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Quality Policy

Quality Assurance

  • Strict In-process Quality Checks at all stages of operation
  • Sampling of products at all stages (Process Blend,¬† Intermediate and Finished Products)

  • Internal Quality Audits/Self Inspection and Evaluation
  • Complaint handling and Reporting.
  • Deviation control, Change Control and Incident Report
  • Out of specifications results
  • Annual product quality review
  • Control of Master Documents, Formats, BMRs & BPRs.
  • Validation
    • As per approved Validation Master Plan
    • Equipment Qualification (DQ, IQ, OQ and PQ)
      -Process Validation
      -Area Validation
      -Cleaning Validation
      -Vendor Qualification and Rating
      -Analytical Method Validation
  • Requalification & Revalidation

Quality Control Laboratory

  • In-house analysis of all Raw / Packing Material receipts, Intermediate & formulated finished products
  • Separate area for Physicochemical analysis,¬† Instrumental analysis & Microbiological¬† analysis
  • Separate section for Documentation & Stability Chambers.
  • Wet Chemistry Section
    Furnished with Fuming chamber, hot zone, Eye Wash and Bath facility.
  • Instrumentation Section
    HPLC, FTIR, UV, KF Titrator, Dissolution Apparatus, Polarimeter, Analytical Balances and other sophisticated instruments
  • Microbiology Section
    Separate Microbial Limit Test & Bioassay Area with LAF and HVAC facility.
    Separate autoclaves for sterilization and disposal of discards.