and WHO guidelines.

2. Scope

This SOP applies to all operations involving excipients used in the production of topical gel formulations, including but not limited to carbomers, glycerin, PEGs, sorbitol, and preservatives within the Gel Manufacturing Department.

3. Responsibilities

• Dispensing Operator: Handles and weighs excipients as per approved procedures.
• Warehouse Assistant: Ensures materials are transferred properly with supporting documents.
• Production Supervisor: Verifies material identity and quantity, signs weighing logs.
• QA Officer: Conducts clearance, verifies documentation, and approves dispensed material.

4. Accountability

The Head of Manufacturing is accountable for ensuring proper control, accuracy, and traceability of excipient dispensing in line with quality and regulatory standards.

5. Procedure

5.1 Receipt and Storage of Excipients

1. Receive excipients in the warehouse based on approved purchase orders and specifications.
2. Ensure QA clearance is obtained and CoA is available for each batch.
3. Store excipients in designated areas with proper segregation and temperature/humidity monitoring.

5.2 Preparation for Dispensing

1. Verify environmental conditions in the dispensing area (temperature: 20–25°C, RH: ≤ 60%).
2. Ensure balances are calibrated and cleaned prior to use.
3. Use clean scoops, containers, and PPE as per SOP for personal hygiene and equipment handling.

5.3 Dispensing of Excipients

1. Verify the excipient name, code, batch number, and expiry date against the material requisition form.
2. Weigh each excipient as per the Bill of Materials (BOM) listed in the Batch Manufacturing Record (BMR).
3. Record exact quantity weighed in the Excipient Dispensing Log (Annexure-1).
4. Limit exposure time for hygroscopic or sensitive excipients; cover the containers immediately after weighing.

5.4 Labeling and Identification

1. Affix a “Dispensed” label on each container with the following:
   • Material Name and Code
   • Batch Number
   • Quantity Dispensed
   • Date
   • Signature of Operator and Verifier

5.5 Cross-Verification and Approval

1. Production Supervisor verifies:
   • Weighed quantity vs BOM
   • Label information
   • Material integrity
2. QA Officer verifies entries and stamps the Excipient Release Form (Annexure-2).

5.6 Documentation

1. Attach the dispensing log, CoA, and release form with the BMR.
2. All records must be signed, dated, and free from overwriting. If any error is made, strike through once and correct with justification and initials.
3. Maintain records for 5 years or as per retention policy.

5.7 Handling of Rejected or Expired Excipients

1. Immediately label any suspected or expired material as “Rejected – Do Not Use”.
2. Segregate and quarantine such materials in a designated rejection area.
3. Initiate Material Disposition Form (Annexure-3) for disposal or reprocessing decision by QA.

6. Abbreviations

• SOP: Standard Operating Procedure
• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• CoA: Certificate of Analysis

7. Documents

1. Excipient Dispensing Log – Annexure-1
2. Excipient Release Form – Annexure-2
3. Material Disposition Form – Annexure-3

8. References

• WHO GMP Guidelines – TRS 986
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• Schedule M – Indian GMP Guidelines

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: Excipient Dispensing Log

Date	Material	Batch No.	Quantity	Weighed By
02/06/2025	Glycerin	GLY0525	10 kg	Rajesh Kumar

Annexure-2: Excipient Release Form

Material	Glycerin
Batch No.	GLY0525
Released By	QA Officer
Date	02/06/2025

Annexure-3: Material Disposition Form

Material	Batch No.	Issue	Disposition	Approved By
PEG 400	PEG0524	Expired	To be discarded	QA Manager

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	New SOP	QA Head
02/06/2025	2.0	Updated handling and documentation procedures	Annual Review	QA Head