Line clearance - Routine components in the prep room for universal use

D

Denis

#1
Hi, I work for a pharmaceutical supplier who operate to cGMP and try to adopt the Orange Guide guidelines.

We have a preparation are prior to final assemble, in this area we have various common components. Theses common components have all been booked in and inspected, then given an internal identification number. This number is then used to compile the bill of materials for manufacture.

Heres the issue.

Our production guys would like us to hold certain routine components in the prep room for universal use. I have a number of issues with this.

We cannot now provide full traceability for any given product, due to some component parts being made from a mixture of individual batch numbers.

It gets worse, the one part, it's a plastic bag - which is used to seal the product - the product is then irradiated - has a poor incoming control in terms of bioburden and bag thickness. Thickness affects the subsequent sealing process, if the seal fails the product sterility is breached.

Does anyone have any comments or similar experiences.

Regards

Denis
 
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Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#2
Denis said:
Hi, I work for a pharmaceutical supplier who operate to cGMP and try to adopt the Orange Guide guidelines.

We have a preparation are prior to final assemble, in this area we have various common components. Theses common components have all been booked in and inspected, then given an internal identification number. This number is then used to compile the bill of materials for manufacture.

Heres the issue.

Our production guys would like us to hold certain routine components in the prep room for universal use. I have a number of issues with this.

We cannot now provide full traceability for any given product, due to some component parts being made from a mixture of individual batch numbers.

It gets worse, the one part, it's a plastic bag - which is used to seal the product - the product is then irradiated - has a poor incoming control in terms of bioburden and bag thickness. Thickness affects the subsequent sealing process, if the seal fails the product sterility is breached.

Does anyone have any comments or similar experiences.

Regards

Denis
Why not just segregate the component parts according to the "internal identification number"?
 
D

Denis

#3
Hi
Well that has been suggested but we need to identify for each batch record document the coponent parts (identified by the Goods Recieved Number). If we can to a different product - where there is no use for these raw material parts we should return the goods to the raw materials warehouse.
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#4
Denis said:
Hi
Well that has been suggested but we need to identify for each batch record document the coponent parts (identified by the Goods Recieved Number). If we can to a different product - where there is no use for these raw material parts we should return the goods to the raw materials warehouse.
Why? Because you say so or is there a legitimate risk of contamination or mix-up. What is the risk? Talk money. It's the only thing management understands. What is the % risk versus the loss.
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#6
Denis said:
We operate to cGMP, GMP require line clearance. No money issue here.
  • What do you save by breaking the regulations?
  • What will it cost you when you get caught?
  • What is the cost of a recall?
  • What is the cost of the bad publicity associated with a recall?
 
L

Laurie Anderson

#7
No Way

Dennis,

Stick to your guns. The risks associated with this practice are too great !
Both from a Traceability perspective and also a Contamination perspective.

Right on Al

Laurie A
 
D

Denis

#9
I'm going to take the moral high ground here, or at least it will come over that way.

I believe we have a duty to operate and implement certain standards, GMP is one of them.
If we say we work to GMP(or any other standard) then we have a duty to demonstrate this to our customers.

Otherwise we are saying one thing and doing something completely different.
 
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