The regulatory landscape of good manufacturing practices (GMP) has continued to evolve as advanced products are brought to market and gaps in existing regulation are identified. Interactions between statutes, regulations, and guidance and the application of those by inspectors while at a manufacturing site can create ambiguities that must be managed with a strong regulatory strategy. Sidley has led and assisted with analysis and strategic decision-making for various manufacturers of drugs, biologics, devices, and combination products in multiple market settings — whether for a client’s own manufacturing sites or in contract manufacturing or private label scenarios.
Members of our dedicated GMP team include former U.S. Food and Drug Administration (FDA) lawyers, government prosecutors, and industry subject-matter professionals. Our extensive capabilities, combined with a history of FDA engagement, allow companies to take proactive steps to mitigate potential enforcement activity and achieve swift resolution of pending matters.
We represent numerous clients with complicated regulatory histories related to the manufacture of complex products. We work closely with manufacturing sites to develop action plans with effective corrective and preventative measures in response to a variety of product-related investigations. In addition, our lawyers have significant experience conducting whistleblower and internal compliance investigations related to GMP violations. Our engagement strategies with the FDA and other regulatory agencies facilitate a positive path forward. In the event of further enforcement action, government investigations, or litigation, our team is capable of continuing representation until the resolution of any action.
Our value-added services include:
- Analyzing manufacturing sites and corporate functions for GMP and quality system regulation (QSR) compliance, including aseptic processing, combination products, sterile and other high-risk devices, post-marketing surveillance, and complaint handling
- Performing gap analyses and developing GMP and QSR work plans
- Training personnel from the site level to the executive suite on GMP and QSR enforcement activity and best practices
- Assisting with inspection readiness activities, including the development of storyboards for complex issues
- Advising on recalls, supplier management, and safety reporting, with a focus on compliance with medical device reporting (MDR) and adverse drug event (ADE) requirements
- Conducting discrepancy, non-conformance, deviation, corrective and preventive action (CAPA), and product impact investigations with detailed root cause analysis
- Engaging with the FDA and other agencies on behalf of a firm for previous or upcoming inspections, as well as ongoing compliance commitments
- Supporting responses to FDA 483 inspectional observations, Warning Letters, and other government inquiries
- Performing data integrity and documentation practices investigations
- Advising companies on identifying third-party expert consultants and compliance action plans
Our network of offices and international reach allow us to respond promptly to government inspections and enforcement actions and to coordinate company actions plans and communications with regulatory authorities and the press worldwide. We have worked with manufacturing sites in a number of countries: