The OBP Quality Management System is the custodian of all aspects of ensuring quality products at OBP, it forms the interaction between the processes within the organization. The OBP’s quality management system is based on the requirements of ISO 9001:2015 as well as Current Good Manufacturing Practice (cGMP).

The quality management system is based on preventing non-conformity during product development, manufacturing and distribution and use of the manufactured products by establishing and maintaining an environment which encourages all employees to comply with the established standards and to pursue continuous improvement in quality and productivity throughout the company and its suppliers.

As a South African based world-class pharmaceutical company, OBP acknowledges its responsibilities to internal employees, employees of providers of goods and services (suppliers), customers, members of the community and all other stakeholders with respect to Safety, Health, Environment and Quality management.

Furthermore, OBP is committed to living its Quality and Health and Safety Values in all its daily activities and operations.

The company suppliers and customers require a high level of systems confidence which is why OBP pays special attention to ensure their compliance to ISO 9001:2015 Quality Management System which later will is imperitigve in achieving GMP compliance.

Quality System Scope

Scope

Onderstepoort Biological Products Ltd has two scopes of operation:

  1. OBP researches, develops and produces viral and bacterial vaccines. The company receives manufactures, tests, packs, stores and dispatch Viral and Bacterial vaccines,intermediates, Antigen, Sera and Antitoxins.
  2. OBP receives raw material for manufacturing, testing, packaging storage and dispatch of media.

This Quality Policy Manual outlines and documents the company Quality management system (QMS) in accordance with the requirements of ISO 9001:2015 Standard as applied to the Design, Manufacture and Distribution of veterinary viral and bacterial vaccines.