WHO facility audit - APIs Contribution from Arun David written on 4/6/2012 at 07:57
Our new facility is to be audited by the WHO in support of a marketing application for tablts. I need some information about this audit from those who have experienced such a situation. How will the WHO facility audit be simillar to the US FDA and EU audits? When and how will the audit report/findings be given to the facility for response? Is there any format like 483 etc for WHO? Any specific/unique issues to be taken care of? Please advise. Thanks Answers to this contribution:
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19-20 June 2013 