Quality for Late-Stage and Commercial Manufacturing:
CPC Scientific ensures the highest quality standards for late-stage and commercial peptide manufacturing, adhering to rigorous cGMP guidelines and comprehensive testing protocols. Support for IND and NDA Filings: We provide complete regulatory support for your IND and NDA filings in the USA, along with all international filings, ensuring seamless compliance for your peptide APIs from development to commercialization.
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%
- Bioburden: Report Aerobic and Spore Count, USP guidelines
- Endotoxin: Report LAL (Gel Clot), USP guidelines
- Elemental Analysis (ICP-MS): Report results for the following metals: Sb, As, Bi, Cd, Cu, Pb, Hg, Mo, Ag, Sn
Inspection History
| Year | Regulatory | Inspection Type |
|---|---|---|
| 2025 | ISO 22716 | Cosmetic GMP Certificate |
| 2024 | FDA | 5th FDA Inspection |
| 2024 | TGA | GMP Audit |
| 2023 | NMPA | Registration Inspection GMP Inspection |
| 2022 | NMPA | Registration Inspection GMP Inspection |
| 2019 | MFDS | GMP Inspection |
| 2019 | NMPA | GMP Certification |
| 2018 | EMA | GMP Inspection |
| 2016 | FDA | 4th FDA Inspection (on-site, no 483) |
| 2014 | FDA | 3rd FDA Inspection (on-site, no 483) |
| 2012 | FDA | 2nd FDA Inspection (on-site, no 483) |
| 2011 | FDA | 1st FDA Inspection (on-site, no 483) |
| 2009 | NMPA | GMP Certification |
| 2006 | NMPA | GMP Certification |
| 2005 | ISO 9001 | GMP Certification |
IND and NDA Support
CPC Scientific provides complete support for your IND and NDA filings in the USA as well as all international filings and all required regulatory support for your peptide APIs.
- Batch record review
- Document management and control
- Deviations/Investigations
- CAPA follow up and tracking
- Complaint management
- Product release
- Phase appropriate control systems consulting
- CMC compilation
- DMF compilation and submission
- Annual product reviews
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
Analytical Chromatographic Techniques
High Performance Liquid Chromatography (UHPLC/HPLC)
UV Diode Array
Fluorescence
Charged Aerosol Detector (CAD)
Refractive Index (RI)
Multi Angle Light Scattering (MALS) detection