31 replies to this topic

[Loni Banaszak]

We have a meeting scheduled annually in our system, it notifies via email who's requested to be there, they accepted it updates electronically. At the meeting they sign a sheet (for back up) which is uploaded to the electronic meeting, Then all corresponding documents are attached electronically, CAPA's and NC's found during the meeting are electronically processed, but can all be traced back to that particular meeting.

[Setanta]

I would think that is more than sufficent

[3esa]

Is this a facility audit or desk audit?  To me, initially reading your post, it seems that he wants written procedure for your GMPs and pre-requisite programs.  What later posts discussed in this thread is more verification activities.

 

Did I misread your initial post?  Also, the auditor NC respose seems to reflect your auditor is looking for a procedure.

 

What I did for a similar requirement in module 11 was make sure all my pre-requisite programs had procedures to go with it, from hand washing, to throwing out the trash.

[Charles.C]

Hi loni,

 

I deduce the NCs you refer in post 19 were related to module2, not module 13

 

So presumably the GMP, Section 5,  part of module 13 was not commented on, ie OK ?

[Loni Banaszak]

I am pretty sure I did the confusion here lol, I am so lost with this........ Carry on my friends and thanks for all the help you are trying to give me!

[Loni Banaszak]

This post originally started out as a quest to get help for GMP 13.4.1.2, then I think what I had might of satisfied my auditor....... Then I found an finding from our Desk Audit referring to not having GMP is place. so that's how we are here now.

[Charles.C]

Hi Loni,

 

I'm not a SQF user but i presume that (as stated in Audit Guidance 2.1.3) for the desk audit of Code para. 2.1.3.2  you need Procedures or references to Procedures for GMP-Prerequisite Programs which will satisfy the requirements of the (relevant) sub-sections  listed in module 13, ie within 13.1 - 13.9.

 

No doubt you knew that already.

 

PS - the only relevant discrepancy i noticed between the Code/guidance was that the Code states "include or reference" while the guidance only mentions "may include". Theoretically the Code supercedes of course.

 

Of course there is a 60/40 chance i have misinterpreted the Code in which case my apologies in advance.