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

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

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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.

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Denis said:

We operate to cGMP, GMP require line clearance. No money issue here.

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