Pharmaceutical Water and the International Regulatory Environment
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Who Should Attend
This session will benefit anyone responsible for designing, managing, sampling, operating, or the validating of compendial water systems. Participants ranging from those with little to no experience with water systems to those with several years of experience will find the session very valuable. It is intended for:-
Engineers
- Quality Assurance and Control
- Facilities Managers
- Utility Managers
- Validation Professionals
- Regulatory Affairs Staff in the Biopharmaceutical Industry
Description
Water is the single largest ingredient used in biopharmaceutical manufacturing and permeates every aspect of biopharmaceutical manufacturing. The uses of water and steam derived from water, constitutes a major operational and quality issue in the industry on a world-wide basis. As such, water is governed by specific requirements for quality and use. This course will review U.S. and all pertinent international standards, as well as options for meeting each.
Module 1:
Overview of U.S. and International regulatory environment
Where water and utility systems fit within the regulatory framework
Regulatory Standards for Water
– Potable Water Sources and the National Safe Drinking Water Act
– Non-compendial Waters (ASTM, CAP, AAMP, Other)
Module 2:
U.S. Pharmacopoeial Waters (USP Purified, Water For Injection, Other)
Alert vs. Action Limits
Current Changes in USP Requirements
Module 3:
International Standards (EP, JP, Canadian and others)
Harmonization Strategies between standards
Evolving changes in water standards
Question & Answer