Members Questions – Aseptic Manufacturing

Following our meeting in Dublin on the 7th-8th November, a number of questions were raised regarding site performance aseptic manufacturing:

  • Do you record the processing of all batches using video and if so what do you use the videos for- deviation investigation/training/security??. How long to you retain the video footage for?
  • Do you record media fills only and if so what are the videos used for? Investigation of media fill failures for example.
  • How long you retain the video footage for?
  • Have any regulatory agencies requested videoing of either media fills or routine aseptic manufacture?
  • For other manufacturing operations.
  • Do you use videos to record processing for any other dosage forms ( i.e. tablets/capsules etc) and if so for what purpose and how long do you retain the video.

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