QUALITY FOCUS

 

The company aims at achieving quality excellence and customer satisfaction through good manufacturing practices and strives for continuous improvements

All its manufacturing facilities are ISO 9001:2008 and WHO GMP compliant

SMS has developed fully equipped quality control cells at all the manufacturing facilities manned by experienced and qualified staff having hands on experience.

Each of these QA/QC blocks are comprised of fully equipped Wet Lab, Instrumentation Lab, and Microbiology Lab to carry intermediate, in-process, and final product analysis 

 

Some of the instrumentation in our QA/QC blocks include

  • HPLCs
  • GC with Headspace
  • FT-IR & UV Spectrophotometers 
  • TOC Analyzer
  • LBPC
  • Polarimeter
  • Purified Water System (RO and EDI)
  • On-line Air-borne Particle Counter
  • Clean Room Validation Equipment etc.

 

SMS has the required capabilities and infrastructure to ensure full operation of the quality function from raw material analysis to in-process analysis and analysis of final products. SMS puts utmost important to quality and hence rigourously carries out:
 

 

  • Stability monitoring as per ICH guidelines to confirm appropriate storage conditions and to assign the self life of each product
  • Reserve/ Retention samples study program for the purpose of potential future evaluation of the Quality.
  • Validation program
  • OOS investigation
  • Change control program
  • Microtesting of water, facility and products
  • Handling of Complaints and recalls to satisfy the customers
  • CGMP documentation and commitments