What are some of the requirements for a cGMP Manufactured Product?

As a supplier of cGMP manufactured peptide products we must adhere to the following:

  • FDA registration and inspection.
  • Validated processes for manufacturing peptide products along with impurity profiles for those products.
  • Validated quality control test methods.
  • Stability peptide testing and documentation of stability.
  • QA (Quality Assurance) review of final QC (Quality Control) results.
  • cGMP training for all employees.
  • Packaging, handling, storage and distribution of the product, and a system to enable recall of a product if required.
  • Full traceability of all raw materials.
  • Yearly internal and external quality audits.
  • Product sample retention and a system to manage them.
  • Calibrated instrumentation with maintenance logs for critical or quality determining parameters.
  • Comprehensive documentation.
  • Providing Chemistry Manufacturing and Controls (CMC) guidance for our partners.