Standard Operating Procedure for Granulation in Capsule Formulations

Purpose

The purpose of this SOP is to establish procedures for the granulation process in the formulation of capsules, ensuring uniformity, consistency, and adherence to quality standards.

Scope

This SOP applies to all personnel involved in the capsule formulation process, including formulation scientists, operators, and quality assurance personnel.

Responsibilities

• Formulation Scientist: Responsible for developing the granulation process parameters.
• Operators: Responsible for executing the granulation process according to the established procedures.
• Quality Assurance: Responsible for monitoring and ensuring compliance with the granulation SOP.

Procedure

1. Review the formulation recipe to ensure that all required ingredients and their respective quantities are accurately documented.
2. Verify that all equipment, including granulators and drying equipment, is clean, sanitized, and calibrated before initiating the process.
3. Weigh and dispense each ingredient accurately, following Good Manufacturing Practices (GMP) and the approved formulation recipe.
4. Transfer the weighed ingredients to the granulator, following the specified order of addition and process parameters.
5. Initiate the granulation process, adjusting parameters such as impeller speed, binder addition rate, and granulation time as per the formulation requirements.
6. Monitor the granulation process to ensure the formation of granules with the desired characteristics, such as size, density, and moisture content.
7. Perform in-process checks, such as granule size analysis or moisture content determination, to assess the granulation’s quality during the process.
8. Upon completion of the granulation process, transfer the wet granules to the drying equipment and initiate the drying process under controlled conditions.
9. Monitor the drying process to achieve the specified moisture content in the granules, ensuring uniform drying and prevention of over-drying.
10. Perform final checks on the dried granules, including size analysis, moisture content, and visual inspection, to ensure compliance with specifications.
11. Document all relevant details, including start and end times, equipment used, and any deviations from the standard operating conditions.
12. Submit samples to the quality control laboratory for analysis, ensuring that the granules meet the predefined acceptance criteria.
13. If the granules pass quality control, proceed with further processing steps as per the formulation requirements.
14. If the granules fail quality control, initiate an investigation, document the findings, and implement corrective actions as needed.
15. Complete the batch record with all pertinent information, including any adjustments made during the granulation process.
16. Clean and sanitize the equipment thoroughly after each batch, following approved cleaning procedures.

Abbreviations

GMP: Good Manufacturing Practices

Documents

• Formulation Recipe
• Granulation Batch Record
• Quality Control Test Results
• Cleaning and Sanitization Records

Reference

ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

SOP Version

Version 1.0