Microbiology FDA 483 (Biocon Sdn.): Failure to have written procedures for connective and preventative actions during loss or reversals of different pressure in classified aseptic areas
Observation
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Biocon Sdn. Bhd.
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Specifically, your firm has no written procedures on what corrective actions are to be performed when aseptic areas have a loss in differential pressure to return to a state of cleanliness that is suitable for resumption of aseptic operations. Your SOP entitled, “ENVIRONMENTAL MONITORING ON TEMPERATURE, RELATIVE HUMIDITY AND ROOM AIR PRESSURE DIFFERENTIAL IN CLEANROOM AREA”, Document No. BWPDP/SOP/018, Version 008, Effective 12/13/2022 is inadequate because it does not address how to mitigate nonviable / viable contamination after a loss / reversal in differential pressure that exceed your established limit of *** For example,
- Deviation PRID #3034- Loss of differential pressure for 47 minutes in the aseptic filling area through during production of *** Batch *** on through
- Deviations PR #1322- Loss of differential pressure for 30 minutes in the aseptic filling area during production of *** Batch *** on 06/25/2020.
- Deviation #78215- Loss of differential pressure for *** in the aseptic filling area during *** Vial Batch *** on 07/20/2022.
Furthermore, your study conducted to establish differential pressure excursion specification limit of NMT than *** is inadequate because it was conducted at rest and does not demonstrate that classified aseptic areas will be in state of control during a loss/reversal of differential pressure during aseptic activities.
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