Stage 1: Site Assessment
A full review of the quality systems in place at the facility is undertaken. This is carried out via a paper/electronic audit as well as a physical audit.
The Site Assessment involves:
- Raw Material (RM) Evaluation at Each Production/Packing Site
- Raw Material Supplier Assessment Procedures
- Certificate and SOP Review for all Production/Packing/Storage Areas
Stage 2: Pre-Certification Swab/Sample Testing
During the Site Assessment Process, a number of swabs/samples are collected from various critical control points. These swabs/samples are tested at LGC to ensure that there is no indication of contamination issues with prohibited substances at the site.
Initially, a minimum of 20 swabs/samples are collected and tested. Analysis time is typically 7 - 10 working days from receipt at the lab, and results will be reported to the prospective member via a Certificate of Analysis.
Stage 3: Post-Certification Requirements
Once Stages 1 and 2 are complete, and the requirements of Informed-Choice have been met, the site will be accepted for site certification with Informed-Choice. A license agreement will be issued, which enables the new member company to use the Informed-Choice Certified Site logo in association with the certified site. The certified site will be listed on the Informed-Choice website, along with a link to the member company's website.
Post-Certification Site Visits and Testing
Once certified, the member company will be physically audited every 6 months to ensure that compliance with the Informed-Choice program is maintained. These on-site visits involve a review of procedures being followed, as well as checks to ensure that any changes in procedure have been captured and assessed. Further swabs/samples are collected during the 6-monthly audit. These are analyzed at LGC to ensure there is no indication of trace contamination with prohibited substances at the site. A minimum of 10 swabs/samples are collected during the 6-monthly site visits.
Please Note: Site certification does not mean that finished products have been tested, but rather that the site itself has been tested to show that it has appropriate controls in place to minimize cross contamination with banned substances.