With all its manufacturing units equipped with latest high precision instruments, Morepen has spared no efforts to raise its quality standards to international levels.

Quality Assurance plays a very important role in making sure that the GMP standards are met and products comply with the international quality standards. The main functions carried out by this department are as under:

• Approval of raw materials
• Monitoring of manufacturing processes
• Approval of finished products
• Documentation of technical information
  (DMF, PRMF, EDMF & Dossiers etc.)
• Implementation of cGMP

Quality Assurance Dept. has an excellent team of professionals having good understanding of concepts of quality systems and cGMP. Manufacturing processes are monitored and controlled by testing of raw materials, in-process parameters.

Final active pharmaceutical ingredients and dosage forms are tested for specified parameters before release. Analytical testing is carried out with highly sophisticated instruments viz. HPLC, GC, IR, UV spectrophotometer mettler titrators, particle size analyzer etc.

Records of manufacturing are properly documented.

All the analytical test procedures and manufacturing procedures are well documented and revision is undertaken as per specified protocol. Analytical methods are validated to give the reproducible results. Stability study as per stability protocol is considered to be very important area of Quality Assurance.

Copyright © QuGen Inc. All rights reserved