IPQC or In Process Quality Control is a controlling procedure of pharmaceutical products quality during manufacturing. A IPQC personnel need to monitor following activities - 


IPQC Checks During Manufacturing

  • Environmental Monitoring.
  • Ensure Name, Strength, & Batch size is correct.
  • Ensure right material is received for dispensing.
  • Ensure API calculation is correct.
  • Ensure all process equipment is clean.
  • Ensure operators are trained on the process.
  • Ensure process is followed correctly.
  • Check the intermediate product (granules, core tablets, coated tablets etc.) parameter is meet correctly.
  • Raised deviation if process not meet the target specification.
  • Notify engineering department immediately if machine breakdown or power-off occurred.
  • Ensure IPC checklist fill-up accordingly.

IPQC Checks During Packaging

  • Environmental Monitoring.
  • Ensure Name, Strength, Volume & Quantity is correct.
  • Check the status labels on equipment, area & in process container.
  • Over printing quality.
  • Batch coding details on primary & secondary pack (B.No., Mfg., Exp., M.R.P. etc.).
  • Text matter on the ptd. foil & carton.
  • Verification forming & sealing temperature.
  • Ensure blisters are free from knurling defects.
  • Leak Test.
  • Pharmacopeial status of the material used is correct.
  • Mfg. License number is printed correctly.
  • Preprinted packing materials provide mandatory information & legal status.
  • Storage conditions details available in the packaging materials.
  • Directions for use details available in the packaging materials.
  • Ensure warnings against wrong administration is provided in the pack.
  • Storage condition is same all printed packing Materials.
  • Ensure correct leaflet is used for the product.
  • Verify printed matter on the outer cartons and shippers.
  • Ensure checkers are performing their activity in a proper way.
  • Verify blisters & strips for alignment defects & empty pockets.
  • Ensure doors are closed during processing.
  • Verify the records for online entries.
  • Sampling

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