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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