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  • Increased Regulatory audits to ensure quality and compliance.
  • e-Pedigree laws being implemented for preventing counterfeit drugs.
  • Warning letters and import restrictions. Key reasons:
    • Data documentation discipline,
    • Data integrity,
    • Due process failures,
    • Hygiene standards,
    • Lack of procedural awareness
  • Many companies fail in clearing surprise Regulatory audits.


  • Dispensing material using FEFO and FIFO rule
  • Timely raw material re-testing
  • Timely equipment calibration
  • Equipment maintenance and manufacturing date conflicts
  • Master and Batch Record maintenance
  • Deviation documentation challenge
  • Data documentation discipline


The configurability of Chemia allows the users to:

  • Adopting modern technology
  • Track and trace limited to batch numbering
  • Packaging lines not geared to adopt track and trace

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