FDA GMP and cGMP Compliance Audits

Several years ago, ANAB was asked to include cGMP criteria during our regular assessments for accreditation.  We developed a program for a few areas, including dietary supplements and finished pharmaceuticals, and infused these into our regular work. At the time, this was a simple solution for ANAB because none of our customers were accredited by ANAB for ISO/IEC 17020 with cGMP on the scope.

ANAB now has accredited an inspection body to ISO/IEC 17020 with cGMP on the scope of accreditation. It has always been ANAB policy to not compete with our customers, so ANAB is no longer assessing to the cGMP requirements, whether as a standalone assessment and or in conjunction with an assessment to an ISO standard.

For customers previously assessed by ANAB, we will keep the cGMP scope item active until March 1, 2018. After that date, ANAB will no longer support cGMP assessments. Instead, ANAB likely will direct customers to an ANAB accredited inspection body if they need another provider for these services.

For more information, contact Roger Muse,

rmuse@anab.org

414-501-5455.