Production processes not all in the same building

Hi all!

I need some input regarding production processes not in one roof.

We have 4 plants in one area. The Plant 4 is fully dedicated to primary packaging but not all processes are in Plant 4. The cutting, offset printing and diecutting are done in Plant 1 which is adjacent to Plant 4 while the RM Warehouse and Sheeting are in Plant 2 which is across Plant 4. We have procedures for the transfer of products from one plant to another.

Will this be an issue for BRC/IOP certification? We are getting ready for the pre-assessment on the 4th week of October.

Any help will be appreciated.

Best regards,

I would think that you would have to show that you took this into consideration in the risk assessment.

Gail

What are your concerns MCIAN?

Regards,
Simon

Gail, thanks for the input.

Simon, my concern is that the Plant 1, 2 & 3 facilities are generally for secondary packaging  so what we did was to isolate the mentioned processes related to primary packaging and GMP procedures are implemented. For one thing, the mentioned processes also do secondary packaging so the GMP controls are not so tight compared to the Plant 4. 

Any situation like this in other companies?

Regards.

I cannot visualize the plants without more detail on buildings, layout, policies and procedures.  You can isolate part of a production unit and make that part high hygiene and the rest lower risk, but the decision has to based on risk assessment and it must work effectively and in practice this can be very difficult.

You say printing of primary packaging is done in unit 2.  How do you risk assess and give justification to say this area is not high hygiene, same for die cutting etc. In my experience they would be subject to high level procedures in primary packaging manufacture. 

Regards,

Simon

Hi Simon,

Great input. Actually, what we did was really to isolate those areas that are part of the primary packaging processes and implemented hygiene procedures in them. The critical part here is during change over from secondary packaging items to primary packaging, stringent cleaning of the machine and environment is instituted as a requirement, as a result of the risk assessment. Will this be enough?

Warm regards,

Why what kind of mess does the secondary packaging cause?