Compliance

SAFETY, COMPLIANCE & SUSTAINABILITY

At NTP we prioritise safety, quality, the environment, and sustainable business and operating practices.
NTP’s customers rely on us to provide a safe, reliable supply of quality assured radiation-based products, from industrials to active pharmaceutical ingredients (APIs) and final pharmaceutical products. We produce, process and distribute radiation-based products to 50 countries, and are one of the largest and most-trusted global suppliers of medical radioisotopes.

NTP’s premises, products, processes and services are registered, audited and accredited or licensed in strict compliance with South African and international laws and industry standards for nuclear, radiation, and pharmaceutical products. South Africa is a founding member of the International Atomic Energy Agency (IAEA), and ratified the IAEA’s Convention on Nuclear Safety in 1996.

Regulatory environment

The Pelindaba nuclear facility, nuclear products (such as enriched uranium and depleted uranium), and NTP radiation products (isotopes) and services (equipment, transport packaging and transport) are regulated and authorised by the South African National Nuclear Regulator, the Department of Energy, and the Department of Health: Directorate Radiation Control. NTP’s radiopharmaceuticals are also licensed as pharmaceutical products with the South African Medicines Control Council (this will be replaced by a new authority, SAHPRA, under the Medicines and Related Substances Amendment Act, 14 of 2015). NTP is registered with the South African Council for the Non-Proliferation of Weapons of Mass Destruction.

Legal framework

NTP is a subsidiary of the South African Nuclear Energy Corporation (Necsa) and is regulated by statutory South African authorities, according to specific legislation that regulates nuclear facilities, nuclear and radiation products, and pharmaceutical products. These are:

Necsa is responsible for the management of nuclear and radiological waste in South Africa, which is regulated by the National Radioactive Waste Disposal Institute Act 53 of 2008.

Quality and assurance

NTP operates from a licensed nuclear facility at Pelindaba and is authorised as a radioactive material handling facility, with an internationally licensed radioactive material packaging transport fleet.

NTP has received its ISO 9001:2015 from DEKRA Certification GmbH, and has a current Good Manufacturing Practice (cGMP) certificate for the supply of Active Pharmaceutical Ingredients in the EU. The manufacture of radiopharmaceuticals is done so under licences issued by the South African Medicines Control Council.

Our main facility is also audited and approved for manufacture of products destined for the USA by the FDA. NTP Radioisotopes was the world’s first supplier, in December 2010, of FDA-approved all-LEU Mo-99 (produced using both LEU fuel and targets).

Workplace health and safety

NTP supports a workplace culture of safety, responsibility, and accountability.

In addition to complying with stringent regulations and best-practices surrounding nuclear facilities, nuclear and radiation products, and pharmaceutical products, our workplace is governed by the South African Basic Conditions of Employment Act, the Occupational Health and Safety Act, and the Compensation for Occupational Injuries and Diseases Act.

NTP has implemented a long-term Behavioural Based Safety (BBS) programme to improve our safety culture, and, in 2015, conducted a Safety Culture Audit that allowed us to compile a strategic plan listing safety enhancement actions as our business and productivity continue to grow.

Public safety

At NTP we are committed to the safety of our people, our community, and our environment. As a state-owned nuclear facility, we are aware that there is public interest in our site and our operations, and we are proud of our excellent track record in both safety management and incident response and management.

For more information about emergency protocols and procedures at the Necsa Pelindaba site please click here.