SOP Guide for Pharma

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

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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.

See also  Gel Manufacturing: SOP for Evaluating API Compatibility in Gels - V 2.0

5. Procedure

5.1 General Documentation

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

5.2 Recording in Batch Manufacturing Record (BMR)

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

5.3 Logbook Management

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

5.4 Controlled Documents Handling

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

5.5 Deviations and Corrections

  1. Record all deviations and notify QA immediately using the Deviation Report Form (Annexure-3).
  2. 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

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