Some of the changes are:
C1
The approval requirements for auditors / inspectors / technical reviewers have been changed. These apply to all new approvals of auditors / inspectors / technical reviewers. As from today it's also possible to count as well audits for equivalent schemes as audit experience, so that auditors for certain GMP+ standards / scopes can comply more easily with the minimum number of audits.
C3/C6
The audit times for the new GMP+ B2(2010) have been added. The audit times have also been changed for GMP+ B1 - scope: production of feed materials.
Some equivalent schemes have also been included on the basis of which audit time reduction may be applied during an audit for GMP+ certification. The notes include when audit time reduction may be applied.
The multi-site requirements have been modified in Appendix 4, sub 1.
For all the changes which have been made, please refer to the specified GMP+ C documents (link to C1, C3 and C6). The changes are marked in grey.
