In response to:
Dear Joanne,
Nice to meet you! I have found a topic on the Elsmar forum in which you were involved, that is the reason why I contact you. (I also just tried to connect through Skype)
https://elsmar.com/elsmarqualityforum/threads/gcc-submissions-average-review-time-for-sgh-qualification-files.64997/#post-624654
From this topic I understand that you have been involved in a GHC audit. Can you share some of your experience with us? We will have the same audit in a few weeks, so any information will be helpful. We have questions like: will it be a difficult audit, what will be the main focus, is there anything special we should know or prepare? Thank you very much for any information you can provide!
Dear C,
With regard to
'difficult' audits, the only audits I have ever found 'difficult' are those where the auditors are incompetent.
If this is what you are implying, the answer is no, it will not be difficult. It will be straight forward.
The main focus is compliance and the state of the manufacturing facility.
If you are the Submitter, you should be able to get an audit checklist from the Director General.
If you're not the Submitter then ask your Submitter if they can get you a checklist.
I don't have a copy of the checklist to reference but from memory, when we received it, we had a meeting to ensure we covered everything listed.
The checklist included such things as 'no peeling paintwork' etc.
We did a little bit of touching up here and there on site. But I think the peeling paintwork was in reference to clean room environments. So no need to redecorate the factory. Although that's what we thought we had to do when we got the checklist!
Ensure your housekeeping is in order, both inside and outside.
The audit duration was a lot shorter than anticipated. It was handled by a new Quality Manager who had no prior experience of handling this/FDA/NB etc audits.
If you do have a copy of this checklist ,can you post it here please for everyone to see and I will probably be able to give you more information?
Please let me know if you have any more questions and I will be more than happy to answer.
