Ensure uniformity in raw material lots or provide lot history for analysis.

4. Accountability

Head of Manufacturing is accountable for ensuring that the procedures outlined in this SOP are implemented and that production teams are trained accordingly.

5. Procedure

5.1 Raw Material Consistency

1. All raw materials must be sourced from approved vendors with validated specifications.
2. Lot-to-lot variability must be tracked through the raw material CoA and trending data.
3. If new lots are used, compatibility and equivalence testing must be conducted prior to use in production.

5.2 Equipment Calibration and Validation

1. Ensure all gel mixing, homogenizing, filling, and holding equipment are calibrated as per SOP/GM/136/2025.
2. Review equipment performance logs and validate uniformity of operation before each new batch.

5.3 In-Process Controls

1. Record critical process parameters (CPPs) such as:
   • Mixing time and RPM
   • Temperature at mixing and cooling stages
   • pH and viscosity range at key steps
2. Verify gel appearance, color, odor, and texture consistency with prior batches.
3. Cross-check values against the BMR and historical data for the same product.

5.4 Final Product Testing

1. Submit samples from the current batch and the last two batches for comparative testing.
2. Test for:
   • pH
   • Viscosity
   • Drug content
   • Microbial load
   • Appearance and homogeneity
3. QA to review reports and evaluate trend compliance. Any deviation >±10% must be investigated.

5.5 Documentation and Review

1. Complete batch manufacturing records (BMR) and attach process charts.
2. QA shall review the batch release checklist before final clearance.
3. Annual Product Review (APR) to capture any trends or outliers across batches.

6. Abbreviations

• BMR: Batch Manufacturing Record
• CPP: Critical Process Parameters
• QA: Quality Assurance
• QC: Quality Control
• APR: Annual Product Review

7. Documents

1. Batch Consistency Log – Annexure-1
2. Comparative Batch Testing Report – Annexure-2
3. Deviation and Change Control Register – Annexure-3

8. References

• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211 – Finished Pharmaceuticals
• SOP/GM/136/2025 – Equipment Calibration

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: Batch Consistency Log

Batch No.	Date	Product Code	Operator	Mixing Parameters	Remarks

Annexure-2: Comparative Batch Testing Report

Test	Previous Batch	Current Batch	Deviation (%)	Limit	Remarks
pH				±0.5
Viscosity				±10%
Drug Content				±5%

Annexure-3: Deviation and Change Control Register

Batch No.	Date	Description of Deviation	Corrective Action	QA Review

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
13/05/2022	1.0	Initial issue	New SOP	QA Head
09/06/2025	2.0	Added process controls and batch trending annexures	Annual review	QA Head