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Quality Systems

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

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

Project Management

We will work closely with you throughout the project and adopt any previous chemistries that can shorten your clinical trials and reduce the risks in clinical filing complications.

  • Project tracking
  • Liaison to CPC operation
  • Cross-functional links from CPC operation to customer operation
  • Project history documentation
  • Customer-centric collaboration

Quality Control Facilities

GMP Peptide Analytical Equipment

Figure. State-of-the-art quality control laboratories at CPC Scientific.

Quality Assurance and Regulatory 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.

Quality assurance:

  • Batch record review
  • Document management and control
  • Deviations/Investigations
  • CAPA follow up and tracking
  • Complaint management
  • Product release

Regulatory support:

  • Phase appropriate control systems consulting
  • CMC compilation
  • DMF compilation and submission
  • Annual product reviews