FDA Publishes New Temporary Guidance on “Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency”

Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency

The 9 page temporary guideline emphasizes to evaluate/monitor the following in the COVID-19 public emergency to ensure drug quality.

  1. Impact of manufacturing/testing deviations in the final product (e,g: incomplete or delayed testing and batch release)
  2. Importance of ensuring the supply chain credibility of starting materials (e.g: economically motivated adulteration, broken tamper-evident seals, unexpected changes to packaging or labeling etc.)
  3. Alternatives for onsite supplier audit (e.g., a remote supplier audit, reassessment or revision of a quality agreement etc.)
  4. Facility and equipment changes/delays in maintenance (e.g., the water purification system was not operated according to established procedures, putting it at greater risk of objectionable microbiological contamination, delay in preventive maintenance or calibration activities  etc.)

Guidance signifies the importance of developing a comprehensive resumption plan using risk management approach that is specific to the operations and organizational needs. The plan shall cover Filed alert/Recall requirements, notifying FDA of a permanent discontinuance in the manufacture of certain products or an interruption in the manufacture of certain products etc. The guidance also says “management leadership is important to successful execution of the resumption plan”.

The guideline also suggests during resumption of manufacturing activities, high priority should be given to drugs that are in shortage or at risk of shortage.