protocol.

QA Executive: Ensures compliance to regulatory requirements, line clearance, and in-process quality checks.

Clinical Project Manager: Coordinates trial-related documentation and labeling approval.

4. Accountability

The Head – Manufacturing is accountable for the implementation of this SOP and for ensuring that all preparations for clinical trial batches meet regulatory expectations.

5. Procedure

5.1 Pre-Requisites

1. Obtain approved Clinical Trial Application (CTA) or IND approval from the sponsor/regulatory body.
2. Ensure availability of approved protocol, batch manufacturing record (BMR), and trial-specific documents.
3. Verify raw materials, APIs, and excipients are approved for clinical use and accompanied by COA.

5.2 Facility Preparation

1. Clean and sanitize designated clinical trial manufacturing area as per SOP/GM/055/2025.
2. Perform line clearance and document in Annexure-1.

5.3 Equipment Preparation

1. Use dedicated or qualified equipment (homogenizers, gel mixers, filling lines) and calibrate prior to use.
2. Record calibration logs and cleaning activities in Annexure-2.

5.4 Gel Manufacturing Process

1. Follow the approved BMR and formulation protocol for ingredient addition, temperature, mixing speed, and time.
2. Use precision balances for weighing micro quantities of actives.
3. Maintain batch homogeneity and document in-process checks (pH, viscosity, appearance).

5.5 Sampling and Testing

1. Collect samples for QC testing as per sampling SOP/QC/010/2025.
2. QC tests to include:
   • Appearance, pH, viscosity
   • Drug content uniformity
   • Microbial limit testing
   • Preservative efficacy (if applicable)
3. Release gel formulation only upon QA approval.

5.6 Labeling and Packaging

1. Use trial-specific pre-approved labels bearing Trial ID, Protocol Code, Batch No., Expiry, Storage Conditions.
2. Perform secondary packaging as per clinical supply SOP and store in quarantine area until dispatch.

5.7 Documentation

1. Maintain trial batch BMR with traceability of each step.
2. Attach certificates of analysis, formulation development reports, deviation reports (if any).
3. Retain records as per ICH GCP guidelines for minimum 5 years post-trial completion.

6. Abbreviations

• GMP: Good Manufacturing Practice
• GCP: Good Clinical Practice
• BMR: Batch Manufacturing Record
• COA: Certificate of Analysis
• QA: Quality Assurance

7. Documents

1. Line Clearance Record – Annexure-1
2. Equipment Preparation Log – Annexure-2
3. Clinical Trial Batch BMR – Annexure-3
4. QC Report – Annexure-4
5. Clinical Label Reconciliation Sheet – Annexure-5

8. References

• ICH E6(R2) – Good Clinical Practice Guidelines
• Schedule Y – Drugs and Cosmetics Act, India
• FDA 21 CFR Part 312 – Investigational New Drug Application

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: Line Clearance Record

Date	Area Name	Cleared By	QA Verified	Remarks

Annexure-2: Equipment Preparation Log

Equipment ID	Cleaning Done By	Calibration Date	Status

Annexure-3: Clinical Trial Batch BMR

(Attach scanned BMR pages or maintain digitally as per ALCOA+ principles)

Annexure-4: QC Report

Test	Specification	Result	Status

Annexure-5: Clinical Label Reconciliation Sheet

Label ID	Issued	Used	Destroyed	Balance

Revision History

Revision Date	Revision No.	Description of Change	Reason	Approved By
03/05/2022	1.0	Initial draft release	New clinical SOP	QA Head
09/06/2025	2.0	Updated with trial labeling and documentation sections	Process optimization	QA Head