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U.S. FDA issues guidance for drug manufacturers during COVID-19

The U.S. Food and Drug Administration (FDA) has published guidance (dated June 19, 2020) detailing the agency’s recommendations for current good manufacturing practices (CGMP) requirements for addressing COVID-19 infection. This relates to the risks associated with employees who are engaging in drug manufacturing. The guidance was issued to help mitigate and prevent effects on drug safety and quality by employees confirmed to be either infected with COVID-19 or potentially exposed to someone with COVID-19.

According to FDA:

“As with any potential new risk, FDA expects pharmaceutical manufacturers to evaluate whether SARS-CoV-2 poses contamination risks under existing manufacturing controls that prevent drug contamination and whether the virus adversely impacts drug safety or quality should contamination occur”.

Some of the recommendations presented in the guidance document to prevent contamination of drugs from COVID-19-infected employees include cleaning and sanitizing non-production areas more frequently;. The document also discusses updating cleaning and sanitizing procedures for production areas, plus expanding existing procedures to include gloves, face masks, an gowning. There is also a comment on restricting employee access to manufacturing areas.

The document is titled ‘Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing – Guidance for Industry’.

In terms of what the document is requiring, for COVID-19 advice, the recommendation is for each manufacturer to have a COVID-19 risk assessment in place, approved by their Quality department. Within this, the risk assessment needs to state that the drug manufacturer will 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. Furthermore, personnel who either test positive for COVID-19 (regardless of whether they have symptoms) or have symptoms of COVID-19 must be excluded from drug manufacturing areas. There is also the requirement that employees practice good sanitation and health habits.

As well as people specific recommendations, the requirement is for each pharma firm to evaluate the adequacy of their 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. Manufacturers must consider the likelihood of contamination or cross-contamination to other drugs in the facility.

In addition, drug manufacturers should determine if SARS-CoV-2 could adversely affect the safety or quality of their materials, components, drug product containers and closures, in-process materials, and drugs if they were to become contaminated with the virus. The risk assessment should consider the known characteristics and studies of this family of viruses as well as the drug types and their characteristics.

These measures may need to be supported by procedures to institute more frequent cleaning, sanitization, and/or sterilization of surfaces in the production areas, particularly surfaces that are contacted frequently, such as door handles, equipment latches, bench/counter tops, and control panels. Special attention should be paid to sanitizing/sterilizing equipment and product contact surfaces.

The guidance is comprehensive and aims to address a specific risk that the novel coronavirus poses to the supply of medicines.

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