National Custom Compounding - Quality Assurance Plan

Version 4.0 - Revised February 23

© THE TRUSTEE FOR THE Carrara Pharmacy Trust & THE TRUSTEE FOR THE Gooding Drive Pharmacy Trust T/A National Custom Compounding ABN: 17971220310

1.              Introduction. 1

1.1            Purpose of this document. 1

1.2            Responsible Personnel 1

1.3            Quality Assurance Objectives. 2

2.              Standards. 3

2.1            Pharmacy Registration & AS/NZS 85000:2011. 3

2.2            Professional Memberships. 3

2.3            Standards and Certification. 3

3.              Personnel 4

3.1            Quality and Risk Committees. 4

I.                 Quality Management Committee. 4

II.                Risk Management Committee. 4

III.               Verification Management Committee. 4

3.2            Staff Qualifications. 5

3.3            Staff Training. 5

3.4            Infection control 5

4.              Quality Control 7

4.1            Documentation. 7

4.2            Active Pharmaceutical Materials (API). 7

4.3            API Suppliers. 7

5.              Compounding Process. 9

5.1            Internal Process. 9

5.2            Compounding Record Review.. 10

5.3            Verification. 10

5.4            Compounding Facility. 10

5.5            Compounding Equipment. 11

5.6            Independent Third-Party Verification and Analysis. 11

6.              Adverse Events. 13

6.1            Adverse event procedure. 13