FDA Consent Decree

If a company has repeatedly violated or significantly deviated from current good manufacturing practices (cGMPs), the FDA may make a legal agreement with the company to force it to make specific changes to the manufacturing process of a consumable item (such as pharmaceuticals or biotech devices).  A consent decree, which is enforced by the federal courts, is a very strong regulatory action and mandates that a company initiate change. 

Impact

A consent decree may require that a company stop marketing a product or could also halt manufacturing until the sited defects are corrected.  The consent decree will outline steps that a company has to take in order to return to full, independent production.  Consent decrees often include fines, reimbursements to the government for inspection costs, due dates for specific actions, and penalties for noncompliance.  Consent decrees usually are permanent, but at times specified in the agreement when the firm has achieved compliance, it can petition the court to remove the decree. 

Challenge

Manufacturing pharmaceuticals or other consumable products requires complex processes and stringent safety and security methods. Keeping track of documentation, ensuring changes to a manufacturing process are done safely, and standardizing risk assessment and management methodologies can be challenging for large organizations. Under the microscope of a consent decree places added pressure on operations.  The manufacture of a single drug requires numerous risk assessments and safety measures, as well as the design of machinery and processes specific to that product and the hundreds of compounds that it comprises. Lack of a consistent, standard format for quality risk identification, analysis and mitigation can lead to undesirable events, unsafe products and processes and actions from regulatory bodies, like consent decrees.  A consent decree is often a signal that a company needs to either improve its Quality Risk Management program or improve the transparency of its risk management.

The Dyadem Solution

The Stature enterprise risk management solution can assist with all aspects of a quality risk management, ensuring that risk is properly identified, analyzed, mitigated and monitored. Stature can provide your organization with a common quality framework, ensuring that everyone is speaking the same quality language, helping develop a unified quality and risk culture and ensuring that you are always aware of the risks that could impact patient safety and your business. The Stature Risk Management, Management of Change and Incident Management modules support multiple workflows that can be configured to any corporate standard and provide a global risk register of all risks across the organization. By allowing you to view risk holistically from the start, Stature can help ensure potential risk is addressed efficiently and effectively, leading to good manufacturing practices for your organization.