1.0 Objective:
To lay down a procedure on Batch Preparation of vial filling process.
2.0 Scope
This SOP is applicable for batch preparation of vial filling process.
3.0 Responsibility
Production Officers / Executive.
4.0 Accountability
Production Head shall be accountable for the compliance of SOP.
5.0 Abbreviations
SOP : Standard Operating Procedure.
RM : Raw Material
PM : Packing material
6.0 Procedure
6.1 Implementation / Action Steps
6.1.1 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:
6.1.2 Date of filling, Product, Batch Number, Number of vials to be filled, planned batch size, Container Closure system etc.
6.2 Issuance:
6.2.1 Fill the requisition for the issuance of Batch Production Record from Quality Assurance department a day before the start of batch processing duly signed by Production Supervisor /Officer.
6.2.2 Ensure that the Batch Production Record is issued by the Quality Assurance.
6.2.3 Plan the batch size as per marketing requirement or Raw material availability. Record this quantity as planned batch size in batch production record.
6.2.4 Fill Raw material, primary packing material issue slip in as per planned batch size and send it to RM/PM ware house incharge.
6.2.5 The ware house incharge is responsible for issuing the requisitioned material to concerned Production Officer / Supervisor along with duly completed requisition slip.
6.2.6 Ware house incharge retains one copy of issue slip.
6.2.7 Decarton 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.
6.2.8 Decarton the issued sterile raw material containers and transfer it to aseptic area as per SOP.
6.2.9 Transfer the issued vials to vial decartoning room and decarton the vials as per SOP.
6.3 Preparation:
6.3.1 Check following parameters / records in controlled area:
6.3.1.1 Cleanliness of the area.
6.3.1.2 Status tags of all machines.
6.3.1.3 Environmental condition.
6.3.1.4 Laminar Air Flow unit and its differential pressure with in limit.
6.3.1.5 Operational status of vial washing machine, sterilizing tunnel and bung processor cum steam sterilizer parameters.
6.3.1.6 Water supply and their Quality Control Reports.
6.3.1.7 Utility supplies such as compressed Air, nitrogen, carbon dioxide etc.
6.3.1.8 Line clearance of area and aseptic area.
6.3.2 Check following parameters / records of aseptic area:
6.3.2.1 Cleaning / Sanitization / Disinfection of area.
6.3.2.2 Environmental conditions Relative Humidity, Temperature and Viable and Non viable air borne particulate counts.
6.3.2.3 Assembling of machine and availability of sterile vials, Rubber stoppers and Raw material.
6.3.2.4 Gowning in aseptic area.
6.3.2.5 Line clearance of the area and the machine.
6.3.2.6 Operational status of all machines.
6.3.4 Check the following parameters in packing area
6.3.4.1 Line clearance on packing line.
6.3.4.2 Coding matter of packing components as per pack specifications.
6.3.4.3 Status tags of all machines.
7.0 Forms and Records
Not Applicable
8.0 Distribution
Master copy – Quality Assurance
Controlled copies – Quality Assurance, Production, Quality Control
9.0 History
| Date | Revision Number |
Reason for Revision |
| – | 00 | New SOP |
