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Coronavirus impacting GMP+ audits for GMP+ Certified Companies
03 marca 2020
The coronavirus has an impact on audits performed by your Certification Body. They will be confronted with difficulties for planning and conducting your GMP+ audits.
This means that the audit frequency can be affected and not comply with the GMP+ requirements.
Therefore, the coronavirus is designated as an extraordinary event by GMP+ International. The below requirements give CB’s the possibility to postpone audits for a maximum of six months as of February 27th, 2020.
- When the surveillance audit cannot be performed within the total period of 6 months, the GMP+ certificate must be suspended by the CB. Article 2.11 of the GMP+ C6 is applicable.
- When the re-certification audit cannot be performed the validity of the GMP+ certificate can be extended for a maximum period of 6 months. In order to do this the CB must perform, as stated in article 2.5.a. of the GMP+ C6, an assessment of the quality documentation to collect enough evidence that the Feed Safety Management System is effective.
The re-certification audit on site must be carried out within this permissible extended period. When the CB has performed the re-certification audit on site during the permissible extended period the starting date of the new certificate must be the first date after the original expiration date of the previous certificate.
If the re-certification audit on site including certification decision cannot be performed in the permissible extended period, the GMP+ certificate cannot be extended.
GMP+ International will follow the (travel) advice of the Dutch Ministry of Foreign Affairs (only available in Dutch) for quarantine regions. This means that regions indicated in orange and/or red have a negative travel advice which can influence your audit frequency.
If you have any questions, please don’t hesitate to contact your Certification Body.