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 Verification Program

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

  • Identify your sterile compounding activities.
  • Determine the risk-levels. (Adapted for The United States Pharmacopeial 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.
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Designing a Monitoring Program

Development and verification of the effectiveness of Standard Operating Procedures is the foundation of the CSP Quality Management program. However, it is the ongoing monitoring of the CSP compounding environment, the techniques and daily practices of personnel, and the quality characteristics of the CSPs that provides assurance of quality.

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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
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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.

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