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A business has numerous media fill failures. They conducted their media fills making use of TSB (tryptic soy broth) ready by filtration by way of a 0.2 micron sterilizing filter. Investigation didn't present any clear brings about. What could possibly be the supply of contamination?All reasonable precautions shall be taken to make certain that gen
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As an example, although the CPG will not specifically mention concurrent validation for an API In a nutshell provide, the Agency would think about the use of concurrent validation when it's important to handle a real limited-source circumstance, and If your concurrent validation analyze conforms for the situations recognized inside the CPG (see par
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