In this article we are going to learn routine activity performed by IPQA Personnel in Tablet compression area

Introduction: In-Process Quality Assurance Person is responsible for line clearance activities and in this article, we are going to learn what activities he is going to perform routinely in the compression area are discussed here.

Line clearance:  In compression area line clearance will be for equipment and area. The area line clearance will be either Type-A or Type-B and equipment clearance is taken before area line clearance so that the compression operator can start fixing the machine and for taking the equipment line clearance in the compression area, all the equipment’s and its parts must be in cleaned state,

IPQA role in compression equipment clearance: The IPQA personnel will check all the logbooks and the checklists as per good documentation practices, before entering into area, he ensures the area is in cleaned state, then only he enters the area and wore the secondary gowning and enters into the area to check the cleanliness of equipment as per checklist and respective books. In compression area the following equipment’s and in process instruments are present like compression machine, Hardness- thickness & diameter tester, friability apparatus, disintegration apparatus, weighing balance for taking group weight, friability, etc. and it also contains sealing machine for packing compressed tablets and a torch light and magnifying glass for inspecting the tablets visually.

He checks all compression machine parts are clean, in process equipment are clean along with the area.

IPQA Role in Compression Area line clearance:

1.  Area status updated for the Current Product
2. Check the cleanliness of the area
3. Ensure no remnants of the previous products are present including documents
4. Check the cleanliness of equipment and also cleaned label affixed wherever necessary
5. Check out the equipment clearance checklist and then check the logbooks
6. He must check area cleaning logbooks, equipment cleaning logbooks, return air filters logbooks etc.
7. Then if the area clearance is type-b then fill the checklist by verifying each point and give clearance with initials and date in both the check list and the BMR
8. While giving clearance ensure the weighing balances are in calibrated state by verifying the daily calibration status from the respective logbooks
9. Also check the preventive maintenance status of the equipment and qualification status of them.

IN-PROCESS CHECKS:  The IPQA person shall perform the in Proces checks at assigned frequency

Rejects Verification: After compression process is completed, the rejects shall be verified by the IPQA personnel and should sign the reject label by checking the quantity and respective batch details and then he shall sign in the reject’s logbook.

Protocol studies, validations if any present shall be closely monitored by IPQA person by taking necessary samplings etc. wherever required