On Friday, June 19th, the FDA issued a guidance document explaining what manufacturers of drugs and biological products should do, if and when, employees become infected with COVID-19. The recommendations in the guidance document, entitled Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing, touch on:
- Manufacturing controls to prevent contamination of drugs
- Risk assessment of SARS-CoV-2 as it relates to drug safety or quality
- Continuity of manufacturing operations
Manufacturing Controls to Prevent Contamination of Drugs
Regardless of the presence of a public health emergency, FDA expects drug manufacturers to “prevent or mitigate adverse effects on the safety and quality of drugs from an infected or potentially infected employee engaged in drug manufacturing.” As such, the Agency recommends that manufacturers review the current good manufacturing practice (cGMP) regulations and recommendations regarding the restriction of sick employees from production areas.
As such, manufacturers should be vigilantly monitoring all employees who perform drug manufacturing functions and have been exposed to anyone with a confirmed or suspected case of COVID-19. Any employees who “(1) test positive for COVID-19 (regardless of whether they have symptoms) or (2) have symptoms of COVID-19 must be excluded from drug manufacturing areas in accordance with the applicable cGMP requirements referenced above.” These employees should not return to work until the CDC’s criteria to for home isolation have been met and they have been cleared by a health care provider.
When manufacturing any drug or biological product, it is extremely important to ensure that employees are practicing good sanitation and health habits, as outlined in 21 CFR 211.28(b). The Agency also reminds manufacturers that, under section 501(a)(2) of the FD&C Act, “a drug that is not manufactured, processed, packed, or held in conformity with current good manufacturing practice to assure that the drug meets certain quality and purity standards is considered adulterated.”
To help prevent the spread of COVID-19 among employees and the contamination of drugs/materials, the following precautionary measures should be taken by all manufacturers:
- Clean and sanitize nonproduction areas (such as offices, elevators, break rooms, changing rooms, and restrooms) more frequently.
- Update existing procedures to institute more frequent cleaning, sanitization, and/or sterilization of surfaces in the production areas, particularly surfaces that are contacted frequently, such as door handles, equipment latches, bench/counter tops, and control panels. Special attention should be paid to sanitizing/sterilizing equipment and product-contact surfaces.
- Consider expanding existing procedures to include using gloves, face masks, and/or gowning where such measures were not previously required.
- Consider further restrictions on employee access to any manufacturing area, beyond that required by cGMP regulations and recommended by Agency guidance and normal practice, to limit the possibility of contamination.
Impact of COVID-19 on Drug Safety, Quality, and Disposition
Currently, the FDA is not aware of any drugs that have been contaminated by the virus or of any information indicating that the spread of COVID-19 is associated with drugs. However, given that SARS-CoV-2 is a novel coronavirus, FDA is asking manufacturers to “evaluate whether it poses new risks in the context of their specific drugs, facilities, processes, and manufacturing controls.” As such, manufacturers should conduct a risk assessment considering both the known characteristics of the virus as well as the drug type(s) to determine if SARS-CoV-2 could adversely affect the safety or quality of their materials, components, drug product containers and closures, in-process materials, and drugs if they were to become contaminated with the virus.
Lots or batches of any product found to be adversely affected in terms of safety and/or quality should be properly disposed of and should not, under any circumstances, be released or distributed.
To ensure compliance with all GMP requirements, and in accordance with 21 CFR 211.22, 21 CFR 211.100, and 21 CFR 212.20, “manufacturers must ensure that all evaluations to determine if drug safety or quality were adversely affected, as well as any follow-up and changes, are approved by the manufacturer’s quality unit and documented within the manufacturer’s quality management system.” In addition, active pharmaceutical ingredient (API) manufacturers should have procedures in place to ensure that all evaluations to determine if API safety or quality were adversely affected are approved by the manufacturer’s quality unit and are documented in its quality management system (QMS).
Maintaining the Drug Supply
In order to avoid further spread of the virus and potential contamination of the drug product, regardless of the presence of any symptoms, any worker who has tested positive or has been exposed to someone who has tested positive for COVID-19, should notify their supervisor and stay home. Furthermore, any worker who has symptoms associated with COVID-19, such as fever, cough, shortness of breath should also stay home. Workers at drug manufacturing facilities have been deemed essential workers during the COVID-19 pandemic, and it is critical that drugs continue being manufactured during this public health crisis. As such, manufacturers should take steps to implement social distancing procedures to minimize exposure and transmission amongst employees.
“In addition to taking steps to prevent adverse effects of employees infected with COVID-19 on the safety and quality of drugs, drug manufacturers of medically necessary human drugs should also implement contingency production plans if COVID-19 infections result in high absenteeism at drug manufacturing facilities during this public health crisis.” If possible given the company’s technology, manufacturers should consider allowing certain employees who are quarantined and recovering to work remotely, but only on certain manufacturing functions, such as batch record analytical record review and investigation.
Who Does This Apply to?
This is relevant for all companies that manufacture a drug or biological product. Whether you manufacture your product(s) yourself or outsource this function to a contract manufacturing organization (CMO), you are still responsible for ensuring the safety and quality of your product. If steps are not taken to prevent the spread of COVID-19 through the workforce and the contamination of drugs, it is likely that the drug supply will be disrupted. In the event that this occurs, manufacturers should contact the FDA immediately. However, this situation can and should be avoided at all costs. Don’t wait for something bad to happen to take steps to avoid future outbreaks; make sure you are in compliance now and avoid the headache of dealing with these issues at all.
We can help minimize your risk of a COVID-19 outbreak in your manufacturing facilities while also ensuring you remain compliant with all applicable GMPs. To learn more about our services and how we can help you, contact us today.
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