August 22, 2021: Pharmaceutical Interview Questions and Answers
#InspectionOfMediaFilledUnits #InspectionofMediaFilledUnitAmberContainer #IncubationOfMediaFilledUnit #HandlingOfRejectedContainers
1. Who should perform inspection of media filled units?
Each media-filled unit should be examined for contamination by personnel with appropriate education, training, and experience in inspecting media fill units for microbiological contamination.
If QC personnel do not perform the inspection, there should be QC unit oversight throughout any such examination.
All suspect units identified during the examination should be brought to the immediate attention of the QC microbiologist.
2. How to perform inspection of media filled units of amber or other opaque containers?
To allow for visual detection of microbial growth, amber or other opaque containers should be substitute with clear containers.
3. After inspection of media filled units which containers shall be incubated and which containers shall not?
All integral units should proceed to incubation. Units found to have defects not related to integrity (e.g., cosmetic defect) should be incubated; units that lack integrity should be rejected.
4. Whether the media filled units generated during the intervention should be incubated or not?
If written procedures and batch documentation are adequate to describe an associated clearance, the intervention units removed during media fills do not need to be incubated. Where procedures lack specificity, there would be insufficient justification for exclusion of units removed during an intervention from incubation. For example, if a production procedure requires removal of 10 units after an intervention at the stoppering station infeed, batch records (i.e., for production and media fills) should clearly document conformance with this procedure. In no case should more units be removed during a media fill intervention than would be cleared during a production run.
Reference: FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice – September 2004