'Remote auditing will be part of the standard toolbox'

Certification & Compliance (C&C) makes sure GMP+ FSA and GMP+ FRA certificates are awarded in accordance with the GMP+ FC scheme. It does so by continuously monitoring the performance of Certification Bodies (CB’s). C&C is also responsible for the development and maintenance of the certification rules, harmonization of processes of CB’s and GMP+ auditors, and the examination of auditors.

2021 was the final year of C&C as a separate department. What stood out?

Roland – ‘Immediately after the first travel restrictions were put in place, we worked together with CB’s to facilitate remote auditing. In 2021, remote auditing really took center stage. We published a management decree for remote auditing that allowed Certification Bodies to conduct audits (partially) remote. Local audits were still often performed on-site, audits that would normally involve border crossing were frequently done digitally. This did really vary per region, depending on the COVID-19 rules and regulations.’

Is remote auditing the future?

Roland – ‘We believe it will be a standard part of the auditor tool box going forward. In what way, shape or form precisely, is not yet determined. We did publish a guidance for remote auditing to provide auditors with some direction. Remote auditing provided a responsible way to audit companies that otherwise couldn’t be visited.’

What did GMP+ International’s own audits look like in 2021?

Roland – ‘GMP+ International conducts so-called office audits in which we audit our CB's. We performed 35 office audits in 2021, 19 of which took place remote. We also revised our Integrity Policy. It is now more to the point and concrete. The Integrity Policy is the basis for our compliance assessments of which the office audits, parallel audits and witness audits are a part.’