GMP+ requires that Schouten Certiﬁcation, as Certiﬁcation Body, assesses your gatekeeper ﬁles. We are required to base the audit duration on the number of gatekeeper ﬁles. We therefore need to check whether our information about the number of gatekeeper ﬁles you manage is correct.
You must report certain gatekeeper ﬁles (in Dutch: poortwachterdossiers) via the GMP+ website. There is no obligation to report the other gatekeeper ﬁles to GMP+. This is stated in Technical Specification 1.2 – Purchase.
This message is to inform you about the number of gatekeeper files known to us and how this affects the total audit time.
The audit time for gatekeeper files in purchase of additivites, food stuffs, pharmaceutical products (4.3.3), former foodstuffs (4.3.4) and processed feed materials is 1 hour per file, the audit time for files in the other categories is 0.5 hours per file. The additional time will be spread over the certification cycle of 3 years.
Please note: please provide the total number of gatekeeper files (poortwachterdossiers) currently in use under your GMP+ recognition
Wij staan klaar om met u te bespreken wat u wilt bereiken. Tijdens de aanvraag inventariseren we uw bedrijfsprocessen en interne organisatie en plannen we een audit op maat.