A disaster on the scale of hurricane Harvey probably has not occurred since adoption of the Drug Quality and Safety Act. This is the first time that FDA regulated 503B Outsourcing Facilities have had to address flooding, loss of power, or other weather related issues that impact or could impact building and facilities, and/or equipment regulated by cGMPs.
Hurricane Harvey is no longer a hurricane, the flood waters are receding, and life is starting to get back to normal. But if you are a 503A or B, with a facility that was without power and flooded with storm water, how do you insure that your facility recovers from the insanitary conditions created by the storm damage?
Without power the controlled storage conditions required by USP were not met. Without power the clean rooms were idled for days or weeks. Storm water entering the facility may have simply caused water damage which brings a potential for mold – or worse, storm water mixed with raw sewage, pesticides or other chemicals may have contaminated the facility.
How will you respond when the FDA inspector at your next inspection asks to see your disaster recovery plan and the actions you took to startup and resume compounding operations of your facility? This plan should follow a logical methodology:
Evaluation: Once you regained access to the facility following the hurricane what was the status of the facility? This includes raw materials, building and facility, and clean rooms.
Risk Assessment: Based on your evaluation, what are the potential risks for insanitary conditions, and impact to resuming sterile compounding?
Action Plan: What actions are necessary to mitigate the risks identified in your evaluation and risk assessment? What is required to safely resume compounding medications? What is the logical sequence of execution to properly plan out the entire scope while minimizing rework.
Execution: Execute the Action Plans. Be aware that as you execute you may find additional damage and thus more work necessary to resume operations. This may move you back to an earlier stage such as evaluation, risk assessment, or developing new or revising action plans.
Review and approval: As the action plans are completed, it is time to do an after action review to ensure that all the work is completed, and post work testing (for example microbial testing) is completed in order to fully certify the facility is ready to resume operations.
Have questions contact Performance Validation.