- Objective:
- To lay down a procedure for final packing of products
- Scope
- This SOP is applicable for final packing of products for Production dry powder Injection facility.
- Responsibility
- Officers or above – Production.
- Accountability
- Production Head.
- Abbreviations
- SOP : Standard Operating Procedure.
- BOPP : Biaxial Oriented Poly Propylene.
- MFG. : Manufacturing
- EXP. : Expiry
- Procedure
- Manual Packing of Vials :
- Obtain the line clearance as per SOP from production & In-process Quality Assurance officer before starting the packing operation and enter the line clearance in Batch Production Record.
- Obtain the Packing Materials from Production Officer as per Secondary Packing Material requisition from warehouse.
- Check that the packing materials are received as per Secondary Packing Material Requisition to meet the pack specifications. Get them checked from the Production Officer and record in the Batch Production Record.
- Before start the packing operation, check that the coding on unit cartons as per the batch details.
- Sticker the label on the visually inspected good vials & checks the labeled vials for proper coding & pasting of labels.
- Packing for Indian market :
- Put labeled vials into the coded unit carton as per the packing specifications of the particular product along with sterile water for injection. Fold the unit carton. Folded unit carton packed in 5,10,15 or 25 vials intermediate box and Label it.
- Packing for export market :
- Put the labeled vials into coded unit carton as per the packing specifications of the particular product along with pack insert (literature) & ampoule (if required) fold the unit carton. Folded unit carton packed in 5,10,15 or 25 vials intermediate box and Label it.
- Put the labeled vials into the 5,10,15 or 25 vials intermediate box with partition along with 5,10,15 or 25 nos. water for injection ampoules (if required). Fold the intermediate box and label it.
- Weigh of each 5,10,15 or 25 vials box on the weighing balance and reject if the weight of any box is observed below the standard limit as the box may not contain one / more component in any of the pack.
- Pack intermediate box in a final shipper box as per the pack specifications.
- Put the Packing Slip inside the shipper box.
- Seal each shipper box by BOPP tape.
- Over print the batch details (product name, batch no. batch size, mfg date, exp.date) on the shipper box.
- Strapthe box in case of export packing.
- After BOPP taping / strapping weigh each shipper box by weighing balance and write the actual weight in shipper box weighing register.
- Record the packing operation in equipment log book as per SOP & get it checked by production officer. .
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
- History
Date Revision Number Reason for Revision
– 00 New SOP
