Standard Operating Procedure Title: SOP for Batch Travel

1. Purpose
• SOP is established to provide a standard procedure for the step wise completion of a product batch record starting from the issuance of materials up to its final packaging.
• SOP provides the procedure for record of personnel performing different tasks of manufacturing at various stages.
• SOP also helps trace the checks & controls subjected to the manufacturing processes.
• SOP outlines the procedure for reconciliation & batch yield calculation.
2. Scope
• Procedure is applicable to all manufacturing & packaging sections of production including the processes of issuance, manufacturing & packaging.
3. Responsibilities
• GM Production
• QC Manager
• Production Manager
• QA Manager
• Production Pharmacist
4. Reference:
• SOP for the issuance of Material (GL/SOP/P/001)
• SOP for Line Clearance (GL/SOP/008)
• SOP for Packaging Operation (GL/SOP/P/008)
• SOP for Destruction of Material (GL/SOP/P/002)
• SOP for the return of material to warehouse (GL/SOP/P/003)
• SOPs for Machinery & Equipment (All relevant SOPs)
5. Procedure
• Production Pharmacist initiates the file for the batch to be manufactured as per Weekly manufacturing schedule issued by Production Manager.
• Production Manager allots the batch number to the batch being manufactured in “Batch Manufacturing Log Book”.
• Production Pharmacist raises the Packaging/Raw Material requests of the batch as/when required & get material from store as per SOP for Issuance of Material from store ( ref: )
• Production Pharmacist files the “Batch Travel Sheet” in the batch file& assures fill of its relevant entries at each step of manufacture mentioned in “Batch Travel Sheet”. Separate “Batch Travel Sheets” are designed for all dosage forms.
• Production Pharmacist files all of the relevant documents (that are raised by different departments/sections at different steps of the manufacture e.g; reports, checklists, intimations etc.) in the batch file in an order mentioned in the “Batch File Index” filed at the top of the file.
• After the product has been finally packed & transferred to the finished goods quarantine Production Pharmacist reconciles the batch components used in manufacture & packing; he notes down his calculation on the batch travel sheet on the specified step.
• Finally Production Pharmacist calculates the yield of batch & hands the batch file over to the Production Manager.
• Production Manger checks the file & after necessary verification (if required) signs the file & sends it to the Auditor.
• Production Manager enters the batch yield & other required information in the “Batch Manufacturing Log Book”
• After auditing auditor sends back the batch file to the Production Manager for keeping the file in record.

6. Quality Record(s)/Form(s)
The following quality records shall be generated in accordance with the procedure for Control of Company Quality Records (GL/CQP/ )
Required Record Form No.
Raw Material Request Sheet QF/035/01
Line Clearance Intimation QF/055/01
Line Clearance QF/037/01
Request For Analysis QF/006/01
Approved QF/018/01
Batch Travel Sheet No of relevant dosage form
Check List For Packaging QF/025/01
Batch Manufacturing Log Book QF/
Destruction Note
Request For Return Of Raw/Packaging Material To Warehouse
Product Transfer Note
Quality Report
Checklist For Dispensing