Temporary guidance for BCN-DE1 QM Milch Certification

21 December 2016

At this moment GMP+ International is receiving a lot of questions how the Country Note BCN-DE1 QM-Milch can quickly but justified be added to the scope of certification of GMP+ participants without auditing GMP+ participants on site. In this memo guidance is given for this certification.

Background

A GMP+ certified company (GMP+ Participant) can only demonstrate that he meets the QM-Milch requirements via certification for the above mentioned country note. The special scope will be registered in the GMP+ Company database and is the ultimate proof that this GMP+ company is qualified as QM-Milch approved supplier

Current situation

Usually the Country Note BCN-DE1 is added to the scope of certification of the GMP+ Participant during the annual GMP+ audit. But because the interest of becoming GMP+ certified for the Country Note BCN-DE1 QM Milch is growing rapidly it is a this moment not desirable to wait on the annual GMP+ audit. The GMP+ market and GMP+ accepted Certification Bodies requested GMP+ International to provide a (temporary) solution.

Solution

Desk assessment

Looking at the requirements of the Country Note BCN-DE1 QM-Milch and the fact that the GMP+ Participant is already known to the Certification Body, GMP+ International does allow the Certification Bodies to add the Country Note BCN-DE1 QM-Milch to the scope of certification after a positive documentation/desk assessment.

This is only applicable if the Country Note BCN-DE1 QM-Milch is added to the existing scope of certification and the annual GMP+ audit has already been conducted.

Assessment of head office & certification of all relevant locations

The hereabove explained situation can also be applicable for a GMP+ certified head office and GMP+ Participants resorting under this head office (the sub locations). For example if the head office manages the monitoring program for all locations. Based on a positive documentation/desk assessment the Country Note BCN-DE1 QM Milch can be added to the scope of certification of the GMP+ certified head office and GMP+ Participants resorting under this head office (the sublocations). In this situation audit time reduction can be applicable, to be handle between the Certification Body and GMP+ Participant(s).

This is only applicable if the Country Note BCN-DE1 QM-Milch is added to the existing scope of GMP+ certification and the annual audit has already been conducted at the GMP+ certified head office.

Deadline for certification

Currently we are confronted with many questions from companies and certification bodies regarding the deadline for certification of 01-01-2017 communicated in various newsletters (for example this newsletter). Many companies want to become certified at this moment, but run into limited availability of certification bodies to audit them on short notice.

We would like to inform you that we will keep the temporary list on our website a little longer, providing you the option to finalize the certification of these companies at 31 March 2017 latest. Please note that afterwards the temporary list will be removed and all companies that want to be accepted by QM-Milch need to be certified. 

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