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

Board Notices

Competency Standards in South Africa

Competency Standards for a Specialist Pharmacist who provides Industrial Pharmaceutical services in South Africa

Table 1: Summary of Industrial Pharmacy domains and competencies

Domain 4: Quality Management in Industrial Pharmacy

 

DOMAIN 4: QUALITY MANAGEMENT IN INDUSTRIAL PHARMACY

 

INTRODUCTION

 

Industrial pharmacists must have knowledge of procedures and operations to integrate and apply expertise in establishing, evaluating, maintaining and monitoring quality management systems. The competencies required in the domain of quality management in industrial pharmacy are:

 

4.1 Compliance with quality assurance principles.

 

4.2 Pharmaceutical infrastructure management.

 

DOMAIN 4: QUALITY MANAGEMENT IN INDUSTRIAL PHARMACY

COMPETENCIES

BEHAVIOURAL STATEMENTS
4.1 Compliance with quality assurance principles.
4.1.1 Demonstrate the ability to make decisions relating to complex quality control issues.
4.1.2 Demonstrate the ability to establish, monitor and manage CAPAs.
4.1.3 Develop and maintain quality management systems for manufacturing and distribution of medicines, medical devices and IVDs.
4.1.4 Develop and maintain quality management systems for the control of equipment.