Standard Operating Procedure for Granulation Endpoint Determination

1) Purpose

The purpose of this SOP is to provide guidelines for determining the endpoint of granulation process in pharmaceutical manufacturing, ensuring consistency and quality of granulated products.

2) Scope

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

3) Responsibilities

Production Operator: Responsible for monitoring and determining the granulation endpoint.
Quality Control (QC) Analyst: Responsible for testing and verifying granulation endpoint parameters.

4) Procedure

1. Sampling and Testing:
   1. Collect samples at specified time intervals during the granulation process.
   2. Perform tests such as particle size distribution, moisture content, and flowability.
2. Endpoint Determination Criteria:
   1. Monitor the granule size distribution to achieve desired particle size parameters.
   2. Ensure moisture content is within specified limits for optimal granulation.
   3. Evaluate granule flowability to meet processing requirements.
3. Documentation:
   1. Record observations and test results at each sampling point.
   2. Document the determined endpoint based on predefined criteria.
4. Quality Assurance Check:
   1. Review granulation endpoint data and documentation for accuracy and completeness.
   2. Approve the endpoint determination before proceeding to the next manufacturing step.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control

6) Documents, if any

Granulation Batch Records, Testing Reports, Endpoint Determination Logs

7) Reference, if any

Pharmacopoeial guidelines (e.g., USP, EP) for granulation processes.

8) SOP Version

Version 1.0