Pharmaceutical companies are embracing the challenge of sustainability and responsible business, with heavy focus on how the industry can better engage, monitor, and improve their suppliers and contract manufacturers. From quality excursions can lead to patient safety risks and economic losses for companies, to environmental waste discharge from manufacturing operations that can damage the surround environment, the external stakeholder demand for robust supply chain risk management is increasing. Our audit services, provided by our experienced experts, will help strengthen quality and environmental, health & safety control systems, reduce risks, and improve patient safety.
▪️Compliance audit, supplier audit services based on various GMP and GDP standards
Our GMP/GDP compliance audits and supplier audit services provide an objective perspective to identify potential risks and areas for improvement, strengthen your quality control system, and provide solutions to minimize risks.
▪️Our original Waste Management vendor audit services – EHS Waste disposal and Security Waste Destruction
To ensure the security of the waste management process, we provide verification and evaluation of the following items:
- Detailed reviews of waste and recycling facilities to ensure safe and environmentally responsible disposal of waste from pharmaceutical manufacturing sites
- Review of expected vs. actuals waste disposal volumes and categories of waste to ensure fully traceability of waste to align with EHS and sustainability objectives such as Zero Waste to Landfill.
- Verify the security measures implemented at the waste vendor's site.
- Verify the security of storage and transportation from the manufacturing or packaging facility to the waste vendor's site.
- Ensure that each destruction event is witnessed, properly managed to prevent any risks of substandard medicines or branded packaging entering markets illegally.
▪️Environmental, Health & Safety, Labour / Human Rights audit in Japan and overseas（PSCI）
PSCI (Pharmaceutical Supply Chain Initiative) audit program is an audit service that evaluates governance, management systems, corporate ethics, human rights, environment, and occupational safety and health in the pharmaceutical industry supply chain. PSCI was established to establish ethical, social and environmental standards in the pharmaceutical industry and to assess supplier compliance with these standards. BSI is one of the originally qualified PSCI audit firms, and support the development of the PSCI requirements and the audit approach with the program itself.
