SOP on Decartoning of Vials.
Pharma Editor
September 24, 2016
Production
6,234 Views
- Objective:
- To lay down a procedure for Decartoning of Vials.
- Scope
- This SOP is applicable for Decartoning of vials.
- Responsibility
- Production officer / Executive.
- Accountability
- Production Head and Head QA shall be accountable for the compliance of SOP.
- Abbreviations
- Not Applicable
- Procedure
- Get the vials issued as per the batch requisition slip from warehouse and verify the quantity and analytical report number.
- Dedust the shipper of vials using a lint free cloth in decartoning room.
- Cut and remove the outer poly bag of the shipper, clean the shipper with lint free cloth in the vial decartoning room.
- Keep the shipper on the loading station. Open the box from topside.
- Activate the pneumatic mechanism such that the platform is raised slightly above the level of the inspection station.
- Transfer the vials manually by pushing with the stainless steel plate to the inspection station.
- Inspect the vials for any defects like, Moulding, Vial neck, Crack/Broken defects, and Black and Brown spot. and keep the defective vials in the rejected trays.
- Push the good inspected vials in to the plastic tray and load these vials in vial washing machine.
- Count the rejected vials and enter the rejected vials in Batch Production Record.
- Record the operation details in Batch production record.
- Forms and Records (Annexures)
- Not Applicable
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production
- History
| Date |
Revision Number |
Reason for Revision
|
| – |
00 |
New SOP |
