COMMENT
CBER issued to Sanofi Pasteur an eleven page, 32 Observation Form FDA 483 following an audit of their Toronto, Canada facilities. The dates of inspection encompassed the time frame of April 10 – 25, 2012. CBER previously published the Warning Letter regarding this subject which was initially noted within this Blog earlier in the week. The most significant Observation (#1) suggests that because the last successful Sterility Test Validation was performed in 2001, it remains possible that all lots produced since then may have been contaminated with mold since the re-validation test failed to detect yeast and mold, if present, in sterility test samples.
1. Sterility for all BCG lots manufactured in Building -(b)(4)- since the firm’s last successful Sterility Test Validation in 2001 cannot be assured in that:
A. Protocol B006293 was conducted as a re-validation of the firm’s sterility test method for BCG. The failure of the re-validation test resulted in failure of the method to detect yeast and mold in the bacteriostasis/fungistasis testing and questions the ability of the firm’s current test method to detect yeast and mold, if present, in sterility test samples. Protocol B006293, was conducted to validate the sterility test method of BCG using the -(b)(4)- ——–(b)(4)————-.
COMMENT
The question that this Observation raises is how frequently a Company should be repeating a bacteriostasis/fungistasis test of a product. Often one hears that it should be repeated whenever a significant change is made. Others may argue that it should be performed on an annual basis. In this situation a number of years passed, and when repeated, the test failed. Does anyone have any thoughts or can relate their individual situations?
The entire Form FDA 483 may be observed at:
http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm310376.htm
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