GMP Compliance & Certification

CPC manufactures peptide active pharmaceutical ingredients (APIs) in accordance with FDA/EU cGMP guidelines, which include:

• Code of Federal Regulations Part 210/211 (21 CFR 210/211)

• ICH Q7 (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7)

Check our audition and Inspection History here:

GMP Compliance History Timeliness

CGMP Compliance

The CPC Quality department is committed to ensuring complete adherence to CGMP standards at every stage of production. Additionally, they rigorously uphold testing and documentation protocols in alignment with the most stringent FDA stipulations.

• In-process, release and environmental control testing performed

• Standard release testing performed in-house

• Audited contract laboratories available for additional testing

• Method development and validation, formal method transfer

• Stability studies (ICH) and forced degradation