Bioequivalence and Bioavailability Forum

Hi all,

I have been reading the recent warning letter to Hospira.

There are some findings relating to sterility and FDA wrote:
"Please provide a current global corrective action plan for your facilities (US and foreign sites). Include a comprehensive training module on aseptic process techniques for all employees involved in aseptic process operations and how you plan to measure the effectiveness of any training being provided."

Since I am by no means knowledgeable with cGMP (the walnut is only big enough for a wee bit of GCP and GLP) I am curious to learn how effectiveness of the traning could be evaluated in this case. As I read the letter, it has not been proven that any product was actually contaminated so I guess a measure of effectiveness of training is not a decrease in contamination rate. Would effectiveness of training in this regard then simply be to perform training and afterwards ask the trainees questions relating to the SOP and training content and predefine what a success rate is (like X correct answers out of Y questions or something)? Or would it also imply to somehow measure if they are applying the training correctly in practice? The latter would make sense to me. I assume that might somehow involve direct oversight of true production runs from QA staff?? Am I going wildly astray?

Looking forward to learning a tiny bit of cGMP from the experts here.