InsideFivePharma / Supplier Auditing / The Agenda / Five from FivePharma

This is your chance to set the tone and lay out your intentions to the supplier.?What are the top 5 things you should ensure and dealt with on the agenda??There is a lot of stuff to cover but we recommend these five things should never be forgotten:

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1?????????????????When will the audit happen and what time will it start and end, oh and what time zone applies, especially important if it is a remote audit.

2?????????????????Who will be on the auditor’s team and what are their roles, and very importantly who will be the Lead Auditor.

3?????????????????What will be the Reference Document that the audit will be conducted against, for example EU GMP Volume 4 Part 1 (if it’s a medicinal product for sale in EU), for example ISO 13485 (if it’s a medical device) and so on.

4?????????????????What topics will be covered and approximately when during the audit.?Please give best guesses.?Remember don’t be overly ambitious with the scope, you have limited time, make sure you allocate enough time to the important topics.

5?????????????????Finally when will the Report be generated and sent to the supplier.?Remember, do it as fast as you can, otherwise it may never get sent!