FDA Issues Guidance On What To Do if Employees Test Positive for COVID-19

The Guidance, which can be found here contains “recommendations” on how to meet CGMP requirements during the pandemic. Among the most important “recommendations” are the following:

• Manufacturers should require that any workers who have COVID-19 symptoms – such as fever, chills, cough, or shortness of breath, or sore throat – notify their supervisors and stay home. (The CDC has published a list of symptoms often associated with COVID-19. You can find it here.) Further, workers who have been exposed or potentially exposed to COVID-19 at work, home, or elsewhere should immediately notify their supervisors.
   
• Employees who test positive for COVID-10 – regardless of whether they have symptoms – must be excluded from all drug manufacturing areas and should not return to work until “the CDC’s criteria to discontinue home isolation are met….”
   
• Drug manufacturers must evaluate the adequacy of their CGMP controls already in place to protect materials, components, drug container closures, in-process materials, and/or drugs from sick employees in the context of the new coronavirus.
   
• Manufacturers should clean and sanitize nonproduction areas such as office, elevators, break rooms, changing rooms, and restrooms more frequently.
   
• Manufacturers should update existing SOPs to institute more frequent cleaning, sanitization, and sterilization of surfaces in production areas, including especially door handles, equipment latches, bench/countertops, and control points.
   
• Manufacturers should consider expanding existing procedures to include using gloves, face masks, and/or gowning where such measures were not previously required.
   
• Manufacturers should also consider further restrictions on employee access to any manufacturing areas beyond those required by CGMP requirements.

If a potential or actual viral contamination event is identified, FDA is “recommending” the following:

• Manufacturers must “promptly clean, disinfect, sanitize, and, if necessary, sterilize affected equipment, surfaces, production areas, and facilities before resuming manufacturing.”
   
• If supplies of single-use (as opposed to disposable) masks and other PPE are low, manufacturers should prioritize these for use in sterile manufacturing operations. To mitigate supply issues, manufacturers may need to re-sterilize or disinfect masks and PPE as appropriate.
   
• Manufacturers must ensure that all evaluations of the production controls, including risk assessments, follow-up, and changes are approved by the quality unit and documented within the quality management system.
   
• Lots or batches of components, drug product containers and closures, in-process materials, and/or drug products determined to be adversely affected in terms of safety and quality must not be released for further manufacturing or for distribution. They must be properly “dispositioned” by which FDA means quarantined pending appropriate re-evaluation or reprocessing, or rejected.
   
• Lots or batches of APIs determined to be adversely affected must not be distributed and must likewise be “dispositioned.”
   
• Finally, if taking any of these steps will create a possible drug shortage, FDA urges that affected companies contact the FDA as soon as possible.