approval.

Verify that the material’s status (quarantine, approved, or rejected) aligns with the movement request.

Approval Process:

• The Warehouse Supervisor reviews the request, confirms availability of storage space, and authorizes the movement.
• Document approval details in the Movement Authorization Log (Annexure-2).

5.2 Material Movement Documentation

1. Recording Movement Details:
   • Record each movement in the Raw Material Movement Log (Annexure-3), including material name, batch number, origin, destination, and reason for movement.
   • Ensure dual verification (by two warehouse personnel) of high-risk material movements.
2. Barcode Scanning (if applicable):
   • Use barcode scanners to track movement electronically and link the data to the Warehouse Management System (WMS).
   • Maintain digital logs in the Electronic Movement Record (Annexure-4).

5.3 Special Handling and Segregation

1. Hazardous and Sensitive Materials:
   • Follow special handling procedures for hazardous, temperature-sensitive, or light-sensitive materials.
   • Document these movements separately in the Special Material Movement Log (Annexure-5).
2. Segregation Requirements:
   • Ensure materials with different statuses (approved, rejected, quarantined) are moved to clearly marked and segregated areas.
   • Update the Segregation Compliance Log (Annexure-6) after each movement.

5.4 Reconciliation and Audit

1. Daily Reconciliation:
   • At the end of each day, reconcile physical inventory with documented movements.
   • Record reconciliation findings in the Daily Movement Reconciliation Log (Annexure-7).
2. QA Audits:
   • The QA department conducts weekly audits of movement records to verify compliance.
   • Document audit findings in the Movement Audit Log (Annexure-8).

5.5 Training and Compliance

1. Employee Training:
   • Conduct quarterly training sessions for warehouse staff on movement documentation protocols.
   • Maintain training records in the Movement Documentation Training Log (Annexure-9).
2. Regulatory Compliance:
   • Ensure that documentation practices align with GMP, FDA, and WHO standards.
   • Conduct bi-annual reviews of SOP effectiveness and compliance.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• WMS: Warehouse Management System

7. Documents

1. Raw Material Movement Request Form (Annexure-1)
2. Movement Authorization Log (Annexure-2)
3. Raw Material Movement Log (Annexure-3)
4. Electronic Movement Record (Annexure-4)
5. Special Material Movement Log (Annexure-5)
6. Segregation Compliance Log (Annexure-6)
7. Daily Movement Reconciliation Log (Annexure-7)
8. Movement Audit Log (Annexure-8)
9. Movement Documentation Training Log (Annexure-9)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO Guidelines on Good Storage and Distribution Practices
• FDA Guidance for Industry on Documentation Standards

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Raw Material Movement Request Form

Date	Material Name	Batch Number	Current Location	Requested Location	Reason for Movement	Requested By
08/04/2025	API X	Batch 12345	Quarantine Area	Approved Storage	QC Approval Received	Ravi Kumar

Annexure-2: Movement Authorization Log

Date	Material Name	Batch Number	Authorized By	Signature
08/04/2025	API X	Batch 12345	Neha Verma

Annexure-3: Raw Material Movement Log

Date	Material Name	Batch Number	Origin	Destination	Moved By	Verified By
08/04/2025	API X	Batch 12345	Quarantine Area	Approved Storage	Amit Joshi	Priya Singh

Annexure-4: Electronic Movement Record

Date	Material Name	Batch Number	Movement ID	Logged By	Verified By
08/04/2025	API X	Batch 12345	EMR001	Ravi Kumar	Neha Verma

Annexure-5: Special Material Movement Log

Date	Material Name	Batch Number	Type	Origin	Destination	Handled By
08/04/2025	Hazardous Solvent Y	Batch 67890	Flammable	Hazardous Storage	Processing Area	Ajay Sharma

Annexure-6: Segregation Compliance Log

Date	Material Name	Batch Number	Original Status	New Status	Moved By	Reviewed By
08/04/2025	API Z	Batch 11223	Quarantine	Approved	Kiran Patel	QA Officer

Annexure-7: Daily Movement Reconciliation Log

Date	Total Movements Recorded	Physical Verification Status	Verified By	Remarks
08/04/2025	15	Matched	QA Auditor	No Discrepancies

Annexure-8: Movement Audit Log

Date	Audit Conducted By	Total Records Reviewed	Findings	Corrective Actions
08/04/2025	QA Manager	20	One Missing Entry	Re-training Conducted

Annexure-9: Movement Documentation Training Log

Date	Employee Name	Training Topic	Trainer	Remarks
08/04/2025	Sanjay Mehta	Material Movement Documentation	QA Supervisor	Successfully Completed

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Implementation	QA Head
08/04/2025	2.0	Updated documentation processes and added electronic tracking logs.	Regulatory Update	QA Head