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CGMP Compliance Challenges with COVID-19 Infection

June 25, 2020  •  Blog  •  Reginald Neal, Senior Consultant
Posted In Compliance News & Insights – Biologics Consulting  •  Tagged CGMP, Contamination, COVID-19 – Biologics Consulting – Blog, Manufacturing, Personnel, SARS-CoV-2

With the advent of Coronavirus (COVID-19) disease as a public health emergency, FDA has issued new guidance on COVID-19 infection in employees [Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing/ Guidance for Industry June 2020] , providing recommendations for enhanced personnel management and controls to mitigate the risk of SARS-CoV-2 [e.g. the virus which causes COVID-19 disease] product contamination.

Personnel responsibilities and exclusion from direct contact with components, drug product containers, closures, in-process materials, and drug products are currently promulgated as a legal requirement under 21 CFR part 211 Finished Pharmaceuticals Current Good Manufacturing Practice [CGMP] regulations and 21 CFR part 600 Biological Products regulations.

As addressed in this new guidance, the following points are to be considered:

  • Review and assessment of procedural controls in place to comply with cGMP regulation 21 CFR 211.28(d) “personnel responsibilities,” relevant to strategies warranted to screen personnel to ensure exclusion of personnel from manufacturing that may be infected with SARS-CoV-2 virus.
  • Review and assessment of facility controls in place to prevent the contamination of equipment or product by personnel in line with the stability of SARS-CoV-2 virus for several hours to days in aerosols and on surfaces that could have an adverse effect on product quality.
  • Review and assessment of manufacturing facility viral control strategies in place as it relates to the new coronavirus. Specifically, for biologics, the assessment should include the potential of the production cell line to replicate SARS-COV-2 and virus studies for effective detection and clearance of SARS-COV-2
  • Review and assessment of cleaning and sanitization procedures in production and nonproduction areas to mitigate the risk of transmission among employees and subsequent contamination of product or materials by COVID-19 infected manufacturing personnel.
  • Review and assessment of procedures in place for the restriction of personnel [21 CFR 600.10 (c)] whose presence if infected with SARS-Cov-2 could adversely affect the safety of the product.
  • Review and assessment of COVID-19 infection risk management and proactive plans in place to protect materials (APIs and Drug product), components, drug container closures, in-process materials, and/or drugs from employees as it relates to the new coronavirus.- The materials “if determined to be adversely affected in terms of safety and quality must not be released for further manufacturing or for distribution. Such items must be properly dispositioned (e.g., quarantined pending appropriate re-evaluation or reprocessing, or rejected)”.
  • Development of an action plan in the event of a potential or actual SARS-Cov-2 viral contamination for maintaining drug supply

Food and Drug Administration (FDA). Center for Drug Evaluation and Research (CDER). Center for Biologics Evaluation and Research (CBER). (June 2020). Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing / Guidance for Industry. Retrieved from source.