The Facts About Combination Product Regulation and Risk Management
Combination products offer novel or improved treatment options, but can present significant regulatory and risk management challenges. Because these products incorporate two or more regulated components, the ability to achieve regulatory compliance and managing compliance risks can be complex and time-consuming.
Fortunately, there are steps you can take to make compliance and risk management easier.
Understanding Your Compliance Obligations
The first step in achieving regulatory compliance is to determine the correct regulatory pathway for your combination product. Determining the primary mode of action (PMOA) of your combination product is crucial to identifying the lead agency center, and, therefore, the correct regulatory pathway for your product.
If you are unable to determine the PMOA, filing a request for designation should help you identify the correct pathway.
Managing Your Compliance Risks
Once you have identified and understood your compliance obligations, you can take steps to manage your compliance risks. Risk management is key to achieving compliance and minimizing the likelihood and severity of product recalls and other adverse events.
Effective risk management involves paying particular attention to managing risks across your supply chain. Follow these tips to reduce your risk for non-compliance.
Develop Tailored Quality Agreements
For best results, ensure your quality agreements detail your individual preferences and regulatory requirements.
Be sure to implement an integrated supply chain to help you coordinate activities across partners and schedule production so that you can deliver your combination product on time.
Audit Your Suppliers
Perform an audit of your suppliers’ manufacturing facilities or, when available, consider accepting third-party safety and quality certifications.
Improve Supply Chain Reliability
Choose suppliers that follow Current Good Manufacturing Practices. For best results, ensure that your suppliers establish and maintain adequate quality management processes.
Establish Proper Change Management Procedures
Be sure that your suppliers have procedures in place for change management and notification of change. You should also consider implementing additional risk management procedures, including key performance indicators and corrective and preventive action plans.
Regulatory compliance and risk management are crucial to the success of your combination product. At Quality Solutions Now, we can help you identify and meet your compliance obligations for a faster time to market. For more information on our regulatory and risk management solutions, contact our experienced consultants today.