Setra Blog

Safety is Top Priority. Compliance is Essential. Will you be ready by November 2023?

Revised standards for USP General Chapter <797> for compounded sterile preparation (CSP) have been finalized and have an estimated effective date of Nov 1, 2023. These revisions will also affect USP <800> where hazardous drug (HD) compounding is applicable. Both standards include environmental monitoring and management requirements that were not previously enforced and must be met to achieve accreditation through local and national governing bodies come November 2023. Understanding the conditions and monitoring requirements is critical in ensuring compliance.

For regulated spaces creating electronic records of environmental monitoring and other sensitive data, accuracy and security are of paramount concern. How data is handled in regulated environments like cleanrooms is crucial to both regulatory compliance and data security. Besides the damage a data breach can do to a company’s reputation, a company has a legal obligation to protect user and customer data.