APIs, excipients, preservatives, and packaging components intended for use in the manufacturing of gel-based pharmaceutical formulations in the Gel Manufacturing department.

3. Responsibilities

• Warehouse Officer: Responsible for checking, recording, labeling, and storage of incoming materials.
• QC Officer: Responsible for sampling and analysis of received materials.
• QA Officer: Responsible for releasing materials based on QC results and ensuring GMP compliance.

4. Accountability

The Head – Manufacturing is accountable for implementing and ensuring adherence to this procedure in coordination with warehouse and quality units.

5. Procedure

5.1 Material Receipt

1. Receive materials at the warehouse receiving bay from approved vendors.
2. Verify the material against the delivery challan, purchase order, and material code.
3. Inspect the outer condition of the containers for damage, labeling, and seal integrity.
4. Assign a Goods Receipt Note (GRN) number and record in the Raw Material Receipt Register – Annexure-1.
5. Affix “UNDER TEST” label on each container and move it to the quarantine area.

5.2 Sampling and Testing

1. Inform Quality Control for sampling.
2. Perform sampling as per SOP for sampling of raw materials in a designated sampling room.
3. Send samples to QC lab with appropriate labels and intimation.

5.3 Storage of Materials

1. Segregate materials into:
   • Quarantine
   • Approved
   • Rejected
2. Store materials under defined storage conditions (ambient, cold, light-protected) based on COA or MSDS.
3. Use FIFO (First In First Out) or FEFO (First Expiry First Out) for inventory rotation.
4. Maintain material traceability using bin cards and ERP entries.

5.4 Handling of Rejected Materials

1. QC to issue rejection note and QA to affix “REJECTED” label.
2. Move rejected materials to a designated rejection area under lock and key.
3. Dispose as per SOP on Disposal of Rejected Materials.

5.5 Issuance to Production

1. Only approved and released materials shall be issued to manufacturing as per batch requirement.
2. Record material issuance in the Material Dispensing Register and link to Batch Manufacturing Record (BMR).

6. Abbreviations

• GRN: Goods Receipt Note
• QC: Quality Control
• QA: Quality Assurance
• ERP: Enterprise Resource Planning

7. Documents

1. Raw Material Receipt Register – Annexure-1
2. Sampling Request Form – Annexure-2
3. Material Rejection Note – Annexure-3
4. Material Dispensing Register – Annexure-4

8. References

• Schedule M – Good Manufacturing Practices
• WHO TRS No. 986 Annex 2: GMP for Pharmaceutical Products
• Internal SOP for Vendor Qualification

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Raw Material Receipt Register

Log sheet to record material name, vendor, batch number, GRN number, quantity, and receipt date.

Annexure-2: Sampling Request Form

Request raised to QC for sampling and testing of materials with traceability info.

Annexure-3: Material Rejection Note

QA-issued document for rejected lots including reason for rejection and final disposition.

Annexure-4: Material Dispensing Register

Record of all materials issued to gel manufacturing along with batch number and quantity dispensed.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/05/2022	1.0	Initial version	Initial implementation	QA Head
02/06/2025	2.0	Updated ERP linkage and rejection flow	System Integration & GMP	QA Head