cGMP

QC / QA

Our commitment to quality is reflected throughout the manufacturing process. Starting materials of the highest quality are purchased from qualified vendors and carefully evaluated by our Quality Assurance Department prior to use. In our Quality Control Department, the final product is subjected to a battery of analytical tests. You are assured of consistent, reliable and timely supplies of ultra-pure pharmaceutical-grade peptides.

Quality - 2009 (PDF - 769 KB)

 

Quality Control Tests
Our GMP manufacturing facilities, procedures, and documentation are maintained in accordance with current Good Manufacturing Practice as described in the United States Code of Federal Regulations and ICH Guidance Q7A for Active Pharmaceutical Ingredients.

We work with you to determine the preliminary specifications for the quality and composition of your peptide during pilot manufacturing runs.

cGMP Certificate of Analysis
Every product manufactured under cGMP undergoes a battery of analytical tests. Each batch is provided with a lot-specific certificate of analysis (COA) documenting specifications, test methods and results. Some of the common tests found on a COA include:

  • Color/Appearance
  • Water Content by Karl Fischer
  • Identity and Purity by HPLC
  • Amino Acid Analysis
  • Molecular Weight
  • Peptide Content by Nitrogen Analysis
  • Acetate Content by HPLC
  • Trifluoroacetic Acid (TFA) Content by HPLC
  • Related Substances (Impurities) by HPLC
  • Residual Solvents by GC-MS
  • Sequencing by MS-MS
  • Mass Balance
  • Heavy Metals by ICP-MS
  • Specific Optical Rotation
  • Bioburden
  • Endotoxin by LAL
  • Solubility

Quality System

  • Quality Policy and Quality Manual
  • Manufacturing Process Controls
  • QC Specifications to Match Customer Specific Requirements
  • Complete Quality System with Tier 2 and Tier 3 Standard Operating Procedures (SOP)
  • Qualified and Trained Personnel
  • FDA Licensed GMP Facility
  • Environmental and Facility Controls
  • Quality Agreements
  • Supplier Qualification, Audits and Raw Material QC Testing / QA Final Release
  • Unique Master Batch Record for Each Lot
  • QC Laboratory Controls
  • Equipment Calibration and Maintenance
  • Qualification and Validation Program
  • Quality Systems for Change Control and Notification
  • Internal Audits
  • Training