Friday September 30, 2022
Why is Supplier Management necessary for the Life Sciences?
When ensuring adequate supplier controls, organizations in the life sciences aim to manage supplier risk, compliance, and selection of suppliers. Pharmaceutical and medical device suppliers provide products to life science manufacturers so they can make their final product. Regulatory agencies hold the life sciences manufacturer responsible for documenting their supplier’s compliance. Pharmaceutical and medical device manufacturers must provide adequate documentation demonstrating that their suppliers meet FDA guidelines.
Supplier Management Guidance
The former Global Harmonization Task Force was created as a concise guide for regulatory systems and can be implemented for the process of supplier selection and control. The International Medical Device Regulators Forum (IMDRF) is the current group of regulators addressing regulatory requirements and recommendations for best practices.
Supplier Planning & Evaluation
The recommended first step in selecting a compliant supplier is planning. It is essential to describe and document the specifications of the manufactured product. Planning steps would include (1) establishing documented product requirements and quality management system requirements, (2) assembling names and contact information of suppliers, and (3) identifying and documenting possible risks and potential controls. The plan also acts as guidance when finalizing and monitoring supplier compliance. The selection of potential suppliers involves investigating the risk of vendor capability, product quality, safety, and reliability. FDA approval is important and necessary; evaluating suppliers to help meet compliance goals is essential in running a compliant pharmaceutical or medical device company.
Supplier Finalization & Monitoring
Setting supplier controls and responsibilities is a guideline for supplier selection, allowing for the finalization of a trusted network of suppliers. Delivery, measurement, and monitoring is the final step in supplier selection. After product delivery, life science companies must assess acceptance criteria by testing, measuring, and analyzing their manufactured product. Compliance in the life sciences requires ongoing maintenance. Pharmaceutical and medical device companies must commit to continuous monitoring of supplier processes.
Supplier Feedback & Communication
Once a network of suppliers has been identified and monitoring has been established, communication is key between the manufacturer and supplier. As the life sciences manufacturer adheres to Good Manufacturing Practices and meets compliance requirements, it is critical to maintaining regular correspondence with all suppliers. Communications with positive and negative supplier results should be recorded and documented. Once again, documentation is key for life sciences adhering to regulatory agencies.
The Arbour Advantage
Committing to supplier management and controls is a further dedication to meeting FDA compliance and other regulatory agencies. Pharmaceuticals, medical devices, biotechnology, and diagnostics look to Arbour Group for software testing and meeting compliance requirements. Contact us to discuss how we can further assist your supply chain compliance.