SOP For In-Process Checks During Aseptic (Injection) Filling

SOP For In-Process Checks during Aseptic (Injection) 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 aseptic filling to ensure the quality and sterility of product.

SCOPE 

This procedure is applicable to the Production Department of injection manufacturing area

RESPONSIBILITY

QA Officer

ACCOUNTABILITY

Manager Quality Assurance 

PROCEDURE 

Filling should be allowed after receiving the Microbiological report of area clearance.

Check the required relative humidity, temperature, Positive Pressure & related documentation before starting the filling operation.

Make sure that all precautions for sterile gowning have been followed and the personnel working in the sterile area has filled the hygiene certificate.

Ensure that the sterilization records of the area, equipment (Dry heat Sterilizer and Autoclave) are properly maintained.

The required relative humidity, positive pressure and temperature should be maintained throughout the filling operation.

Check that the active material has been released by Q.C. for filling.

Before start filling, check the stamps of active material & components verification.

These stamps should be filled & signed according to the product to be filled.

Check the Weights of contents by random sampling of five vials after one-hour interval alternatively by Production and Quality Assurance and record on the in process control form in the BMR. 

Check that filled vials are properly sealed. Any deviation should be noted & highlighted.

If problem persists, stop the production and take necessary action and report to the QA department

Witness the area environment monitoring by settle plate method at the end of filling operation.