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.