SOP For In-Process Checks during capsule filling is described in this post which you can follow in the section of the Quality Assurance Department.
This procedure has been established to outline for in process inspection to be conducted during capsule filling to ensure the quality of product.
SCOPE
This procedure is applicable to the Production Department of capsule manufacturing area
RESPONSIBILITY
QA Officer
ACCOUNTABILITY
Manager Quality Assurance
PROCEDURE
QA Officer ensures that capsule filling area, capsule filling machine and balance is clean and free from dust, powder or foreign matter.
QA Officer ensures that no other material except the relevant batch should be present in the area.
QA Officer checks the relative humidity and temperature recommended for the product to be filled and Production Officer notes these on log sheet and signed by both QA and Production Officer at the time of line clearance.
QA Officer should also check swab test report of hopper in the BMR before giving line clearance. If not done, then perform swab test.
QA Officer checks that the bulk containers are clean and are properly labeled indicating Name of Product, Batch No, Batch Size, Process/Status, Signature (Production Officer) and Date.
QA Officer checks that the released label for filling issued by Q.C. is affixed on the container / machine.
QA Officer ensures that the empty capsule gels are dust free.
QA Officer checks that the filled capsules are properly locked.
QA Officer checks the filled capsules for dented or pressed capsules.
Before checking the weight variation, QA Officer confirms that the balance is calibrated and also checks calibration record of the balance.
Weight variation test should be performed on 10 capsules after every half an hour alternatively by QA and Production Officers and should be recorded on in-process sheets in BMR.
If any deviation found, it must be recorded in BMR.
If problem persists, informed the QAM and Quarantine the production
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