CPC Scientific

CGMP Compliance

CGMP Compliance

A dedicated Quality department verifies full CGMP compliance throughout production, as well as testing and documentation standards in accordance with the most stringent FDA requirements.

• 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

CGMP Specifications

Our CGMP specifications and testing procedures include the following:

• Appearance: white to off-white solid
• Solubility: Clear solution at a predefined concentration
• Purity (HPLC, UPLC): 95-98% specific to phase of development
• Molecular weight (MS)
• AAA (Amino Acid Analysis): ±10% of theoretical
• Peptide content: ≥70%
• Counter-ion content
• Moisture content (Karl Fisher): ≤10%
• Residual Solvent Content: GC-MS
• Residual trifluoroacetic acid: ≤0.1%