Microbiology of Water in a GMP Environment

Introduction

Knowledge of the microbiology of water in a GMP environment is critical to the health of any water system being used to produce a pharmaceutical or biotechnology product.  Even companies manufacturing tablets need to be aware of the quality of the water that may be contacting their process or product.  The well being of a facility revolves around the health of each water system within that facility.  How often have we learned of a facility being closed for weeks at a time because of a water system that has exceeded its microbiological specifications?

The objective of this live and interactive BenAstrum web training course is to assist those involved in the development of a process or the manufacturing of a product in assuring that they are meeting the current USP, EP, JP and FDA requirements.

Discussion Points:

• Identifying the requirements established for purified water, water for injection and clean steam
• Gaining the understanding to set up a water sampling system and its test frequency
• Understand the “Health” of a water system based upon test results
• Understand the impact of water quality on APIs and final products
• Troubleshooting the water system
• Data management
• Determining when to decrease testing

Learning Benefits:

• Understanding the requirements for in-house vs. purchased water
• The differences between USP, EP and JP water requirements
• The use of Alert and Action Levels vs. Specifications
• When should microorganisms be identified and the preferred methods
• Determination of various validations that supplement the maintenance of a USP Purified Water or Water for Injection system
• How to diagnose a water system problem

Who Can Benefit:

Those who will benefit from this seminar include Quality Assurance, Quality Control, Validation professionals, Manufacturing and Facilities Management.  Personnel involved in the technology transfer of early stage products will also benefit by assuring that they are using water that is not interfering with their process or potential clinical trial material.

Please click here for the course agenda