Quality and Regulatory

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Quality and Regulatory

Quality and Regulatory

  • Well-equipped Quality control laboratory
  • Separate areas for wet analysis, HPLC, GC, control samples, stability chambers, balance room, hot room and microbiological analysis
  • Calibrated as per calibration calendar and maintained by AMC
  • Analysis of RM, PM, Intermediates. Finished Products and Stability samples
  • Monitoring of water system, clean rooms and products as applicable
  • Preparation, review and approval of SOPs, protocols and reports
  • Leading process validation, cleaning validation and analytical method transfers & process technology
  • The quality system is defined as per Schedule M, Schedule L, ICH Q7 and TRS guidelines
  • Issuance, retrieval, archival and control of documents
  • Release / Rejection of Raw materials and finished products
  • Qualification of vendors and contract laboratories
  • Self-inspection
  • Training and development of the staff
  • Trend analysis and annual product quality review
  • Investigating batch failures, deviations and complaints. Ensuring GMP compliance of the facility