Oral Solid Dose – Quality Risk Management Considerations

Hello good people of the world! Today’s post is the second in the series covering the commissioning, qualification, and validation of facilities, systems, and equipment involved in the manufacture of oral solid dose (OSD) products. This post covers quality risk management.

Quality Risk Management is performed per the principles outlined in ICH Q9. The management process may then be divided up into six (6) steps:

  1. Determine risk areas. These are typically safety, product quality, schedule, cost, etc.
  2. Identify the risks for each area defined in step 1. For example, microbiological contamination may be a risk to product quality, APIs may be a risk to personnel safety.
  3. Identify the failure modes which contribute to the risks identified in step 2. For example, pests contribute to microbiological contamination risk, and HVAC failure could be a vector by which personnel are exposed to an API.
  4. Analyze failure modes and identify mitigations. In our examples procedures around pest control and qualification of HVAC systems could be mitigation to the failure modes identified.
  5. Implement monitoring and CAPA (corrective and preventative action) processes.
  6. Apply a continuous improvement plan to periodically review risks, risk assessments, and mitigation.

There are many tools which may be used to document the process, such as: FMEA, HAZOP, PHA, etc.

How do you execute your quality risk management process?

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