Quality control of medicines

Quality control of medicines

Medicines play a vital role in health care. Safe, efficient, quality medicines help control and prevent common diseases and alleviate suffering. Substandard medicines, on the other hand, have the opposite effect. That’s why it’s so important to have medicine quality control measures in place.


 What is quality control?


Quality control is the use of standards and procedures to ensure:


    • The proper identification and quality level of a product


    • That the product satisfies the stated or implied role.


Why quality control?


People want to know that the medicines they use are of good quality and proven efficacy and safety, and that they are continuously available at a reasonable cost. For this purpose, there is a national policy for the provision of safe and cost-effective medicines in most countries.


Medicines Control Council (MCC) of South Africa


In South Africa, the regulation and control of medicines fall under the protection of the Medicines Control Council (MCC), a statutory body established in accordance with the Medicines and Related Substances Act. The Council must ensure that the medicines available to the South African public are safe, effective and of high quality, and that their availability is in the public interest. Applications for clinical trials and for registration of medicines and medical devices are therefore reviewed by an MCC expert committee. This committee checks the scientific, medical and ethical issues of the applications.


In ensuring the quality of medicine, three things are looked at, namely the:


    • Product itself


    • Manufacturing of the product


    • Handling and distribution of the product.


Medicines from licensed suppliers are regularly identified and checked with the help of standard operating procedures as well as audits of manufacturers, distributors and providers.


NWU centre for quality assurance of medicine


In addition to the MCC, the World Health Organisation Collaborating Centre for the Quality Assurance of Medicines (Cenqam) of the North-West University has recently been appointed by Nepad (New Partnership for Africa’s Development) as a regional centre of excellence. This centre is one of a kind in South Africa. Its director, Dr Marius Brits, says that this centre plays a vital role in the development of the regulatory capacity in Africa.


To some extent, however, medicine quality is a shared responsibility among all involved, ranging from manufacturers to users. Effective communication among all stakeholders, especially in terms of providing feedback regarding complaints about medicine quality, is therefore essential.




NWU centre one of its kind in SA. Retrieved from: http://pressoffice.mg.co.za/universityofnorthwest/PressRelease.php?StoryID=252938


Quality control. Retrieved from: http://medical-dictionary.thefreedictionary.com/quality+control,


The Medicines Control Council. Retrieved from: http://www.sanctr.gov.za/YourRights/TheMedicinesControlCouncil/tabid/176/Default.aspX


Revised by M van Os