Quality Policy

NBI strives to meet the needs of patients and improve their quality of life by providing protein therapies and services within the South and Sub-Saharan African region and diagnostic products globally.

NBI focuses on meeting the requirements of those in need of its products, and the healthcare provider. In doing so, NBI endeavours to be the leading African manufacturer and supplier of quality therapeutic proteins and diagnostic products that improves the lives of patients.
NBI operates in a highly regulated pharmaceutical environment complying with, inter alia, the terms of the Medicines & Related Substances Control Act  (Act 101 of 1965), Pharmacy Act (Act 53 of 1974), MCC Guidelines and international quality standards.

NBI has a firm commitment towards quality, therefore NBI's Quality Management System (QMS) is aimed at assuring that the desired product quality is routinely met, suitable process performance is achieved, the set controls are appropriate, and continual improvement opportunities are identified and evaluated. The QMS at NBI applies to all areas of the business and has been implemented to ensure compliance to cGMP requirements as well as utilizing many of the elements of ISO systems.

The following are key to the Quality Mission:

  • Quality principles will be integrated into strategic planning to ensure that the commitments to patients, regulators and other stakeholders are fulfilled.
  • Each staff member, as well as NBI as a whole, is responsible to strive for excellence in the manufacture, sale and distribution of biological products with which NBI is directly concerned.
  • NBI will:

    -   Ensure that all its systems meet or exceed the requirements for cGMP and good laboratory techniques.
    -   Strive to ensure that it has suitably qualified and experienced staff to meet its commitments.
    -   Respond positively and appropriately to the changing needs of its stakeholders and their concerns.
    -   Engage in continual improvement that ensures quality, safe and effective products, reliable and accurate operations and reduced production losses through routine surveillance of the system.   (Abridged)