SOP for Batch Preparation of Vial Filling Process

PURPOSE

This SOP aims to outline the procedure for the Batch Preparation of the Vial Filling Process.

SCOPE

This SOP applies to all injectable products manufactured within the facility.

RESPONSIBILITY

Production Department: Responsible for Batch Preparation of Vial Filling Process.

PROCEDURE

Implementation / Action Steps:

• According to the Marketing requirement, Raw material availability, the number of vials to be filled is planned.
• The production head instructs the Production Officer to plan for batch manufacturing as per the following details:
• Date of filling, Product, Batch Number, Number of vials to be filled, planned batch size, Container Closure system etc.

Issuance:

• Fill the requisition for the issuance of the Batch Production Record from the Quality Assurance department a day before the start of batch processing duly signed by the Production Supervisor /Officer.
• Ensure that the Batch Production Record is issued by the Quality Assurance Plan the batch size as per marketing requirement or Raw material availability.
• Record this quantity as planned batch size in batch production record.
• Fill Raw material, primary packing material issue slip in as per planned batch size and send it to RM/PM warehouse in charge.
• The warehouse in charge is responsible for issuing the requisitioned material to the concerned Production Officer / Supervisor along with duly completed requisition slip.
• Warehouse in charge retains one copy of issue slip. Decatron the issued primary packing material (rubber stopper and flip off aluminum seals) and secondary packing material (vial label, unit carton, ampoules and shipper boxes) and transfer it to respective area as per SOP.
• De-carton the issued sterile raw material containers and transfer it to aseptic area as per SOP.
• Transfer the issued vials to vial de-cartooning room and de-carton the vials as per SOP.

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Preparation:

1. Check the following parameters/records in the controlled area:

• Cleanliness of the area.Status tags of all machines.
• Environmental condition.Laminar Air Flow unit and its differential pressure within the limit.
• Operational status of vial washing machine, sterilizing tunnel and bung processor cum steam sterilizer parameters.
• Water supply and their Quality Control Reports.
• Utility supplies such as compressed Air, nitrogen, carbon dioxide etc.
• Line clearance of area and aseptic area.

2. Check the following parameters/records of the aseptic area:

• Cleaning / Sanitization / Disinfection of area.
• Environmental conditions Relative Humidity, Temperature and Viable and Non-viable air-borne particulate counts.
• Assembling of machine and availability of sterile vials, Rubber stoppers and Raw material.
• Gowning in aseptic area.Line clearance of the area and the machine.
• Operational status of all machines.

3. Check the following parameters in the packing area

• Line clearance on the packing line.
• Coding matter of packing components as per pack specifications.
• Status tags of all machines.

ANNEXURES

Nil

ABBREVIATIONS

SOP : Standard Operating Procedure.

RM : Raw Material

PM : Packing material

REVISION HISTORY

Nil

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