The number of warning letters sent by the U.S. Food and Drug Administration (FDA) jumped nearly 80 percent from 2007 to 2013, with life science companies contributing the most to this number.
Staying ahead of FDA compliance issues can be a difficult task, especially when you consider all the moving parts involved in the pharmaceutical and medical device manufacturing process.
In this post, we’ll take a look at the top FDA compliance pitfalls, with proven strategies on how you can avoid them.
1. Not Documenting Procedures
Not having written procedures (or failing to follow the procedures you do have) is one of the most common citations pharmaceutical and medical device companies received in 2015. An effective Document Control system solves this problem, helping you centralize and standardize all the processes related to production.
Of course, many companies already have such as system and are simply not leveraging it effectively. Key steps here include:
- Ensuring any document changes trigger updates to employee training requirements.
- Regularly reviewing and updating documents.
- Involving key individuals in creating documents to ensure they aren’t out of step with the reality of how people actually work.
2. Inadequate Complaint Handling Processes
Almost 300 medical device companies received this citation last year, where the agency determined a lack of adequate procedures for receiving, reviewing and evaluating complaints.
Complaint Handling software can streamline the process for companies, making it simple to track incoming complaints, assess risk of complaints and immediately generate corrective actions to investigate and resolve the problem.
3. Poor Corrective Action Processes
The FDA cited hundreds of companies last year for this problem. Solving this problem is as simple as setting up automated workflows within your Quality Management System (QMS) or FDA Compliance Management System.
You can create different workflow templates for various types of events such as complaints, nonconformances and equipment issues, ensuring:
- Automatic routing of corrective actions through review, root cause analysis, action taken and verification.
- Escalation of overdue corrective actions to supervisors when key milestones are overdue.
- Effective prioritization and handling of corrective action requests through risk-based filtering and final verification.
4. Insufficient Supplier Controls
Every year, the FDA cites dozens of companies for inadequate procedures to ensure products purchased from suppliers conform to requirements. Managing suppliers is difficult in our complex global supply chain, which is why market leaders use Supplier Management tools to increase visibility and extend compliance to supply chain partners.
These tools help by allowing you to:
- Establish custom inspection profiles and track inspection data.
- Maintain comprehensive supplier records, including compliance certificates, materials received and risk level associated with each supplier.
- Assign corrective actions to suppliers, even giving them secure Web-based access to the QMS to involve them in your compliance process.
5. Audit Problems
Lack of or inadequate procedures for quality audits is a classic FDA compliance citation. Audit tools within the QMS are essential for keeping your audit schedule on track, consolidating checklists for easy access and ensuring prompt, efficient follow-up of any internal findings.
By streamlining the audit process with automated processes, you can save many hours on preparing for audits and processing findings. Not only that, you’ll also be better positioned to avoid many of the other citations listed in this post.
6. Training Procedures
Training issues are a surprisingly common FDA citation in life sciences industries. Employee Training tracking tools are a key antidote to this problem, helping you record your training efforts and ensure that training requirements are updated alongside other changes to processes, specifications or work procedures.
7. Issues with Laboratory Controls, Monitoring and Calibration
This is a pretty big category, encompassing citations such as lack of or inadequate procedures for:
- Process validation
- Process control
- Environmental monitoring
- Preventing drug contamination
- Sanitation and maintenance
- Regular calibration of mechanical equipment
Looking at this list, it’s not entirely surprising that the FDA recalls thousands of drugs and medical devices every year. Getting your processes in order takes some work, but leveraging the QMS can make it easier. The steps you take now to ensure tighter process control will set you up for success across a range of outcomes, from preventing public safety issues to reducing waste to increasing profits.