FDA advises API makers on COVID-19 safe practices

On June 19, the US Food and Drug Administration (FDA) released a guidance document for the pharmaceutical industry, “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing​.” The advisory, non-binding document is intended to offer information to manufacturers of active pharmaceutical ingredients (APIs), drugs, biologics and other items in the face of the pandemic.

The document is being issued jointly by the FDA, Centers for Drug Evaluation and Research (CDER), Biologics Evaluation and Research (CBER) and Veterinary Medicine (CVM).

Manufacturing controls

The document includes a range of suggestions to keep APIs and other items free from contamination by the COVID-19 virus. These include monitoring employees for signs and symptoms of the virus, and keeping such sick employees from entering production areas.

Additionally, the FDA guidance suggests promoting good sanitation and health habits among employees, especially those who come in contact with products and production areas. Management also should make sure stringent cleaning and sanitation practices are adhered to for production and nonproduction areas alike.

The document also recommends use of personal protective equipment (PPE) such as masks. If supplies of single-use masks and other gear is low, the document recommends prioritizing use of such equipment for sterile manufacturing operations and personnel.

Keeping drugs safe

While the FDA has neither received nor shared word of any APIs or drugs becoming contaminated by the virus, the agency is offering guidance on how to keep products, processes and equipment safe, to prevent such contamination from happening in the future. Future risk assessments should take in the possibility that such contamination could occur, however unlikely, in order to preserve the integrity of product and protect consumers.

The agency recommends manufacturers of APIs and drug products ensure risk assessments and other evaluations are approved by the quality unit and documented in its quality management system, to ensure compliance with CGMP requirements. Also, the FDA suggests API makers put in place procedures to ensure evaluations used to determine if API quality or safety have been effective are proper.

Maintaining the supply

The agency recommends sending COVID-19-affected employees home, as well as notifying other staff that may have been exposed or infected. Additionally, the FDA recommends consideration of social distancing procedures for employees in production, laboratories and other areas to minimize exposure.

The guidance document suggests if a company is diligent in preventing adverse effects on the safety and quality of its products, the likelihood of drug supply interruption is reduced. Therefore, adherence to staff, facility and production preventive and safety measures is recommended.