Re launch Voluntary add-on Unannounced Surveillance Audit

14 June 2018

The Voluntary add-on unannounced surveillance audit is re-installed in the GMP+ FC scheme as of June 4th 2018, by an Executive decree article 11.1 GMP+ A1 General Regulation.

As requested from our members, a temporary reinstallation of the voluntary add-on unannounced surveillance audit has been done. As a result of the relaunch, our certified companies no longer have to unnecessarily wait until the next official unannounced surveillance audit. GMP+ International offers you the opportunity to generate  business with a variety of accepted partners. Therefore voluntary add-on unannounced surveillance audit offers companies more flexibility to comply with the requirements as implemented in the GMP+ FC scheme.

The voluntary add-on unannounced surveillance audit can be one extra audit during the certification cycle.

 

The following conditions will apply:

 

  1. The temporary reinstallation of the voluntary add-on unannounced surveillance audit is applicable only for GMP+ companies certified in the production scopes.
  1. The voluntary add-on unannounced surveillance audit can be used until November 15th, 2019.
  1. You may request one voluntary add-on unannounced surveillance audit per certification cycle.
  1. The voluntary add-on unannounced surveillance audit cannot be used to expand your GMP+ certificate with an additional GMP+ scope.
    Once agreed between the GMP+ certified company and the involved Certification Body, the voluntary add-on unannounced surveillance audit must be secured in the GMP+ certification agreement and it becomes compulsory.
  1. Examples of postponing the voluntary add-on unannounced surveillance audit are:
    • The Certification Body cannot visit the site of the participant due to extreme weather conditions.
    • The location of the participant is temporarily closed or the location is not conducting GMP+ activities (seasonal work).
  1. Prior notice to perform the voluntary add-on unannounced surveillance audit from the Certification Body to the GMP+ certified company is NOT allowed.
  1. Topics to be audited must be based on a risk assessment of the Certification Body, and must at least cover the production facility.

At GMP+ International we continue to learn from your feedback and offer solutions to changes in market demands. If you have any questions concerning this message, please contact your GMP+ representative or get in touch with GMP+ International: www.gmpplus.org or call +31 (0)70 307 4120.

Sign up for the GMP+ International newsletter

Stay up to date with the latest news