R&D or pilot manufacturing units of the pharmaceutical plant.

3. Responsibilities

• Formulation Scientist: Responsible for initiating and designing the formulation experiments.
• Formulation Manager: Reviews trial results and authorizes progression to the next stage.
• Quality Assurance: Ensures compliance with formulation design procedures and maintains records.

4. Accountability

The Head – Gel Manufacturing and Head – R&D are accountable for the accuracy, scientific soundness, and regulatory compliance of gel formulation development procedures.

5. Procedure

5.1 Initial Literature Review and Conceptualization

1. Review pharmacopoeias, scientific journals, and product monographs for target formulation attributes.
2. Identify therapeutic category, route of administration (e.g., topical, transdermal), and required release profile.
3. Consult regulatory guidelines for target markets (e.g., CDSCO, USFDA, EMA).

5.2 Selection of API

1. Confirm API identity, assay, solubility profile, and compatibility with excipients.
2. Perform preliminary studies to assess photostability, thermal stability, and pKa behavior in aqueous/gel bases.

5.3 Selection of Gelling Agents and Excipients

1. Choose appropriate gelling agents (e.g., Carbopol, HPMC, Poloxamer) based on viscosity range and target application.
2. Select solvents (e.g., water, ethanol, propylene glycol) and co-solvents based on API solubility.
3. Choose preservatives and stabilizers per antimicrobial effectiveness and regulatory acceptability.

5.4 Trial Formulation Design

1. Create 3 to 5 formulation prototypes varying gelling agents, solvent systems, and concentrations.
2. Document each trial in the Formulation Design Record (Annexure-1).
3. Ensure each prototype is coded and labeled with date, batch number, and formulation reference.

5.5 Evaluation Parameters

1. Evaluate appearance, color, clarity, pH, viscosity, and homogeneity.
2. Conduct spreadability and wash-off studies using defined mechanical methods.
3. Conduct preliminary compatibility testing using FTIR or DSC with selected excipients.

5.6 Stability of Formulations

1. Perform accelerated and ambient stability tests for shortlisted prototypes.
2. Check phase separation, syneresis, and microbial growth during 1-week and 1-month periods.

5.7 Finalization of Optimized Formula

1. Select the prototype with the best results in terms of physical stability, spreadability, drug content, and organoleptic characteristics.
2. Transfer formulation to scale-up lab for further optimization using SOP/GM/015/2025.

6. Abbreviations

• API: Active Pharmaceutical Ingredient
• DSC: Differential Scanning Calorimetry
• FTIR: Fourier-Transform Infrared Spectroscopy
• SOP: Standard Operating Procedure

7. Documents

1. Formulation Design Record – Annexure-1
2. Stability Observation Template – Annexure-2
3. Formulation Review Checklist – Annexure-3

8. References

• ICH Q8(R2): Pharmaceutical Development
• USP 43 – General Chapters for Semisolid Dosage Forms
• Schedule M – Indian GMP Guidelines

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: Formulation Design Record

Prototype Code	Gelling Agent	Solvent System	Preservative	Notes
F01	Carbopol 940	Water:Glycerin	Methylparaben	Transparent, stable

Annexure-2: Stability Observation Template

Prototype	Day 1	Day 7	Day 30	Remarks
F01	Clear	No Change	Stable	Approved for scale-up

Annexure-3: Formulation Review Checklist

• API compatibility confirmed: Yes/No
• Viscosity within range: Yes/No
• Spreadability acceptable: Yes/No
• Appearance acceptable: Yes/No
• QA approval obtained: Yes/No

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
02/06/2022	1.0	Initial version	New SOP	QA Head
02/06/2025	2.0	Added new formulation screening steps and review annexures	Process improvement	QA Head