Visual inspection qualifications

Production
1

I have found market complaint regarding to visual inspection like broken vial seal rejection
I have prepare CAPA for visual inspection qualifications previous SOP is qualifications period is 1 year and as per CAPA 15 days what is a proecedure for change visual Qualifications SOP?

2

Before deciding CAPA actions your QA must have conducted thorough investigation of the referred market complaint and must have identified root cause(s) of this complaint. However, it is not understood that why have you reduced frequency of re-qualification of visual inspectors from 1 year to 15 days which is very short. Was this complaint an isolated case or repeatitive complaints received for many times?

Please consider the following steps for implementation of this change,

  • Based on the identified root cause(s) of this complaint please decide CAPA actions.
  • CAPA actions should be based on Risk assessment.
  • Raise Change control proposal to revise relevant SOP of Qualification of visual inspector and other changes if any.
  • Change proposal should be reviewed and approved by QA if found appropriate.
  • Implement the change(s) as identified in the CAPA.This should include revising current SOP of visual inspection and qualification of visual inspectors, Retraining of visual inspectors, re-qualification of inspectors. Review the visual defects library of injection products (Rejected vials due to visual defects) and update if necessary. This is required for training purpose.
  • Assess effectiveness of CAPA implementation.
  • Review market complaints of injection products of similar nature (To assess effectiveness of CAPA implementation)