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.