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  • Good Manufacturing Practice (GMP) Considerations for Responding to COVID-19 Infection in Employees in Drug & Biological Products Manufacturing

    In June 2020, FDA released Guidance for Industry (GFI) entitled “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing”. FDA is issuing this guidance to provide recommendations to drug and biological product manufacturers regarding:

    • 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

    Drug manufacturers are expected to prevent or mitigate potential adverse effects on the safety and quality of drugs from an infected or potentially infected employee engaged in drug manufacturing. During the COVID-19 public health emergency, drug manufacturers should review the following current good manufacturing practice (CGMP) regulations and recommendations regarding the restriction of sick employees from production areas:

    For drug products, 21 CFR 211.28(d), “Personnel responsibilities,” requires that:

    Any person who is shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.

    For active pharmaceutical ingredients (API), the ICH guidance for industry Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients recommends:

    Personnel suffering from an infectious disease or having open lesions on the exposed surface of the body should not engage in activities that could result in compromising the quality of APIs. Any person is shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions should be excluded from activities where the health condition could adversely affect the quality of the APIs until the condition is corrected or qualified medical personnel to determine that the person’s inclusion would not jeopardize the safety or quality of the APIs.

    For positron emission tomography (PET) drugs, 21 CFR 212.30:

    Facilities. You must provide adequate facilities to ensure the orderly handling of materials and equipment, the prevention of mix-ups, and the prevention of contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adverse effect on product quality.

    For biological products, 21 CFR 600.10(c)(1):

    Persons whose presence can affect adversely the safety and purity of a product shall be excluded from the room where the manufacture of a product is in progress.

    Drug manufacturers should vigilantly monitor employees who perform drug manufacturing functions and have been exposed to others with confirmed or suspected COVID-19 for symptoms of COVID-19 infection.

    • Employees (1) who 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. FDA recommends that such employees should not return to work in such areas until the CDC’s criteria to discontinue home isolation are met, in consultation with health care providers.
    • To ensure compliance with CGMP requirements, drug product manufacturers must ensure that employees practice good sanitation and health habits, in accordance with 21 CFR 211.28(b).
    • Additionally, the FDA recommends that API manufacturers ensure that employees practice good sanitation and health habits as described in ICH Q7, Section III.B., Personnel Hygiene (3.2).
    • Drug manufacturers, including API manufacturers, should be aware 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 practices to assure that the drug meets certain quality and purity standards are considered adulterated.

    In accordance with quality risk management principles, drug manufacturers are expected to take the following steps to prevent or mitigate potential adverse effects on the safety and quality of drugs from an infected or potentially infected employee engaged in drug manufacturing:

    • Evaluate the adequacy of the 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 this new coronavirus.
    • To ensure compliance with CGMP requirements, drug product manufacturers must ensure that all evaluations of the production controls (including risk assessments), follow-up, and changes are approved by the manufacturer’s quality unit and documented within the manufacturer’s quality management system, in accordance with21CFR 211.22, 21 CFR211.100, and 21CFR 212.20. (See also 21 CFR 211.113.).
    • Additionally, FDA recommends that API manufacturers have procedures in place to ensure that all evaluations of production controls (including risk assessments), follow-up, and changes are approved by the manufacturer’s quality unit and documented within the manufacturer’s quality management system (see ICH Q7, section II., Quality Management, and section XIII., Change Control).

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