Where Do I Begin?

USP <797> mandates standards for CSP facilities, personnel training and verification, and quality management processes. The requirements and disciplines of the standard may be unfamiliar to many pharmacists. VALITEQ™ has the products and the expertise to assist you in achieving <797> compliance.

Designing a CSP Facility

Understand the various steps of the designing and building process, including:

• Demographics and Marketing
• Design Qualification
• The Design
• Installation Qualification
• Operational Qualification
• Process Qualification
• Policies and Standard Operating Procedures

View Designing a CSP Facility.

Designing a Verification and Monitoring Progam

Learn the four basic steps to designing a verification and monitoring program:

1. Identify your sterile compounding activities.
2. Determine the risk-level(s). (Adapted for The United States Pharmacepeial Convention, Proposed revisions to Chapter <797> Pharmaceutical Compounding - Sterile Preparation ©2006.)
3. Identify the most complex processes and equipment encountered by each group of compounding personnel.
4. Monitor key components of your CSP System.

View Designing a Verification and Monitoring Program.

Designing a Quality Management System

Understand the dilemma of CSP Quality Management, learn how to apply the Craftsmanship approach to you quality management system, and control contamination at your facility.

View Designing a Quality Management System.