1) SOP for Granulation Process

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide detailed guidelines for the granulation process, including equipment setup, process parameters, and batch documentation, to ensure uniform granules in pharmaceutical production.

3) Scope

This SOP applies to all personnel involved in the granulation process within the pharmaceutical manufacturing area.

4) Responsibilities

• Operators are responsible for setting up the granulation equipment and executing the process according to this SOP.
• Supervisors are responsible for overseeing the process and ensuring compliance.
• Quality Assurance (QA) personnel are responsible for verifying that procedures are followed correctly.

5) Procedure

1. Preparation
   1. Ensure the granulation area is clean and free of contaminants.
   2. Verify the availability and quality of raw materials as per the batch record.
   3. Check the cleanliness and readiness of the granulation equipment.
2. Equipment Setup
   1. Assemble the granulator according to the manufacturer’s instructions.
   2. Verify that all components are securely in place.
   3. Set the granulator parameters (e.g., speed, time) according to the batch record.
3. Granulation Process
   1. Load the raw materials into the granulator in the specified order.
   2. Start the granulator and monitor the process continuously.
   3. Ensure that the granulation time meets the specified duration.
   4. Regularly check for uniformity by sampling the granules at different intervals.
   5. Document any observations and adjustments made during the granulation process.
4. Discharge and Transfer
   1. Once granulation is complete, discharge the granules into the designated container.
   2. Verify the weight of the granules to ensure it matches the expected output.
   3. Transfer the granules to the next processing stage as per the production schedule.
5. Cleaning and Maintenance
   1. Turn off and disassemble the granulator according to the manufacturer’s instructions.
   2. Clean all parts thoroughly to prevent cross-contamination.
   3. Document the cleaning process in the cleaning logbook.

6) Abbreviations, if any

• SOP: Standard Operating Procedure
• QA: Quality Assurance

7) Documents, if any

• Batch Record
• Cleaning Logbook
• Maintenance Logbook

8) Reference, if any

• Current Good Manufacturing Practice (cGMP) guidelines
• Manufacturer’s operation and maintenance manual

9) SOP Version

Version 1.0