Microbiology of Water in a GMP Environment; USP, EP, JP and FDA Requirements
: 16 Oct 2019
Sector: Pharmaceutical, Water
Type: Training, Webinar, Seminar
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 training 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 in a GMP environment, the requirements for potable water, purified water, water for injection and steam to assure that they are meeting the current USP, EP, JP and FDA requirements.
- Learn how to set up a water sampling system and its test frequency.
- Determining the “Health” of a water system based upon test results.
- What are the differences between USP, EP and JP water requirements.
- The use of Alert and Action Levels vs. Specifications and what is meant by each.
- When should microorganisms be identified and the preferred methods.
- Understanding the requirements for in-house vs. purchased water.
- Determination of various validations that supplement the maintenance of a USP Purified Water or Water for Injection system.
- How to diagnose and control a water system problem.