Course Objectives - SPPC Program Structure
- Implementing cleanroom principles and practices that comply with USP Chapter <797> and <800> requirements and other industry best practices
- Understand the Engineering controls and airflow science
- Ensures competency of all personnel involved in sterile compounding, validation, staff training and documentation.
- Understand the Principles associated with workflow, cleaning, environmental sampling, validation, and documentation.
Sterile Compounding Certificate Program Structure
Reading USP 797 and USP 800
1- Self-study module Available online (2 weeks)
Successful completion the post-test of self -study module with 80% passing rate (3 attempts permitted)
2- Practical module On-site (Discussion and Practice) (2 weeks)
- Media fill test (result will require 14 days)
- Fingertip sampling
- Successful hands-on demonstration under supervision of expert pharmacist (3 attempts permitted)
Sterile Product Preparation Certification (SPPC)