Media fill test assures the sterility of the sterile manufacturing process. When any media fill test fails, it shows the contamination in the manufacturing system. This failure must be investigated.
All major regulatory agencies state for media fill test failure investigation but any of them does not have the full procedure of the investigation. Only PDA (Parenteral Drug Association) suggests that media fill test can be investigated in three phases.
A. Product and Quality Control
B. Risk Assessment
C. QA Assessment
A. Product and Quality Control:
First of all, Investigation is done on laboratory level. Laboratory errors and mistakes are investigated. Sterility of the media used in the media fill test should be checked. If nothing is found in phase A the investigation should proceed for phase B.
B. Risk Assessment:
Identification of all microorganisms present in contaminated vials up to the species level shall help to investigate the cause of the contamination. All contaminated vials should be checked for breakage and any crack.
Try to find out the possible source of contamination matching with the environmental isolates. Review the history of media fill for the product last time for contamination. Review the batch filled with the same filling line since last media fill test. List all possible root causes of failure. List the batches to be held, those are suspicious and require re-analysis.
Try to find out the possible source of contamination matching with the environmental isolates. Review the history of media fill for the product last time for contamination. Review the batch filled with the same filling line since last media fill test. List all possible root causes of failure. List the batches to be held, those are suspicious and require re-analysis.
Area cleaning and sanitation record should be reviewed for proper cleaning for the day of media fill validation run. Area qualification and maintenance documents can be reviewed to get the idea for a possible root cause.
C. QA Assessment:
If the root cause of the failure is determined then the cause is considered as assignable cause and the media fill testis repeated with the corrective and preventive actions.
But if the cause is not determined then the cause is considered as non-assignable cause and the filling process is considered as a new manufacturing system. Three consecutive successful media fill runs are required to the manufacturing process again.
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