Quality Assurance

Quality is the mainstay of our competitiveness. Our objective is to constantly achieve QUALITY EXCELLENCE. To achieve this, we take considerable focus in adherence to the QA policies. Quality Assurance, though an independent function, works as an interface between R&D and manufacturing strictly abiding with the standardized quality system, providing consistency, effectiveness and efficiency for all manufacturing activities across all our manufacturing locations. An excellent team of professionals having good understanding of concepts of quality systems and cGMP is working to ensure quality assurance at each stage right from receiving of starting materials to finished products to assure the highest international standards.

The major functions covered under the umbrella of quality assurance:

  • All validation activities including-
    • System validation such as Water system, HVAC system, Compressed air & Nitogen
    • Facilities validation such as Room qualification(RQ)
    • Machine/Equipment validation (IQ, OQ, PQ)
    • Process simulation study for aseptic product (Media fill trial)
    • Process validation
    • Analytical method validation
  • Approval of raw & packaging materials
  • Monitoring of manufacturing processes through in-process control
  • Approval of finished products & batch release
  • Implementation of cGMP
  • Documentation of technical information including dossier

Quality Control

Our Quality Control Laboratory is equipped with highly sophisticated equipment to conform “Good Laboratory Practice” guideline so as to guarantee consistent product quality. We have got the machineries as follows:

  • UPLC (Ultra Performance Liquid Chromatography)
  • HPLC (High Performance Liquid Chromatography)
  • GC (Gas Chromatography)
  • TOC (Total Organic Carbon) Analyzer
  • Atomic Absorption Spectrophotometer etc.

Focuses on review of failures, rejections, market complaints, deviations, non-compliances, and various corrective & preventive actions, the goal is to reduce quality management system (QMS) more robust and consistent.

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