Quality Risk Management in Annex 1; 6.1

Quality Risk Management in Annex 1; 6.1

The use of Quality Risk Management (QRM) principles and risk-based approaches are prominent expectations throughout the Annex 1 draft. Risk-based approaches are mentioned 43 times in the draft reinforcing the importance of using Risk Based approaches in all aspects of sterile product manufacturing. In part 2 of our five-part series, we highlight requirements related to Quality Risk Management that are specifically mentioned in Annex 1, section 6.1 around utility systems:

“The nature and extent of controls applied to utility systems should be commensurate with the risk to product quality associated with the utility. The impact should be determined via a risk assessment documented as part of the CCS.”

This applies to critical product contact utilities such as:

  • purified water
  • WFE
  • clean steam
  • any other gases that have direct product contact

It is necessary to conduct a scientific evaluation of the characteristics and functionality of each point; the goal is to define QC sampling points and Points of Use. It is important to make sure to consider any unused points and that an evaluation of each valve regarding slope, positioning and disinfection is done. Other items to consider are how the piping is managed: flushing, disinfecting, etc.

This will also help determine the appropriate sampling handling technique and what are the appropriate sample containers to develop a sampling plan.

Benefits of using QRM for Utilities Monitoring

A sampling program should include:

  • All points of use, at a specified interval, to ensure that representative water samples are obtained for analysis on a regular basis.
  • The RA helps us defines sampling points by different criticality, e.g.: WFI for RM versus WFI for cleaning.
  • Establish different frequencies based on the risk.
  • This helps to reduce time and material to do the testing.
  • Help ensure sampling is done at areas that are at the greatest risk to products.

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