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 2: Design and Maintenance of Facilities

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DOMAIN 2: DESIGN AND MAINTENANCE OF FACILITIES

 

INTRODUCTION

 

Industrial pharmacists must have knowledge of the procedures and operations to design and maintain pharmaceutical manufacturing and distribution facilities. The competencies required in the domain for design and maintenance of facilities in industrial pharmacy are:

 

2.1 Design of manufacturing facilities.

 

2.2 Design of warehousing and distribution facilities.

 

2.3 Pharmaceutical infrastructure management.

 

DOMAIN 2: DESIGN AND MAINTENANCE OF FACILITIES

COMPETENCIES

BEHAVIOURAL STATEMENTS

2.1 Design of manufacturing facilities
2.1.1 Ensure that the design and maintenance of the manufacturing facility comply with regulatory requirements.
2.1.2 Ensure that the dossier storage facilities comply with regulatory requirements.
2.1.3 Monitor compliance with the health and safety policies.
2.2 Design of warehousing and distribution facilities
2.2.1 Ensure that the design and maintenance of the warehousing and distribution facility comply with regulatory requirements.
2.2.2 Monitor compliance with the health and safety policies.
2.2.3 Ensure compliance with the Occupational Health and Safety Act and all other applicable legislations and guidelines.
2.3 Pharmaceutical infrastructure management.
2.3.1 Develop and maintain quality management systems for the design and maintenance of pharmaceutical manufacturing facilities.
2.3.2 Develop and maintain quality management systems for the design and maintenance of pharmaceutical wholesaling facilities.
2.3.3 Develop and monitor compliance with health and safety policies.