GCC Submissions - Average review time for SGH qualification files

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J0anne

J0anne

Joanne
#3
#3
Thanks Marc.

GCC - Gulf Co-operation Council - includes six GCC member states: Bahrain, Kuwait, Oman, Qatar, Saudi and the UAE (United Arab Emirates).

I believe Yemen is also a member, although Yemen wasn't included in this particular submission.

SGH - This is a reference for the Tender and as soon as I've worked it out I'll get back to you. :agree1:
 
J0anne

J0anne

Joanne
#4
#4
I've managed to find out the following.

The qualification file was submitted to the authorities during July.
Most manufacturers files are rejected, but mine wasn't.
There have been no questions asked on the content of the submission, so I'm guessing there aren't any.
There has been a request for an on site audit four months after the submission date. I don't know if the authorities are auditing, or the customer.

Once I find out anymore I'll update this post.
 
Marc

Marc

Fully vaccinated are you?
Leader
#5
#5
We all appreciate the update, JOanne. It appears you're an "advanced explorer" in this since no one has commented.
 
J0anne

J0anne

Joanne
#7
#7
FYI It's been a while ...the GCC auditors came to inspect the site and a few years later the manufacturer is expanding yet again!

A valuable tool for anyone who wants to enter the Gulf States with a single application.
 
J0anne

J0anne

Joanne
#8
#8
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.
 
M

MedicalDevice123

Regulatory affairs specialist
#9
#9
Hi Joanne,

Thank you very much for your response! In another Elsmar topic, I have found the checklist attached, and we received the same from our local authorized representative, so it is still used. From your answer I assume the main focus during the audit is this checklist, so we will use that for preparation. Any additional experience you can remember is welcome! Thank you again for your response.
 

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