M guidelines.

2. Scope

This SOP applies to all personnel involved in the dispensing of raw materials, APIs, preservatives, and excipients for gel formulations at the pharmaceutical manufacturing site.

3. Responsibilities

• Dispensing Chemist: Responsible for real-time, legible, and complete entries in all dispensing records.
• Quality Assurance (QA): Responsible for reviewing and verifying the documentation for completeness, accuracy, and compliance.
• Production Supervisor: Responsible for overseeing the dispensing operations and ensuring documentation is maintained as per SOP.

4. Accountability

The Head – Quality Assurance is accountable for implementation, training, and periodic review of this SOP.

5. Procedure

5.1 General Documentation Requirements

1. All records must be completed in blue ink and must be clear, legible, and without overwriting.
2. Each entry must include date, time (24-hour format), signature/initials, and employee code wherever applicable.
3. Any correction should be done by striking a single line through the incorrect entry, making the correct entry alongside, and providing initials, date, and reason for correction.

5.2 Specific Documents to be Maintained

• Dispensing Logbook: Must include material name, batch number, quantity dispensed, date, time, operator name, and checker details.
• Material Reconciliation Form: For each batch, input vs. output and wastage calculations should be documented and signed.
• Material Status Tag: Applied to each dispensed material container with details like dispensed by, checked by, quantity, and date.

5.3 Batch Manufacturing Record (BMR)

1. All dispensing details should be transcribed to the BMR, including weights, material codes, lot numbers, and verification signatures.
2. The BMR must be updated in real time, during or immediately after completion of dispensing activity.
3. Review of the BMR must be completed by QA before the next stage of manufacturing is initiated.

5.4 Handling Deviations in Documentation

1. In case of any documentation error or deviation, inform QA immediately and fill a deviation form (Annexure-3).
2. Attach copies of supporting documentation and submit to QA for review and CAPA (Corrective and Preventive Action).

5.5 Archival of Records

• Completed dispensing records must be compiled, signed off by QA, and sent to the Document Control Cell (DCC) within 3 working days.
• All records shall be retained for a period of 5 years from date of batch release.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• DCC: Document Control Cell
• CAPA: Corrective and Preventive Action

7. Documents

1. Dispensing Logbook – Annexure-1
2. Material Reconciliation Sheet – Annexure-2
3. Deviation Report Form – Annexure-3

8. References

• WHO TRS 986 – Annex 2: Good manufacturing practices
• Schedule M: Good Manufacturing Practices and Requirements of Premises
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients

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: Dispensing Logbook

Date	Material Name	Batch No	Qty	Operator	Checked By
02/06/2025	Carbomer 940	GM202501	12.5 kg	OP123	QA456

Annexure-2: Material Reconciliation Sheet

Material	Qty Issued	Qty Used	Wastage	Remarks
Triethanolamine	2.0 kg	1.95 kg	0.05 kg	Wiped off

Annexure-3: Deviation Report Form

Deviation No	Description	Corrective Action	Preventive Action	QA Review
DVN-GM-001	Missed entry in logbook	Entry updated	Double-check logbook before shift end	Reviewed

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2022	1.0	Initial Issue	First SOP Release	QA Head
02/06/2025	2.0	Updated documentation workflow	GMP enhancement	QA Head