SOP For In-Process Check During Filling of Dry Powder Suspension

SOP For In-Process Checks during filling of dry powder suspension is described in this post which you can follow in the section of the Quality Assurance Department. 

OBECTIVE

This procedure has been established to outline for in process inspection to be conducted during dry powder suspension filling to ensure the quality of product.

SCOPE 

This procedure is applicable to the Production Department of dry powder suspension manufacturing area

RESPONSIBILITY

QA Officer

ACCOUNTABILITY

Manager Quality Assurance 

PROCEDURE 

QA Officer ensures that powder filling area, 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 notes these on log sheet and sign at the time of line clearance.

QA Officer checks that the released label for filling issued by Q.C. is affixed on the machine.

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 bottles for filling are free from dust and moisture.

QA Officer checks the bottles blowing and drying record.

Before checking the weight variation, QA Officer confirms that the balance is calibrated and also checks calibration record of the balance & ensures that the filled weight should be in acceptable limits and weight variation test should be performed after every 30 minutes during the filling process

QA Officer checks that the caps of the bottles are properly crimped.  

QA Officer confirms that Seal test on empty bottles have been performed at the start and during the filling   process.

QA Officer checks that filled bottles should be clean and free of powder externally.

If any deviation is found it must be recorded in BMR.

If problem of weight variation or improper sealing persists, inform the QAM & Quarantine the production.