CSQ PHARMA-GMP
ADDENDUM
CSQ PHARMA-GMP ADDENDUM
The CSQ Pharma-GMP Addendum is a scope expansion for CSQ Certified, Level 3, licensed operations cultivating, processing, producing, handling, storing, distributing, and/or selling cannabinoid herbal materials, substances, and/or products as medicinal cannabinoid products.
The CSQ Pharma-GMP Addendum can be added to any Level 3, CSQ Certification. The CSQ Pharma-GMP Addendum Audit Requirements are in addition to the applicable CSQ Audit Requirements.
The CSQ Pharma-GMP Addendum incorporates the regulatory requirements in US 21 CFR 210 & 211 and EudraLex Volume 4 Part 1 & 2 and their associated annexes and guidance documents, and ASTM, ICH, ISO, cGACP, cGMP, cGDP, HACCP, HARPC, AHPA, USP, Ph. Eur. and other internationally recognized standards and best practices for botanical drug product and herbal medicinal product safety and quality.
DISCLAIMER: The CSQ Pharma-GMP Addendum is a private third-party conformity assessment and is NOT the same as an EU Competent Authority GMP certificate, Manufacturing/Import Authorization (MIA), Marketing Authorization (MA), EudraGMDP entry, or Qualified Person (QP) batch certification/release; nor is it the same as an US FDA/DEA authorization/registration or New Drug Application (NDA); or any other market/regulatory authorization/registration or special-access permission granted by an Authority Having Jurisdiction/Competent Authority.