Gel Manufacturing: SOP for Documentation Practices in Gel Manufacturing – V 2.0

Standard Operating Procedure for Documentation Practices in Gel Manufacturing

Department	Gel Manufacturing
SOP No.	SOP/GM/179/2025
Supersedes	SOP/GM/179/2022
Page No.	Page 1 of 9
Issue Date	09/06/2025
Effective Date	11/06/2025
Review Date	09/06/2027

1. Purpose

To define standard documentation practices for recording, reviewing, and managing manufacturing data related to gel production to ensure traceability, regulatory compliance, and data integrity.

2. Scope

This SOP is applicable to all personnel involved in documenting activities related to manufacturing, cleaning, calibration, and material handling in the Gel Manufacturing Department.

3. Responsibilities

Operators: Record real-time data accurately and legibly.
Supervisors: Review entries for correctness and completeness.
QA Personnel: Verify documentation compliance and approve batch-related documents.

4. Accountability

The Head of Manufacturing is accountable for ensuring adherence to documentation procedures and regulatory expectations.

5. Procedure

5.1 General Documentation

Guidelines

All entries must be made in indelible ink (preferably blue).
Entries must be legible, accurate, and made in real-time.
Never use correction fluid or erase data. Use a single line to strike through incorrect data and sign/date adjacent.
Ensure all fields, including initials, date, and time, are duly filled where required.

5.2 Recording in Batch Manufacturing Record (BMR)

Record each stage of gel production — material verification, dispensing, processing, filling, and cleaning.
Document process parameters like temperature, speed (RPM), time, batch size, and pH where applicable.
Record equipment ID and calibration status.
Attach supporting forms and checklists as Annexures to the BMR.

5.3 Logbook Management

Maintain separate logbooks for equipment usage, cleaning, maintenance, and calibration.
Logbooks should be bound with pre-numbered pages.
Entries must include date, time, activity performed, signature, and initials.
Retain filled logbooks in secure storage for 5 years or as per regulatory policy.

5.4 Controlled Documents Handling

Only use QA-issued controlled documents with current version number.
Do not photocopy or duplicate without authorization.
Obsolete documents should be stamped “OBSOLETE” and archived as per QA SOP.

5.5 Deviations and Corrections

Record all deviations and notify QA immediately using the Deviation Report Form (Annexure-3).
Corrected entries must be signed, dated, and justified in the remarks section.

6. Abbreviations

BMR: Batch Manufacturing Record
QA: Quality Assurance
GMP: Good Manufacturing Practice

7. Documents

Batch Manufacturing Record Template – Annexure-1
Logbook Format for Equipment Usage – Annexure-2
Deviation Report Form – Annexure-3
Document Control Log – Annexure-4

8. References

WHO TRS 996: Annex 7 – Good Documentation Practices
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
SOP/QA/010/2025 – Document Control Procedure

9. SOP Version

Version: 2.0

10. Approval Section

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

11. Annexures

Annexure-1: BMR Template

Step	Parameter	Observation	Date	Signature
Material Dispensing	Lot No., Qty
Mixing	RPM, Time
Filling	Batch Size

Annexure-2: Equipment Logbook Format

Date	Equipment ID	Activity	Operator	Remarks

Annexure-3: Deviation Report Form

Deviation ID	Date	Description	Corrective Action	QA Approval

Annexure-4: Document Control Log

Document Name	Version	Issue Date	Status	Location

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
10/04/2022	1.0	Initial version	New SOP	QA Head
09/06/2025	2.0	Expanded logbook practices and annexures	Audit compliance	QA Head