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
cGMP manufacturing facilities, procedures, and documentation are maintained in accordance with current Good Manufacturing Practice as described in the United States Code of Federal Regulations.

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. A typical COA contains the following information:

Appearance
Solubility
Purity by gradient HPLC
Molecular Weight by M.S.
Peptide content
Counter ion content
Water content
Residual organic solvent content
Endotoxin

Quality System

QA release of Master BPR specifically for each lot
QC testing of Raw Materials / QA final release
QC compilation of results during final testing of drug substance compared to specifications (incl.CoA)
Creation of a document set including BPR, SOP's, list of materials/equipment, list of assays and specifications, monitoring of intermediates and final product quality
Recalls and Complaints, Training, Stability Protocol execution