USP 797 Revision and Impact

Understand the most recent USP 797 revision and the impacts.

The United States Pharmacopeia (USP) is a scientific non-profit organization that sets standards used worldwide for the identity, quality, purity and strength of medicines, food ingredients and dietary supplements. The organization’s mission is to improve global health through public standards and related programs that help ensure that quality, safety, and benefit of medicines and foods. With the advancement of technologies and medicine, new standards are created to ensure the health and wellbeing of the public. The process is as follows:

USP Regulatory Standards Development Process

1. Public Health Need
2. Draft Standard
3. Public Comment Period
4. Review and Approval
5. Publication

Developing USP monographs and official Reference Standards is a collaborative process between USP, manufacturers and expert committees made up of volunteer experts from industry, health care practitioners, academia and government. USP takes a collaborative and rigorous approach to ensure USP Reference Standards reflect the highest quality in the industry, because helping companies comply with quality requirements is one of their chief goals.

This paper also covers:

• Compound Sterile Preparations
  • Beyond Use Dates Requirements
  • Terminal Sterilization
• Personnel Qualification
• Calibrations, Certifications and Qualifications
  • Facility Requirements
  • Certification Requirements of Classified Cleanrooms
• Environmental Quality and Control
• Microbial Air and Surface Risk Assessment
• Microbial Air and Surface Monitoring

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