Covid-19 & Pharmaceutical manufacturing: the challenges for production quality, safety and continuity

by Alessio Rosati
Sterility Assurance Executive Consultant – PQE Group

The current COVID19 outbreak, which raised from the first limited number of cases observed in China on November 2019 up to a rapidly worldwide spreading pandemic, is still posing significative challenges to national finances and particularly to some essential, and strategic manufacturing activities, like pharmaceutical industry.

Production continuity: FDA addressing covid-19 related issues

The challenges for pharmaceutical manufacturers are mainly related to the fact that production and supply continuity of the most products can’t be interrupted nor decreased, regardless organizational and outbreak containing reason. In this perspective, it becomes clearly essential for pharmaceutical manufacturers to implement control, procedural and organizational strategies aimed to:

  • minimize the risk of Covid19 transmission among employees
  • assess the likelihood and the impact that Covid19 contamination risk could pose for the health and safety of their products (and hence of the patients)
  • ensure the required supply continuity
  • All these issues were promptly addressed in the FDA Guidance for Industry(1) released on June 2020, where guidelines and requirements are described to ensure the safety of the manufacturing environments, products health and supply continuity.
    Going deeper in the Guidance, it is important to highlight here the issues and challenges that pharmaceutical manufacturers are requested to face.

Manufacturing controls to prevent contamination of drugs.

Taking into account what is so far known about Covid19 environmental stability and infection routes, the pharmaceutical manufacturers are requested to improve overall oversight and control measures on personnel hygiene and sanitisation habits, in compliance with the already existing regulatory requirements for drug products [21 CFR 211.28(d)], APIs production [ICH Q7, Section III.3], PET drugs [21 CFR 212.30] and biological products [21 CFR 600.10(c)]. The control measures in place should not only be assessed for their effectiveness on limiting Covid19 transmission, but also to verify if improvements in routine areas (and equipment) sanitization and cleaning procedures are needed.

In this perspective, manufacturers should evaluate the adequacy of their control measures to protect materials and products from Covid19 contamination at all stages of the manufacturing process and implement dedicated preventive actions, if resulting to be required. It goes without saying that the application of the risk management principles are strongly recommended to perform a science-based and exhaustive assessment of the contamination risk.

Particularly relevant from this point of view, the manufacturing processes of biological products should be assessed for the risk of Covid19 contamination of materials, intermediates and finished products. A risk assessment of the current viral control strategy thus become of paramount importance, mostly through the evaluation of the potential of the cell lines to replicate coronavirus and the effectiveness of the viral clearance and inactivation steps currently in place.

A further Guidance for Industry(2) was released in January 2021 to address the Covid19 contamination risks to which cell and gene therapy products can exposed: consistent with the recommendations and requirements reported in the first Guidance, FDA asks for a full assessment of the screening measures applied to cell and tissue donor, biological materials and manufacturing processes to evaluate the risk for viral contamination and the potential impact on patients safety.

Covid19 impact on drug safety and quality.

In the perspective of a general assessment of the risk of Covid19 contamination and the potential impact on manufacturing environments, processes and finished products, drug manufacturers are requested to evaluate what could be the actual impact in case Covid19 contaminates the materials, components and drug products. The risk assessment must therefore be based on the current available information about Covid19 transmission and resistance, in combination with the properties and types of the drug products in scope.

Drug supply continuity.

Finally, manufacturers are requested to evaluate and define, in light of the hygiene and control measures in place aimed to contain as much as possible the spread of Covid19 among personnel, dedicated strategies to ensure the required supply continuity of their drug products.

In the light of the quality and risk aspects highlighted in the FDA Guidance for Industry, it becomes evident once again how it is of paramount importance for any pharmaceutical manufacturer to have a strong and robust quality risk management in place and to deeply master risk management principles and tools to face not only the challenges posed by the contingent Covid19 pandemic, but also from any quality aspect inherent to their pharmaceutical manufacturing.


[1]U.S. FDA Guidance for Industry – “GMP Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing”, June 2020 – download it here.

[2]U.S. FDA Guidance for Industry “Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency”, January 2021 – download it here

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