JAFRAL offers production of GMP and non-GMP biomolecules
JAFRAL’s manufacturing of various biomolecules, whether Active Pharmaceutical Ingredients (APIs)/Drug Substances (DS) or Drug Products (DP) are based on three corner stones:
- Innovative and reliable manufacturing techniques
- Constant Quality Control (QC), which starts to be implemented already at testing Raw materials and then proceeds to be implemented for In-Process testing and finally for Release QC testing.
- Lean Documentation system. JAFRAL’s Quality Assurance system is in charge of overseeing the entire production process from validation of equipment to the approval of the documents released (SOPs, batch records, validation reports, etc.) to release the GMP product.
JAFRAL’s facility was designed to manufacture various products in parallel. Segregation and campaign basis manufacturing approach coupled with validated change-over and cleaning procedures between projects assure integrity of manufactured products.