Standard Operating Procedure for Shift Handover Procedures in Biosimilar Manufacturing

Department	Biosimilars
SOP No.	SOP/BS/133/2025
Supersedes	SOP/BS/133/2022
Page No.	Page 1 of 10
Issue Date	04/05/2025
Effective Date	06/05/2025
Review Date	04/05/2026

1. Purpose

To define the procedure for effective shift handover between outgoing and incoming personnel in biosimilar manufacturing areas to ensure accurate communication, task continuity, and compliance with GMP practices.

2. Scope

This SOP applies to all biosimilar production, QC, engineering, and warehouse personnel involved in round-the-clock operations within the manufacturing facility.

3. Responsibilities

• Outgoing Shift Staff: Accurately document all ongoing and completed tasks, pending issues, deviations, and equipment status in the shift logbook.
• Incoming Shift Staff: Review the handover entries and clarify any ambiguities before accepting responsibility.
• Supervisors: Verify and sign off on the handover record and ensure issues are tracked to closure.

4. Accountability

The Production Manager is accountable for implementing and monitoring effective shift handovers in compliance with regulatory and internal quality requirements.

5. Procedure

5.1 Preparation for Handover

1. At least 30 minutes before shift end, outgoing personnel shall begin documenting:
   • Batch status and stage
   • Environmental readings
   • Equipment used and cleaned
   • Any alarms, excursions, or deviations
2. Use Annexure-1: Shift Handover Checklist to ensure standardization.

5.2 Verbal and Written Communication

1. Conduct face-to-face handover briefing in the designated control area.
2. Outgoing personnel shall walk through:
   • Critical status of ongoing batches
   • Pending sample collections
   • Ongoing equipment operations (e.g., incubation, fermenter runs)
3. Incoming personnel must ask clarifying questions if needed and sign the logbook post-review.

5.3 Handling Critical Observations

1. Any critical deviation, maintenance, or alert must be escalated verbally to the incoming supervisor.
2. Such issues shall be highlighted in the Annexure-2: Critical Handover Summary.

5.4 Shift Logbook Entry and Review

1. Each shift handover must be logged with:
   • Date and Time
   • Names and signatures of both outgoing and incoming staff
   • Summary of completed tasks and open items
2. Supervisor must review and sign within 1 hour of shift start.

5.5 Deviation Due to Poor Handover

1. If any production or quality failure is traced to improper handover:
   • QA to initiate a deviation
   • Root cause to be evaluated through Annexure-3: Handover Deviation Report
   • Re-training to be conducted as per SOP/BS/057/2025

6. Abbreviations

• QA: Quality Assurance
• GMP: Good Manufacturing Practice

7. Documents

1. Shift Handover Checklist – Annexure-1
2. Critical Handover Summary – Annexure-2
3. Handover Deviation Report – Annexure-3

8. References

• WHO GMP Guidelines – TRS 986
• EU GMP Chapter 1 – Pharmaceutical Quality System
• Internal SOP/BS/057/2025 – Personnel Training and Evaluation

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Shift Handover Checklist

Parameter	Status	Remarks
Batch Stage	Inoculation complete	Fed-batch started
Equipment Status	Cleaned	BR-200 ready
Environmental Readings	Within Limits	—

Annexure-2: Critical Handover Summary

Issue	Time	Description	Action Taken
pH probe alarm	04:15	Fluctuation beyond ±0.3	Calibrated

Annexure-3: Handover Deviation Report

Date	Deviation ID	Cause	Impact	CAPA
03/05/2025	DEV-HO-007	Batch info missing	Delay in feeding	Re-training done

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
04/05/2025	2.0	Checklist and deviation annexures added	Periodic SOP Update