Wednesday February 10, 2016
Who is the FDA?
The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, food supplies, cosmetics and radiation emitting products.
What does the FDA inspect?
FDA inspects manufacturers or processors of FDA-regulated products to verify that they comply with the Food, Drug and Cosmetic Act and other relevant guidelines. Among the agenda items for inspection is compliance with FDA 21 CFR Part 11, Electronic Records; Electronic Signatures. In summary, 21 CFR Part 11 requires that:
- Software is tested (validated) for its intended Good Manufacturing Practices (GMP) uses to ensure accuracy, reliability and consistent performance of transactions
- Data is protected so as to enable accurate and ready retrieval throughout the retention period
- Access is limited to authorized individuals
- The Information Technology (IT) infrastructure has been qualified to insure that equipment has been installed using manufacturer technical specifications and procedures
- Procedures are in place that govern the uses of the software’s GMP functionality, i.e., Standard Operating Procedures, Work Instructions, etc.
- Users of the GMP software have been trained on appropriate procedures and that training is evident is company records
- Adequate Change Control is maintained so as to ensure data integrity
Preparation for an FDA inspection includes some of the following practical measures:
- Ensure company quality and compliance goals have the support of senior management
- Review prior FDA inspection observations to confirm they have been resolved
- Perform a Systems Assessment to identify all software in use and confirm there is a plan in place to bring GMP systems into compliance
- Review applicable Standard Operating Procedures and Work Instructions and update as necessary to reflect current practices
- Review training records and conduct training where necessary
- Review Change Control logs to confirm that system changes have been made in a manner that ensures software validation integrity
- Conduct a Periodic Reviews of key processes to ensure practices are in alignment with procedures
- Ensure that audits of critical IT vendors have been conducted or have been scheduled
Arbour Group life sciences industry regulatory experts continually work to ensure that your company is compliant with domestic and international authorities. If you have any questions, comments or concerns, feel free to contact us today!