Pharmaceutical water systems must be appropriately designed, operated, and maintained in order to produce high quality water. USP General Chapter <1231> Water for Pharmaceutical Purposes provides detailed information about nearly every aspect of maintaining, validating, and monitoring a pharmaceutical water system. Validation is the process to demonstrate that the design and operation of a pharmaceutical water system consistently produces water that meets USP requirements. USP General Chapter <1231> provides extensive discussion of the life cycle elements to maintain a validated state of control. This webinar specifically addresses validation and qualification approaches, including design and operation, water sampling purposes and procedures, the “trigger levels” associated with test results, and microbial identification.

Subject area:
Drug Products & APIs

Objectives (If applicable):
• Understand the elements to validate water systems
• Identify the regulatory requirements for validation including FDA and the new EU GMP Guidelines Annex 15
• Develop a sample plan for validation, process control, and quality control
• Identify the ongoing activities needed to maintain a validated state of control

Target Audience (If applicable):
– Water system engineers, owners, and users
– Production managers
– Analytical chemists and microbiologists
– Chemistry and microbiology lab managers
– Validation managers
– QA/QC managers
– Compliance managers
– Regulatory affairs specialists