Quality Assurance

The production staff is specially trained with an emphasis on adherence to work instructions, maintenance of the aseptic atmosphere and the utmost attention to issues of quality. All aspects of production process, including facility operation and maintenance, incoming material procedures, the actual work, sampling and quality assurance, are defined in a set of Standard Operating Procedures.

  • All materials are supplied by approved suppliers.
  • Comprehensive in-process control is performed.
  • The entire production process is documented.
  • Dispensing and assembling take place in Class C (10,000) and local Class A (100) clean rooms.
  • The clean rooms are regularly tested for air inlet velocity, particles and sterility.

A Certificate of Analysis accompanies each order.

QC Inspection Centre is fully equipped with HPLC, LC-MS, GC, ICP-MS, TOC, NMR Spectrometer, FTIR, UV Scanner, Waters PrepLC etc.