How you will classify the recall

Reference no: EM133619611

Problem

William Osler Hospital, Toronto, contacted your Quality department and reported that visible particles were observed in several vials of Tannerarmapharma Injection 6 mg/ml, Lot 23-2587. At the time of the complaint, these samples were 10 months old. An investigation was conducted on stability samples from this lot using the samples designated for the 12-month time point. Full product testing was performed on the samples and they failed the test for particulate matter. You have not been able to identify the particles this point in time.

As QA manager, how would you proceed?

Be detailed in your answer. Include, firstly, which process you will follow to conduct this recall. Where can details of this process (or the requirements) be found?

Indicate the steps you will follow...

How you will classify this recall. Who you will contact, when you will contact them, how you will contact them, and what information you will provide at each stage? Follow the process from making the decision to recall, through to the closure of the recall.

Reference no: EM133619611

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