Management of Pharmaceutical Water in a GMP Environment

Barry Friedman Ph.D.

Course description

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?

This accredited and interactive training will examine a variety of the issues surrounding water in a facility to include the testing of each unit water operation and to what extent. It will cover testing requirements during commissioning and testing on an ongoing basis. The webinar will examine Quality Risk Management (ICH Q9) and discuss how a properly developed Facility Water Validation Plan may lead to a logical, reduced requirement for testing over time.

The training will also explore the time requirement for testing before reduced testing might occur and why some organizations refuse to accept this pathway.

The objective of this webinar is to assist those involved in the development of a process or the manufacturing of a product to explore water, as a raw material (component) in a GMP environment, the requirements for potable water, purified water (PW), water for injection (WFI) and clean steam to assure that they are meeting the current USP, EP, JP and FDA requirements.

Attending the training with your Project Team will be most beneficial to the group.

Upon completion of this course, you will be able to:

• Outline how to develop a water sampling system and its test frequency.
• Define the “Health” of a water system based upon test results.
• Explain the differences between USP, EP and JP water requirements.
• Identify the use of Alert and Action Levels vs. Specifications and what is meant by each.
• Choose when microorganisms should be identified and the preferred methods.
• Show the requirements for in‐house vs. purchased water.
• Examine the determination of various validations that supplement the maintenance of a USP Purified Water or Water for Injection system.
• Determine how to diagnose and control a water system problem.