The 2017 Standards reflect the changes in the ISO 9001:2015 and ISO/IEC 17021-1:2015 Standards.
The EXCiPACT Certification Scheme comprises the following components:
- GMP standard for excipients as an annex to ISO 9001:2015
- GDP standard for excipients as an annex to ISO 9001:2015
- Certifying Body competency qualification as an annex to ISO 17021-1:2015
- Auditor competency qualification as an annex to ISO 17021-1:2015