In May 2017, the FDA advised on Contamination Risk for Burkholderia cepacia concerning water-based drug products to remind drug manufacturers of non-sterile products to establish suitable methods to prevent objectionable microorganisms contamination.
Microorganisms of concern are directly involved in a number of recalls with the fact that an exposure to these microorganisms can increase the risk of illness or infection.
Some regulations have defined key requests for microorganism of concern, including the need to perform risk assessments for these species in the product and raw materials. They also request to develop sampling procedures and acceptance criteria.
Why to determine if an isolated microorganism is of concern?
Who is responsible to define if a microorganism is of concern?
How to determine if an isolated microorganism is of concern?
One concrete exercise/example of risk assessment (Burkholderia cepacia complex for non-sterile products).
Are microorganisms of concern limited to non-sterile products?