As states begin to ease restrictions, the dawn of a new sense of normalcy is on the horizon. For FDA and USDA regulated industries, that new normal requires immense planning and preparation, before returning to pre-pandemic operations.
- Is your restaurant or retail facility, staff and management ready for the new regulatory and customer-expected norms?
- Have you updated your facility and staff hygiene operations, and were Good Manufacturing Practices (GMPs) change controls incorporated?
- Employees are returning to the line, are they being retrained to safely operate their equipment?
- Have you completed a “deep cleaning” and swabbing of key areas of the facility, equipment and “high touch” surfaces to verify your cleaning has been effective?
- Does your current outside testing laboratory have the “right” capabilities to address the post-COVID-19 requirements?
- Are all equipment calibrations current and has any equipment that has been relocated also been requalified?
- Do all of your employees understand and comply with sanitation and hygiene standards?
- Is it time for refresher or annual GMP training?
- Are you in need of new overseas ingredient suppliers and have they been vetted against GMP requirements, the Foreign Supplier Verification Program (FSVP) Rule, and US FDA Preventive Control regulations?
- As your supplement facility returns to work, how will you notify FDA of stored Serious Adverse Events (SAEs)?
- Did you register your facility and list your drug products as you began producing hand sanitizers?
- If you were manufacturing sanitizers and face masks during the emergency period, are you prepared to operate in accordance with the full set of GMP requirements?
There are numerous challenges to reopening, regrouping and ensuring you compliance with federal and state regulations are in order. EAS Consulting Group along with our parent organization, Certified Laboratories, offers remote assistance for all these challenges and more. Our over 150 consultants are former senior FDA, USDA, OSHA, EPA and CBP officials and industry executives who offer unparalleled expertise as well as wide-ranging ISO 17025 laboratory testing capabilities. As such, EAS can assist you with how to best address and weather unexpected operational changes, whether it is being driven by the market, government regulations or COVID-19 in a timely, ethical and cost-efficient manner.
Contact EAS today to understand your regulatory requirements and learn how we can be of assistance.
Posted in COVID-19.