coatings, while the QA Manager is responsible for ensuring compliance with regulatory guidelines and internal quality standards.

5. Procedure

5.1 Identifying Requirements for Coating

Ensure that the functional requirements for the capsule coating are clearly defined:

1. Coating Functionality
   1. Determine the primary function of the coating (e.g., immediate release, delayed release, or controlled release).
   2. Consider the stability, protection, and aesthetic requirements of the coating, such as color, gloss, and texture.
2. API Compatibility
   1. Assess the compatibility of the API with the polymer options to ensure that no degradation, interaction, or instability occurs during the coating process.

5.2 Selecting Suitable Polymers

Screen and select polymers based on the defined coating requirements:

1. Polymer Types
   1. Choose polymers based on their release characteristics, such as natural and synthetic polymers for different types of coating (e.g., HPMC for controlled release, Eudragit for enteric coatings).
   2. Consider the polymer’s solubility in water, pH sensitivity, and ability to form a uniform coating film on the capsule.
2. Polymer Functional Properties
   1. Assess the properties of the polymer such as viscosity, film-forming capability, and ability to protect the API from moisture or light.
   2. Consider the ease of application, including sprayability and the drying process of the polymer when used in coating equipment.

5.3 Conducting Polymer Testing

Test selected polymers for performance and compatibility with capsule formulations:

1. Film Formation Test
   1. Test the polymer’s ability to form a smooth and uniform coating on the capsule using a film-forming test.
   2. Evaluate the appearance, smoothness, and uniformity of the coating under visual inspection and microscopy.
2. Dissolution Testing
   1. Conduct dissolution tests on capsules coated with the selected polymers to evaluate the release profile of the API.
   2. Monitor the release rate and compare the results against the desired specifications for immediate or controlled release.
3. Stability Testing
   1. Conduct accelerated and long-term stability testing on the coated capsules to assess the effect of the coating on the stability of the API under various storage conditions (temperature, humidity, etc.).
   2. Ensure that the polymer maintains the integrity of the capsule coating during the shelf life of the product.
4. Compatibility Study
   1. Perform compatibility studies between the polymer and excipients used in the capsule fill to ensure there are no adverse interactions or instability in the final product.

5.4 Optimizing Polymer Formulation

Optimize the formulation of the polymer coating based on the testing results:

1. Polymer Concentration
   1. Adjust the concentration of the selected polymer to achieve the desired coating thickness and performance.
   2. Ensure that the polymer solution or dispersion is uniform and free of particles that could affect the application process.
2. Plasticizer Selection
   1. Select appropriate plasticizers to improve the flexibility and workability of the polymer coating, preventing cracking or peeling.
   2. Test different plasticizers to determine the optimal combination for a flexible and durable coating.
3. Coating Process Parameters
   1. Optimize the coating process parameters such as spray rate, drying temperature, and spray distance to ensure consistent coating quality.
   2. Ensure that the coating process is scalable for large-scale manufacturing while maintaining product quality.

5.5 Final Evaluation and Selection of Polymer

Evaluate the final selection of the polymer based on all testing results:

1. Final Testing
   1. Conduct final dissolution and stability tests on the polymer-coated capsules to ensure that the formulation meets all quality specifications for release and stability.
   2. Confirm that the coating provides the required functionality such as controlled release or enteric protection.
2. Polymer Approval
   1. Approve the selected polymer based on the results of all testing and evaluation, ensuring it meets regulatory standards and performance specifications.

5.6 Documentation and Record-Keeping

Ensure proper documentation of the polymer screening and selection process:

1. Documentation of Polymer Selection
   1. Document all polymer screening, testing, and evaluation results in a detailed report that includes the selected polymer, the testing methods used, and the final recommendations.
   2. Ensure that all documentation is reviewed and signed off by the formulation team and the QA team.
2. Record Retention
   1. Ensure that all records, including test data, approval forms, and any deviations, are securely stored for future reference and regulatory audits.

6. Abbreviations

• SOP: Standard Operating Procedure
• API: Active Pharmaceutical Ingredient
• QA: Quality Assurance
• QC: Quality Control
• GMP: Good Manufacturing Practice
• HPLC: High-Performance Liquid Chromatography
• FTIR: Fourier Transform Infrared Spectroscopy
• DSC: Differential Scanning Calorimetry

7. Documents

1. Polymer Screening Report (Annexure-1)
2. Polymer Compatibility Study (Annexure-2)
3. Polymer Coating Test Results (Annexure-3)

8. References

• USP <711> – Dissolution Testing
• ICH Q1A (R2) – Stability Testing of New Drug Substances and Products
• FDA Guidance for Industry: Capsule Coating

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Polymer Screening Report

Date	Polymer Name	Study Type	Result
03/02/2025	Polymer-123	Compatibility Test	Stable with API

Annexure-2: Polymer Compatibility Study

Polymer-123

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Date	Polymer	API	Test Method	Outcome
04/02/2025	API-456	DSC	No incompatibility

Annexure-3: Polymer Coating Test Results

Date	Test Type	Result	Action Taken
05/02/2025	Dissolution Test	Pass	Formulation approved

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated polymer selection process	Standardization	QA Head