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

Board Notices

Competency Standards in South Africa

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

Table 1: Summary of Clinical Pharmacy Competency Standards

Domain 4: Quality Management in Clinical Pharmacy
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DOMAIN 4: QUALITY MANAGEMENT IN CLINICAL PHARMACY

 

INTRODUCTION

 

The competencies required in this domain implement quality management in clinical pharmacy according to GxP as follows:

 

4.1 Quality assurance.

 

4.2 Pharmaceutical infrastructure management.

 

DOMAIN 4: QUALITY MANAGEMENT IN CLINICAL PHARMACY

COMPETENCIES

BEHAVIOURAL STATEMENTS
4.1 Quality assurance
4.1.1 Demonstrate the ability to develop, implement, and maintain a comprehensive clinical pharmacy system that ensures the quality, safety and efficacy of the pharmaceutical services including the creation and review of:
(a) SOPs;
(b) change control reports;
(c) risk assessments; and
(d) guidance documents.
4.1.2 Raise and investigate deviations and address deviations through Corrective and Preventative Actions (CAPAs).
4.1.3 Establish a quality assurance governance system.
4.2 Pharmaceutical infrastructure management
4.2.1 Design, implement and manage a clinical pharmacy monitoring system.