BY LYNNE ENSOR - VICE PRESIDENT, TECHNICAL, PAREXEL
Global manufacturers and regulators are facing new challenges during the SARS-CoV-2 pandemic to maintain supply chains, and avoid shortages, of drugs, biologics and medical devices. Numerous United States governmental organizations, such as CDC, EPA, OSHA and the FDA, have been developing and providing recommendations and guidance to industry to assist manufacturers of these critical products with maintaining production operations. On June 19, 2020, FDA released a Guidance for Industry (GFI) entitled Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing.
The GFI provides recommendations to drug and biological product manufacturers to prevent contamination of drug products, while still allowing manufacturers to retain operations that produce safe and effective drug products. Reference to applicable current good manufacturing practice (CGMP) regulations and recommendations are made regarding how to restrict sick employees from production areas. These include:
- 21 CFR 211.28 (d), “Personnel responsibilities” (for drug products )
- ICH guidance for industry Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (APIs), section III, Personnel (3) (for APIs)
- 21 CFR 212.30 (for positron emission tomography drugs)
- 21 CFR 600.10(c)(1), “Restrictions on personnel – (1) Specific duties (for biological products),
It is critical for manufacturers to monitor employees who perform manufacturing functions and restrict those who are COVID-19 infected, have been exposed to others who are COVID-19 infected or demonstrate COVID-19 symptoms. Although this GFI does not focus on the treatment of infected individuals, FDA recommends following CDC recommendations for isolation of those individuals, including potential “consultation with health care providers”. The guidance also highlights the need for employees to practice good sanitization and health habits, such as those outlined in the CFR and ICH Q7. To ensure compliance and product safety and quality, review of CGMP regulations associated with facility and equipment sanitization practices, as well as restriction of ill employees from production areas, is highly recommended.
Drug product manufacturers are expected to follow quality risk management principles to prevent or mitigate any potential adverse effects on the safety and quality of drugs from anyone involved in manufacturing who is either infected or could potentially be infected with COVID-19. Additionally, protocols should be in place should viral contamination occur to “promptly clean, disinfect, sanitize and, if necessary, sterilize” impacted areas and equipment.
This GFI stresses the importance of mitigating the risk of a sick employee from adversely impacting the safety and quality of drugs. The pandemic has brought to the forefront the potential consequences that microorganisms, such as SARS-CoV-2, can have on the drug and biologic product supply chain. However, controls for drugs, facilities, processes and manufacturers should always be in place to mitigate the impact that a sick employee or microorganisms, such as during a viral or bacterial outbreak, could have on the safety and quality of a product.
This GFI is intended to only be in effect for the duration of the COVID-19 public health emergency. Some experts have predicted that it may be months or years until the following are achieved:
- a vaccine is widely available for SARS-CoV-2 prevention, with manufacturing capabilities to support a broad, global scale of inoculation
- a comprehensive, scientifically based understanding of the virus, its mechanism(s) of transmission, and the human immune response to COVID-19 infection (e.g., if memory immunity from an initial COVID-19 infection can prevent reinfection), OR
- effective preventative measures, which allow for greater human interactions until a vaccine is broadly available to the global population (or at least available specifically to those involved in drug and biologic product manufacturing), are established and implemented consistently.
Therefore, should this pandemic persist, this GFI could remain in effect for years. Now more than ever, it is critical for manufacturers to be vigilant regarding potential COVID-19 exposure of their employees and/or products to ensure continuity of drug and biological product supply chains. Conforming to the expectations in this GFI, and the appropriate parts of the Code of Federal Regulations, will assist in ensuring public safety and regulatory compliance during the COVID-19 pandemic.
Parexel offers a COVID-19 Risk Mitigation Assessment Service which can provide an organization with a comprehensive risk mitigation strategy to minimize virus transmission to protect employee and customer safety at your facility. To learn more view our free complimentary assessment or download our factsheet.