With effect from 1 January 2021, GMP+ certified companies will be responsible for informing the Certification Body if they are using a gatekeeper protocol. GMP+ notification forms can be used for this purpose.
An important condition in the new GMP+BA10 Minimum Requirements for Purchasing published earlier this year is that as a GMP+ certified company, you must report to GMP+ International if you are using a gatekeeper protocol. Until now, GMP+ has informed the Certification Body. This is going to change.
From 1 January 2021, if you use a gatekeeper protocol you must report this to your Certification Body yourself. Make arrangements with your Certification Body about how they want to be informed about this.
You can easily use the GMP+ notification forms for this purpose. An extra field has been added to the form. If you enter the e-mail address of the Certification Body here, the Certification Body automatically receives a copy of the notification form.
The Certification Body may need additional information, for example to prepare the audit. You should make arrangements about this with the Certification Body.
To be clear: there is no change to the reporting obligation. After 1 January 2021, GMP+ certified companies must inform both GMP+ International and their Certification Body if they use a gatekeeper protocol.
The GMP+ reporting forms can be found here.
The recordings of our recent webinars on the various gatekeeper protocols can be found here.
The FAQ document can be found here.