO 2016!

A very happy 2016 to all of our industry followers, clients, colleagues and friends! Novatek is entering into their 20th year serving the global pharmaceutical and biotech industries and we could not be where we are today without the gratitude of our valued clients, respected partners, and appreciated staff. 2015 was a year of continued…