19 September 2024 – A GSK Plc site has become the first in the UK to achieve certification to an Antibiotic Manufacturing international standard, demonstrating the company’s commitment to addressing antimicrobial resistance (AMR) through the responsible manufacturing of antibiotics and addressing environmental waste concerns.
BSI, the business improvement and standards company, announced that GSK’s Worthing site, which manufactures, packages and distributes antibiotic medicine to over 90 markets worldwide, has seven antibiotic products that have achieved BSI Kitemark Certification for Minimized Risk of Antimicrobial Resistance. This demonstrates GSK is taking the necessary steps to ensure antibiotics are manufactured responsibly by appropriately controlling waste streams, helping to minimize the risk of aquatic toxicity in the environment and the spread of AMR.
The AMR certification involved an initial evaluation of the manufacturing processes of seven antibiotic products produced at the GSK Worthing site against the standard’s requirements and will be maintained by annual surveillance to verify ongoing maintenance of the appropriate controls. Like all BSI Kitemark certification programmes, it is rigorous and challenging for organizations to achieve.
The Antibiotic Manufacturing standard was developed by BSI and the AMR Industry Alliance in 2022 to outline best practice controls and methods for the responsible manufacturing of antibiotics in the global supply chain. The BSI AMR Kitemark certification provides independent assurance of the steps being taken to comply to the standard, ensuring that antibiotic waste streams containing active pharmaceutical ingredient (API) and drug products are appropriately controlled during manufacturing.
Courtney Soulsby, BSI Global Director, Healthcare Sustainability, said: “GSK has taken a critical step forward to address the growing threat from AMR and reduce antibiotic discharge from the manufacturing process into the environment. GSK is leading the way in the fight against antimicrobial resistance, including efforts towards responsible antibiotic manufacturing and our hope is that other organizations follow, so that we can collaborate and accelerate progress towards a more sustainable world.”
Regis Simard, President, Global Supply Chain, GSK, said: “GSK is committed to addressing the urgent public health threat of antimicrobial resistance by developing new vaccines and medicines against infectious disease, improving access to antibiotics, and ensuring we manufacture antibiotics responsibly. It’s fantastic to see GSK Worthing become the first site in the UK to achieve this internationally recognised standard. Our aim is for all our global antibiotics manufacturing sites to be certified by the end of 2026, demonstrating the action GSK is taking to address AMR and support the health of people and the planet.”
AMR is a major global health threat and is particularly prevalent in low resource settings, deepening existing health inequities and risking the efficacy of current medicines to fight diseases. AMR is estimated to have caused more than 1.2 million deaths in 2019, more than either HIV or malaria.
AMR occurs when bacteria, viruses, fungi and parasites change over time and no longer respond to medicines. Drivers of AMR include the overuse and misuse of antibiotics in human and animal health, as well as in agriculture, the insufficient use of preventive measures, such as vaccination and infection prevention and control practices, and the presence of antimicrobials in the environment. As a result of drug resistance, antibiotics and other antimicrobial medicines become ineffective, and infections become difficult or impossible to treat. Pharmaceutical manufacturers face the challenge of controlling waste to maintain safe concentrations of antibiotic discharge into the environment.
