Quality risk management is an essential tool for qualification of aseptic processes. It is not just a tool for CGMP compliance;
it offers real benefits to the validation process by identifying risks and ensuring that critical risks are controlled. By
focusing managing risks to the patient, pharmaceutical manufacturers can ensure that the right resources are applied at the
right place at the right time—improving patient safety while eliminating unnecessary validation efforts.
Ed White is a QA validation specialist at Baxter Healthcare Corporation, 1700 Rancho Conejo Blvd., Thousand Oaks, CA, 805.375.6779,
. This article was first published in The Journal of Validation Technology, Vol. 15, Num. 2, Spring 2009.
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