Can't help but wonder how many people here also find this surprising, and how many find it sadly predictable.
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Julie Omohundro RAC
Durham NC
United States
Original Message:
Sent: 03-24-2014 01:37
From: Robert Falconer
Subject: Regulatory Assessment in Change Control -
In my own recent quality system audits of Rx drug manufacturing sites - in both US and non-US sites supplying products to highly regulated markets - it is surprising how often a firm's change control SOPs are not very specific as to how/when RA dept assessments must be done.