Installation Instructions

Pharmacy Solution Set Matrix
Requirements based on:
• USP 795: Pharmaceutical Compounding – Nonsterile Preparations (Proposed Revision: March 2018) A6V11517837
• USP 797: Pharmaceutical Compounding – Sterile Preparations (Proposed Revision: July 2018) Rev 1 September 2018
• USP 800: Hazardous Drugs – Handling in Healthcare Settings (Proposed Revision: February 2016) Page 13 of 17
USP-NF Chapter 800 Requirement
Evaluation
Engineered Services & Solutions
Building System
Information Management
Service Solutions
Standard Operating Procedures
The compounding facility must establish and
follow written standard operating procedures
(SOPs) designed to ensure the quality of the
CSPs. The SOPs must cover:
 Calibration
 Environmental monitoring
Documentation Standards
All records must be retained for at least three
years or as required by the state laws and
regulations, whichever is longer.
 Desigo CC provides a means of
archiving, managing, processing, and
retrieving business-critical data for a
range of information management and
reporting needs including analysis,
compliance, and management
reporting.
 Automatic linking of SOPs
 Training
 Reporting
 SOP development