How To Avoid FDA 483 in 2022 and Beyond!
March 23rd, 2022 // 8:30 pm @ jmpickett
cGMP regulations have not changed a lot in the past few years, but FDA expects you to be in full compliance with cGMPs more than ever. With Turbo EIR and other computerized systems, FDA inspectors have time to focus on pharmaceutical and medical device industry trends and focus on more risk-based criteria.
Pharmaceutical industry insiders say we should be more prepared for FDA auditors finding noncompliance issues in our quality systems. By focusing on this area, we can reduce risk in our businesses and lower the chances of receiving an FDA 483. Remember, monitoring your plant’s quality systems and responding to quality metrics that were reported can avoid many FDA compliance problems.
Procedures Not Written Or Not Fully Followed
Let’s take a close look at a few common FDA 483 observations for 2022 and how to reduce them:
For a drug company to prove to FDA that it is operating with the highest possible compliance standards, SOPs must be clearly written. They also need to be modified and maintained consistently. A pharma company can run into FDA compliance problems when document control systems are still based on paper or spread over several locations. Other problems arise when the firm doesn’t closely track signatures and approvals.
Upcoming Webinar – How To Handle An FDA Drug Recall
We all know that SOPs for drug manufacture are complex and challenging to maintain. But FDA is looking more closely in 2022 on enforcement and compliance, so SOPs need to be kept in order.
Many SOPs are very complex and can be tough to read and follow every day. If there is too much complexity in the SOP, there is a higher risk of mistakes, and FDA will notice these issues during their inspection.
Your company can avoid this observation by simplifying SOPs as much as you can. You may also consider re-engineering your procedure, or use photos and drawings to add clarity and reduce confusion. Plus, you might reduce the number of staff involved in the work.
Using an electronic SOP system is essential to automate SOP creation and changes. When critical documentation is maintained electronically and securely, many SOP 483 observations are avoided.
Discrepancies And Failures In Investigations
In 2022, CAPA, investigations, and deviations handling are regular issues for drug, device, and biologic companies. Remember that FDA tells us that all deviations from procedures maintained in writing have to be completely investigated. And investigation results needed to be thoroughly documented.
2016 data informs us that investigations of discrepancies in production record review was a common 483 observation. If a drug company cannot ID a root cause and make a record of it, FDA will probably view the investigation as incomplete.
A proper closed-loop investigation set up should include:
- Identifiction
- Prioritization
- Assignment and Acknowledgement
- Investigation
- Correction
- Implementation
- Verification
- Close
After the investigation, the drug company may identify a root cause, such as human error. But there needs to be additional analysis for there to be a highly effective CAPA. At that time, you should add another step to ID the real root cause.
Fortunately, investigating and identifying quality events is made a lot simpler with good quality management software so your company can automate the CAPA process.
Upcoming Webinar – How To Handle An FDA Drug Recall
