In early 2020, while COVID-19 was wreaking havoc on public health and safety, the FDA took the unprecedented step of postponing domestic and foreign inspections. The FDA’s risk-based inspection programs have been the cornerstone of the FDA’s oversight and regulation of product manufacturing. The FDA made the decision to postpone these facility inspections to protect the health and well-being of FDA staff, and in response to industry’s concerns about visitors at FDA-inspected facilities.
As we begin the journey to normalcy in our daily lives and work, the FDA is looking to do the same and recently indicated they would start resuming inspections. At the time of this writing, the timeline is unknown. As a result, we are all waiting anxiously for the inevitable. But, if the FDA showed up tomorrow, would you be ready?
Paradigm Shift and How to Adjust
The pandemic has caused companies to deviate from procedures and adapt to new ways of conducting business. As such, some facilities may not be “inspection ready at all times.” Deviations and process issues that require investigations are inevitable, especially as we adapt to the realities of the pandemic. No matter how hard a company strives to put in place perfect SOPs, systems, and processes, it is virtually impossible to predict every possible failure type and to totally prevent incidents from happening.
To stay ahead of these potential problems and delays, corrective and preventive action (CAPA) plans are essential in reducing reoccurrences of some of the more common deviations and incidents that seem to recycle every few months. When a deviation or incident does arise, whether in production or after product launch, having a sound CAPA process in place to review documentation, and roles and responsibilities of people and technology involved in the process, helps companies to find, fix, and validate problems without the risk of losing a significant amount of dollars, or worse yet, risk to the patient.
An industry average deviation costs range from $25,000 to $55,000, yet they can top $100,00 or more per deviation if product loss is involved. Investigating one deviation alone can cost a company thousands of dollars. When considering the cost to produce and release batches, subsequent employee turnover, and potential downtime, cost can increase exponentially.
Common Pitfalls and Root Cause Analysis
Investigations are one of the most important quality activities in any GMP organization. They are also repeatedly near the top of the list of the most frequently cited issues in observations, warning letters, and consent decrees from the FDA and other regulatory authorities.
Common investigation system issues we see include:
- Investigations raised well after the event occurred
- Investigations taking too long to complete or overdue in violation of standard procedures
- Premature deviation closeout before identifying root cause
- True or contributing root causes not identified
- Overdue or extended CAPAs without justification
- Frequency of root causes such as human error
- Reoccurrence of deviations and incidents
- Lack of adequate trending and reporting of performance metrics to management
Many investigations are falsely classified as human error (e.g., individuals not following SOPs or work instructions accurately). However, when the same or related problem has occurred on several occasions and with different employees, this is a clear indication that something other than human error is at play and the true root cause has not been identified. While human error may be a contributing factor to the issue, digging deeper into the source of this human error is further warranted (e.g., robustness of training program, understandable processes, appropriate reviews, etc.). Effectiveness checks are essential in determining if a CAPA was effective in preventing the non-conformance from occurring again. If the CAPA is found to be not effective during an effectiveness check, a new investigation could be required and a more robust CAPA put into place.
An investigation should be launched from the outset of a deviation or incident with the intention of establishing true root cause and identifying appropriate CAPAs. As time goes on, individual recollections get hazy and the opportunity to implement corrective measures passes. Could the issue impact other systems or products that have been released? Too often, we see that companies that delay investigations snowball into an almost insurmountable backlog. Timeliness is not only a mechanism to protect patient safety, but a way to improve the efficiency of an organization’s operations.
Expert Support
Whatever situation your company finds itself in, the professionals at ProPharma Group are here to help. We utilize a unique and tested personnel onboarding process that has helped to free up training and management time for numerous clients. With our process, our teams are able to work to capacity much faster giving our clients peace of mind that the work is getting done! If working remotely is your preference, ProPharma Group can utilize platforms, such as WebEx, Zoom, or Teams to coordinate meetings, and to communicate what documentation/information is needed for the investigation to continue to close. We also seamlessly integrate into your quality system and act as an extension of your team.
For onsite work, ProPharma Group will adhere to site, local, and state polices and established COVID restrictions, and will ensure the right people are on site to support your investigation activities. Contact us today to learn more about our team of experts and how we can help with all your investigation backlog needs and the project management of such efforts.
