Standard Operating Procedure for Wet Granulation

1) Purpose

The purpose of this SOP is to provide guidelines for the wet granulation process in pharmaceutical manufacturing, ensuring uniform and reproducible granule formation.

2) Scope

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

3) Responsibilities

Production Operator: Responsible for conducting wet granulation and following SOPs.
Quality Control (QC) Analyst: Responsible for monitoring granulation parameters and conducting quality checks.

4) Procedure

1. Preparation Before Granulation:
   1. Verify cleanliness and operational status of the granulator.
   2. Prepare granulation solution as per formulation requirements.
2. Granulation Process:
   1. Charge the dry powder blend into the granulator.
   2. Add the granulation solution slowly while mixing to form wet mass.
   3. Continue mixing until homogeneous wet mass is achieved.
3. Wet Massing and Drying:
   1. Extrude or sieve the wet mass to obtain granules of desired size.
   2. Dry the wet granules in a suitable drying equipment until the desired moisture content is achieved.
4. Sizing and Inspection:
   1. Sieve the dried granules to achieve uniform particle size distribution.
   2. Inspect granules for size, shape, and uniformity.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control

6) Documents, if any

Batch Records, Granulation Logs, Quality Inspection Reports

7) Reference, if any

Pharmacopoeial guidelines (e.g., USP, EP) for wet granulation in pharmaceutical manufacturing.

8) SOP Version

Version 1.0