To ensure compliance, review reports, and approve the analytical outcomes.

4. Accountability

Head – Gel Manufacturing and Head – Quality Assurance are accountable for the proper implementation and adherence to this SOP.

5. Procedure

5.1 Planning of Analytical Studies

1. Prepare an Analytical Study Protocol specifying the objectives, tests to be performed, acceptance criteria, and methods of analysis.
2. Get protocol reviewed and approved by QA before starting any analysis.
3. Ensure analytical methods are validated or verified before use.

5.2 Sampling Procedure

1. Draw development batch samples as per approved sampling plan from designated containers.
2. Label samples with formulation code, batch number, and date of sampling.
3. Maintain traceability by recording in the Development Batch Sampling Register.

5.3 Conducting Analytical Tests

1. Perform tests such as:
   • Appearance
   • pH
   • Viscosity
   • Drug content (Assay)
   • Microbial load
   • Stability (initial, accelerated, real-time)
   • Rheological properties
   • Drug release/diffusion profile
2. Follow pharmacopeial methods (IP, USP, Ph. Eur.) or approved in-house methods.
3. Document each test in the Analytical Study Data Sheet (Annexure-1).

5.4 Data Review and Interpretation

1. Review analytical results against specifications defined in the protocol.
2. Identify trends, anomalies, or deviations and investigate as per deviation SOP if required.
3. Summarize findings in the Analytical Summary Report (Annexure-2).

5.5 Stability and Compatibility Testing

1. Subject samples to different temperature and humidity conditions (e.g., 25°C/60%RH, 40°C/75%RH).
2. Assess physical appearance, pH, assay, and microbial content at defined intervals.
3. Perform packaging compatibility studies using proposed container closure systems.

5.6 Report Preparation

1. Compile analytical data and interpretation in the Development Report (Annexure-3).
2. Ensure QA review and approval of all final reports before conclusion of development stage.

6. Abbreviations

• QA: Quality Assurance
• QC: Quality Control
• RH: Relative Humidity
• IP: Indian Pharmacopoeia
• USP: United States Pharmacopeia
• Ph. Eur.: European Pharmacopoeia

7. Documents

1. Analytical Study Data Sheet – Annexure-1
2. Analytical Summary Report – Annexure-2
3. Development Report Template – Annexure-3

8. References

• ICH Q8 – Pharmaceutical Development
• WHO Technical Report Series on Pharmaceutical Product Development
• Internal Development and Analytical SOPs

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	R&D Scientist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Analytical Study Data Sheet

Test	Method	Specification	Result	Remarks
pH	USP <791>	5.5 – 6.5
Viscosity	Brookfield Viscometer	10,000 – 30,000 cP
Assay	HPLC	95% – 105%

Annexure-2: Analytical Summary Report

Formulation Code
Batch No.
Date of Analysis
Summary of Findings
Conclusion
Reviewed By (QA)

Annexure-3: Development Report Template

Title	Analytical Evaluation of Gel Formulation
Objective	To evaluate and finalize the analytical profile of the test formulation
Summary of Tests Conducted
Final Conclusion
Prepared By
Approved By

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
05/05/2022	1.0	Initial version	New Document	QA Manager
09/06/2025	2.0	Updated testing methods and annexure formats	Regulatory compliance	QA Manager