Posted 19 June 2020 | By
A new guidance from the US Food and Drug Administration clarifies how manufacturers of drugs and biological products should address COVID-19 infection in their employees.
Generally speaking, employees who are ill or infected with SARS-CoV-2, the novel coronavirus, must be excluded from drug manufacturing areas and not permitted to return until they have met home isolation criteria established by the US Centers for Disease Control and Prevention (CDC). This guidance holds true for individuals who have a positive test for COVID-19, even if they do not have symptoms, and for individuals with COVID-19 symptoms, regardless of testing status. Evaluation of the employee’s status should be made “in consultation with healthcare providers,” according to the guidance, which is immediately effective for the duration of the public health emergency of the COVID-19 pandemic.
Since drug manufacturing workers are considered critical infrastructure workers during the pandemic, they fall under special CDC guidance about when they may continue to work following an exposure or potential exposure to COVID-19. Employees should report any exposures or potential exposures to their supervisors, who should follow the CDC guidance. Drugmakers should consider implementing CDC-recommended social distancing measures that minimize the risk of transmission of COVID-19.
The guidance points to current good manufacturing practices (CGMPs) that already address infected or potentially infected employees who are engaged in drug manufacturing. Specifically, FDA cites 21 CFR 211.28(d), that mandates that an individual with apparent illness that may adversely affect drug product safety or quality be excluded from the production area and process until the individual can be medically evaluated, or the condition has been deemed corrected. Under this regulation, personnel are required to report any health conditions that could adversely affect drug safety or quality to their supervisors.
For biological products, 21 CFR 600.10(c)(1) similarly requires that individuals who could adversely affect the safety or purity of a product be restricted from rooms where manufacturing is in progress.
Positron emission tomography drugs are governed by 21 CFR 212.30, which lays out a general requirement to prevent “contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adverse effect on product quality.”
The International Council on Harmonisation (ICH) has guidance for production of active pharmaceutical ingredients (APIs) that mirrors the drug products requirements in the US Code of Federal Regulations.
The guidance also recommends that employees continue to practice good sanitation and health practices, and that ongoing risk management consider known characteristics of SARS-CoV-2. Cleanroom processes such as air filtration and movement should be reviewed, and manufacturers should consider the potential for cross-contamination. In some cases, says the guidance, current controls may adequately address any additional risk from SARS-CoV-2.
Biological product manufacturers need to conduct their risk assessments with an eye to such factors as the potential that a production cell line could itself replicate SARS-CoV-2 and whether current virus testing would detect the novel coronavirus, among others.
Manufacturers can take specific steps to minimize the risk of workplace transmission of COVID-19, including more frequent cleaning and sanitizing of non-production areas and high-touch areas within production areas; expanding use of gloves, masks, and gowns; and further restricting any unnecessary employee access to manufacturing areas.
Any potential or actual coronavirus contamination should trigger thorough cleaning, disinfecting, sanitization, and – if necessary – sterilization of all affected areas and equipment before manufacturing begins again. All evaluations of production controls, including COVID-19-focused risk assessments, should be approved by a drug or API manufacturer’s quality unit and documented within the quality management system.
To maintain the drug supply, drugmakers of medically necessary human drugs should have contingency production plans in place should they see a spike in COVID-19 cases and high absenteeism. The contingency plan could include provisions for remote work, where feasible. Any anticipated disruption in the drug supply must be reported to FDA immediately; the guidance provides contact links for each FDA regulatory branch.
Generally speaking, employees who are ill or infected with SARS-CoV-2, the novel coronavirus, must be excluded from drug manufacturing areas and not permitted to return until they have met home isolation criteria established by the US Centers for Disease Control and Prevention (CDC). This guidance holds true for individuals who have a positive test for COVID-19, even if they do not have symptoms, and for individuals with COVID-19 symptoms, regardless of testing status. Evaluation of the employee’s status should be made “in consultation with healthcare providers,” according to the guidance, which is immediately effective for the duration of the public health emergency of the COVID-19 pandemic.
Since drug manufacturing workers are considered critical infrastructure workers during the pandemic, they fall under special CDC guidance about when they may continue to work following an exposure or potential exposure to COVID-19. Employees should report any exposures or potential exposures to their supervisors, who should follow the CDC guidance. Drugmakers should consider implementing CDC-recommended social distancing measures that minimize the risk of transmission of COVID-19.
The guidance points to current good manufacturing practices (CGMPs) that already address infected or potentially infected employees who are engaged in drug manufacturing. Specifically, FDA cites 21 CFR 211.28(d), that mandates that an individual with apparent illness that may adversely affect drug product safety or quality be excluded from the production area and process until the individual can be medically evaluated, or the condition has been deemed corrected. Under this regulation, personnel are required to report any health conditions that could adversely affect drug safety or quality to their supervisors.
For biological products, 21 CFR 600.10(c)(1) similarly requires that individuals who could adversely affect the safety or purity of a product be restricted from rooms where manufacturing is in progress.
Positron emission tomography drugs are governed by 21 CFR 212.30, which lays out a general requirement to prevent “contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adverse effect on product quality.”
The International Council on Harmonisation (ICH) has guidance for production of active pharmaceutical ingredients (APIs) that mirrors the drug products requirements in the US Code of Federal Regulations.
The guidance also recommends that employees continue to practice good sanitation and health practices, and that ongoing risk management consider known characteristics of SARS-CoV-2. Cleanroom processes such as air filtration and movement should be reviewed, and manufacturers should consider the potential for cross-contamination. In some cases, says the guidance, current controls may adequately address any additional risk from SARS-CoV-2.
Biological product manufacturers need to conduct their risk assessments with an eye to such factors as the potential that a production cell line could itself replicate SARS-CoV-2 and whether current virus testing would detect the novel coronavirus, among others.
Manufacturers can take specific steps to minimize the risk of workplace transmission of COVID-19, including more frequent cleaning and sanitizing of non-production areas and high-touch areas within production areas; expanding use of gloves, masks, and gowns; and further restricting any unnecessary employee access to manufacturing areas.
Any potential or actual coronavirus contamination should trigger thorough cleaning, disinfecting, sanitization, and – if necessary – sterilization of all affected areas and equipment before manufacturing begins again. All evaluations of production controls, including COVID-19-focused risk assessments, should be approved by a drug or API manufacturer’s quality unit and documented within the quality management system.
To maintain the drug supply, drugmakers of medically necessary human drugs should have contingency production plans in place should they see a spike in COVID-19 cases and high absenteeism. The contingency plan could include provisions for remote work, where feasible. Any anticipated disruption in the drug supply must be reported to FDA immediately; the guidance provides contact links for each FDA regulatory branch.
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FDA: Follow CDC guidance for COVID-infected employees - Regulatory Focus
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