Primary tabs

Short Learning Programme
on
Quality Assurance in the Pharmaceutical Manufacturing Industry
To provide pharmacists and other personnel working in the pharmaceutical manufacturing industry with the knowledge, skills and understanding required to ensure high standards of Quality Assurance in the development, manufacturing and control of medicinal products.

Purpose of the course:

Successful completion of this short learning programme should provide participants with the knowledge and understanding to implement principles and processes that will ensure compliance with current quality standards

Admission requirements:

Admission requirements: 
None
Learning assumed to be in place: 
BPharm degree (or equivalent) OR Grade 12 certificate with a basic understanding of pharmaceutical manufacturing principles and quality assurance in a pharmaceutical environment.

Course outcomes and assessment criteria :

Course outcomes and the associated assessment criteria: 

Study Unit

Outcomes

Assessment Criteria
  After completion of this course, participants will: Participant will be assessed on the following criteria:
The participant will have the detailed knowledge, understanding and be able to apply Quality Assurance concepts in the pharmaceutical industry.

Describe the various concepts of Quality Assurance and apply these concepts and principles pertaining to:

  • Documentation
  • Organisation and Personnel
  • Premises and Equipment
  • Complaints and Product Recalls
  • Change Control
  • Product Quality Review (PQR)
  • Self-Inspections

The participant will have the detailed knowledge, understanding and application of Good Manufacturing Practices (GMP).

Demonstrate a detailed understanding and application of GMP principles pertaining to

- the storage and release of materials;

- qualification and validation of utilities,

- equipment and processes; and

- production of pharmaceutical products.
The participant will have an detailed understanding and knowledge of the requirements for sampling, analytical testing and stability testing Demonstrate the ability to select, evaluate and effectively implement the processes used in sampling and testing and be able to identity and rectify non-conformities in these fields
The participant will have an detailed understanding and skills to apply the basic principles regarding quality risk management (QRM).

Demonstrate an understanding of the basic principles and the concept of quality risk management (QRM). 

Ability and skills to identify quality problems in the pharmaceutical manufacturing industry and through using the appropriate QRM tool the student will be able to analyse and assess the problem and will be able to propose and implement the necessary corrective and preventative actions

 

Assessment: 
Assessment will be performed by means of compulsory work assignments.
Method of assessment: 
Participants will be assessed by means of compulsory work assignments.

Additional information

F25 100 1
Mode of delivery: 
Mixed
Target group: 
Pharmacists and other personnel working in the pharmaceutical manufacturing industry
Contact us
Name: 
Mr Andy de Koker
E-mail: 
andy.dekoker@nwu.ac.za
Telephone number: 
(018) 299 2260