Publication of new GMP+ C-documents

GMP+ International has worked closely together with the subcommittee Certification & Compliance to complete the new set of GMP+ C-documents. Subsequently the GMP+ C-documents have been approved by the International Expert Committee.

Below you will find the main changes per GMP+ C-documents.

GMP+ C6 Assessment and Certification Criteria for GMP+ Certification – Process Certification:

• The implementation of the unannounced audit for producers located in Germany and other countries in Europe (published with an executive decree March 21^st 2019).
• The country note Iberian Peninsula has been added as a normative document.

GMP+ C7 Assessment and certification/ inspection criteria for GMP+ certification/ inspection -additional/specific scopes:

• The implementation of the certification requirements for the country note Iberian Peninsula.
• Audit times for assessing:
  • Country note Iberian Peninsula.
  • GMP+ B11 Registered Laboratory.

GMP+ C10 Acceptation requirements and Procedure for Certification Bodies:

• Competences for auditors assessing GMP+ B10 Laboratory testing and GMP+ B11 Registered Laboratory have been added, related to education, knowledge and working experience.
• The table of exemptions (table 1) have been expanded with the Country Note Iberian Peninsula.

The Dutch, German and Polish versions of the new set of GMP+ C-documents will be published in a later stage.