How Does IC Biomedical Support cGMP for Biomedical Operations?
Strong, organized compliance procedures help biopharmaceutical operations achieve and maintain Current Good Manufacturing Practices (cGMP) regulations. cGMP is a set of quality standards that ensure the safety and quality of drugs and other medical products that are enforced by the Food and Drug Administration (FDA) in the US and other regulatory agencies around the world.
IC Biomedical has introduced the Revolution Series, an innovative line of cryogenic freezers with features designed for operational compliance in highly regulated environments:
- cGMP for Biopharmaceutical production
- Clinical trials
- Regulated storage of transplant cells or tissue
Revolution Series for Secure Sample Access, User Management Tracking and Audits
- A built-in touchscreen User Management System allows for creation of unlimited user profiles with individual permissions. Users can access samples through the locking lid by manually entering a password or with an RFID badge. By using Revolution’s optional motorized sample tray, users can be limited to a specific sample section(s), which provides greater overall security in addition to easily locating specific samples.
- Full audit trail function records all actions undertaken by a signed-in individual, including time and date stamps. Revolution allows users to easily conduct regular audits to assess compliance with cGMP requirements and identify any areas of improvement.
- Each control unit can operate as a web server, allowing for remote access to all operational functions. Onboard IoT functionality connects to available cloud or an intranet server for full data collection and storage with external access and monitoring.
cGMP compliance facilitation can be provided by internal staff, external consultant, or both. The best approach for an organization is normally based on its size, complexity and resources.
Here are some specific tips for facilitating cGMP compliance:
- Build a strong compliance foundation. Make sure all levels of employees understand the importance of cGMP compliance and their individual role in supporting it.
- Be proactive. Don’t wait for the FDA to come knocking. Identify and address any potential compliance issues before they become major problems.
- Be systematic. Use a measured, consistent approach to cGMP compliance, such as implementing a Quality Management System (QMS). This will help ensure that all aspects of the manufacturing process are covered.
- Be relentless. cGMP compliance is a never-ending process. It’s important to regularly audit and review your systems and procedures to ensure that they are effective.
For more information on the new Revolution Series, click here.