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