Standard Operating Procedure for Cross-Department Communication During Upstream Events in Biosimilar Manufacturing

Department	Biosimilars
SOP No.	SOP/BS/150/2025
Supersedes	SOP/BS/150/2022
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 a structured communication framework for timely coordination among departments such as Production, QA, QC, and Engineering during upstream processing events in biosimilar manufacturing, ensuring consistency, safety, and GMP adherence.

2. Scope

This SOP applies to all personnel involved in upstream operations including seed preparation, inoculation, media preparation, bioreactor operations, and deviation handling in GMP zones of biosimilar facilities.

3. Responsibilities

• Production: Notify and document upstream events requiring input or support from other departments.
• QA: Review and approve interventions, deviations, and batch-related decisions.
• QC: Coordinate in-process testing and environmental monitoring.
• Engineering: Respond to equipment alarms, breakdowns, or maintenance needs.

4. Accountability

The Head of Production is accountable for ensuring proper interdepartmental communication is maintained and escalations are documented during critical upstream events.

5. Procedure

5.1 Communication Channels

1. Use of:
   • Intercom and secure messaging apps (approved internal platforms)
   • Radio communication (for classified zones)
   • Logbooks and digital communication logs
2. Escalation matrix shall be clearly displayed in the upstream production area.

5.2 Routine Notifications

1. Notify QC prior to:
   • Inoculation for in-process sampling
   • Harvest initiation for sample collection
2. Notify QA during:
   • Batch initiation
   • Batch closure
3. Document in Annexure-1: Interdepartmental Communication Log.

5.3 Critical Event Communication

1. Trigger urgent communication to QA and Engineering in case of:
   • Bioreactor alarms (temperature, DO, pH)
   • Contamination indicators
   • Utility failure (power, compressed air)
2. Use phone + message + email for redundancy.
3. Record timestamps of initial report and response in Annexure-2.

5.4 Meeting and Documentation

1. Daily coordination meetings between QA, QC, and Production are mandatory during GMP batch execution.
2. Meeting minutes and action items to be maintained in Annexure-3: Daily Communication Summary Sheet.

5.5 Documentation Review

1. QA shall periodically review the communication logs for completeness and consistency.
2. Deviations arising due to miscommunication to be recorded and investigated as per deviation SOP.

6. Abbreviations

• QA: Quality Assurance
• QC: Quality Control
• GMP: Good Manufacturing Practice

7. Documents

1. Interdepartmental Communication Log – Annexure-1
2. Critical Event Communication Tracker – Annexure-2
3. Daily Communication Summary Sheet – Annexure-3

8. References

• EU GMP Chapter 1 – Quality Management
• ICH Q10 – Pharmaceutical Quality System
• WHO TRS 986 – GMP for Biologics

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Interdepartmental Communication Log

Date	From	To	Event	Time	Mode	Remarks
03/05/2025	Production	QC	Seed transfer ready	09:30	Call + Logbook	Sampling done

Annexure-2: Critical Event Communication Tracker

Event	Date	Reported By	Department	Reported To	Response Time	Action Taken
DO Sensor Failure	03/05/2025	Ajay Verma	Production	Engineering	15 mins	Sensor replaced

Annexure-3: Daily Communication Summary Sheet

Date	Attendees	Topics Discussed	Decisions Made	Next Steps
03/05/2025	QA, QC, Production	Harvest plan	Initiate at 10:00	QC to standby

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
04/05/2025	2.0	Added escalation matrix, clarified critical event pathways	Process efficiency