GMP Checklist for Distribution Activities? ISO 13485

[sreenu927]

Hi All..

We are manufacturing medical devices. the site is ISO 13485 certified. We also have our distribution center at the same site location, but not ISO 13485 certified. The scope doesn't include distribution.
But, now, we would like to extend our ISO 13485 certificate scope to Distribution center and also looking at the distribution center to be GMP compliant (21 CFR 820 compliance).

1. Hence, could you pleae advise on the requirements for the distribution center to be ISO 13485 certified and also cGMP compliant.
Is there anyGMP checklist to work on for the distribution center?

The activities of the distribution center include, receiving the imported devices, storing, packing, shipping, and supplying.

2. Likewise, is there any GMP checklist for repair center aswell?

Any advise is highly appreciated.

Thanks,
Sreenu

 

[Denis]

Re: GMP Checklist for Distribution Activities??

A brief outline would be

Traceability
Pest control, with map of locations
Documentation
Work instructions
Training
Control of short shelf life products ( to identify and action any stock which is close to, or exceeded its shelf life)
Control of product samples (if applicable)

Not meant to fulfil all requirements, but a reasonable starting place.