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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 3: Supply of Medicines, Medical Devices and In-Vitro Diagnostics

 

DOMAIN 3: SUPPLY OF MEDICINES, MEDICAL DEVICES AND IN-VITRO DIAGNOSTICS

 

INTRODUCTION

 

The industrial pharmacist plays an important role in the supply and distribution of medicines medical devices and IVDs. The competencies required in this domain are as follows—

 

3.1 Manufacture and control of medicines, medical devices and IVDs, and inventory control of APIs.

 

3.2 Supply chain management.

 

DOMAIN 3: SUPPLY OF MEDICINES AND MEDICAL DEVICES

COMPETENCIES

BEHAVIOURAL STATEMENTS
3.1 Manufacture and control of medicines, medical devices and IVDs, and inventory control of APIs.
3.1.1 Manage and control the inventory of APIs.
3.1.2 Maintain the storage conditions for APIs and other excipients.
3.1.3 Verify the quality of finished products before release.
3.1.4 Import and export medicines, medical devices and IVD.
3.1.5 Ensure that storage conditions for API and other excipients are maintained according to the manufacturer’s specification and GMP.
3.1.6 Ensure that the finished products and medical devices meet quality, safety and environmental control requirements.
3.1.7 Manage the storage and transportation of finished products in accordance with GxP.
3.1.8 Perform pharmacokinetic and pharmacodynamic dosing alterations.
3.2 Supply chain management
3.2.1 Develop, maintain and monitor health systems for the import and export of medicines, medical devices and IVD.
3.2.2 Design the warehouse area to ensure compliance with Good Distribution and Warehousing practices.