Pharmacy Act, 1974 (Act No. 53 of 1974)

Board Notices

Competency Standards in South Africa

Competency Standards for a Specialist Pharmacist who provides Radiopharmaceutical Services in South Africa

Table 1: Summary of Radiopharmacy Competency Standards

Domain 4: Quality Management in Radiopharmacy
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DOMAIN 4: QUALITY MANAGEMENT IN RADIOPHARMACY

 

INTRODUCTION

 

Radiopharmaceuticals must be handled with care to ensure their safety and efficacy. The competencies required in this domain which relates to the implementation of quality management in radiopharmacy according to the applicable guidelines, are as follows:

 

4.1 Quality assurance.

 

4.2 Pharmaceutical infrastructure management.

 

DOMAIN 4: QUALITY MANAGEMENT IN RADIOPHARMACY

COMPETENCIES

BEHAVIOURAL STATEMENTS
4.1 Quality assurance
4.1.1 Develop, implement, and maintain a comprehensive Radiopharmaceutical Quality Management System (QMS) to ensure the quality, safety and efficacy of the radiopharmaceuticals including the drafting and review of—
(a) SOPs;
(b) change control reports;
(c) risk assessments, and
(d) guidance documents.
4.1.2Identify and investigate deviations and create CAPAs.
4.1.3 Demonstrate and understand analytical methods and instruments used in the quality control of radiopharmaceuticals.
4.1.4 Develop, implement, and maintain validation processes.
4.2 Pharmaceutical infrastructure management
4.2.1 Design, implement and manage a radiopharmacy environmental monitoring system.
4.2.2 Implement a programme for the maintenance of equipment used in the manufacturing and compounding of radiopharmaceuticals.
4.2.3 Implement a programme for the maintenance of equipment used in the quality control of radiopharmaceuticals.
4.2.4 Implement a programme for the maintenance of the radiopharmacy facility including the air handling unit.