products conducted in the Gel Manufacturing Department, including manual and electronic record-keeping systems.

3. Responsibilities

• Production Operator: Responsible for accurately documenting each dispensing step.
• Production Supervisor: Verifies the correctness and completeness of documentation.
• QA Officer: Reviews and archives the records and ensures data integrity.

4. Accountability

The Head – Gel Manufacturing and Head – Quality Assurance are accountable for the overall implementation, review, and maintenance of this SOP and the related records.

5. Procedure

5.1 General Requirements

1. All entries must be made using permanent blue or black ink.
2. No overwriting is allowed. If corrections are needed, strike through the original entry with a single line, sign, date, and provide a reason.
3. Each record must be reviewed and signed by both operator and supervisor.

5.2 Logbook Maintenance

1. Maintain a separate dispensing logbook for each gel formulation batch.
2. Each logbook must have a unique ID linked to the Batch Manufacturing Record (BMR).
3. Enter the following data in the dispensing log:
   • Batch number
   • Product name
   • Date and time of dispensing
   • Material name and code
   • Weighed quantity
   • Container ID
   • Balance ID used
   • Initials of operator and verifier

5.3 Material Reconciliation

1. Ensure that all dispensed quantities match the material requisition sheet.
2. Document any deviation or shortage with justification and inform QA immediately.

5.4 Label Documentation

1. Each dispensed material should be affixed with a “Dispensed” label (Annexure-1).
2. Ensure all details are handwritten clearly and match the logbook entries.

5.5 Electronic Record Maintenance (if applicable)

1. Login using authorized credentials only.
2. Ensure digital time stamps and audit trails are maintained.
3. Backup data at the end of each shift and store it on the validated server as per IT SOPs.

5.6 Record Retention and Archiving

1. Store physical records in fireproof and humidity-controlled storage rooms.
2. Retain all dispensing records for a minimum of 5 years or as per regulatory requirements.

6. Abbreviations

• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• ID: Identification

7. Documents

1. Dispensing Logbook – Annexure-2
2. Dispensed Material Label – Annexure-1
3. Material Reconciliation Sheet – Annexure-3

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO TRS 986 – Annex 2
• 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: Dispensed Material Label Format

Material Name
Batch No.
Quantity Dispensed
Date
Dispensed By
Verified By

Annexure-2: Sample Page from Dispensing Logbook

Material	Batch No.	Quantity	Date	Balance ID	Operator	Verifier
Carbopol 980	CB9800525	6.0 kg	02/06/2025	BL/203	Operator Initials	QA Initials

Annexure-3: Material Reconciliation Sheet

Material Name	Issued Qty	Used Qty	Balance	Remarks
Triethanolamine	3.0 kg	2.95 kg	0.05 kg	Returned to store

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
02/06/2022	1.0	Initial Issue	New SOP	QA Head
02/06/2025	2.0	Integrated electronic documentation guidelines	Regulatory Update	QA Head