Standard Operating Procedure for Milling Process in Granules Production

1) Purpose

The purpose of this SOP is to provide guidelines for the milling process in granules production within the pharmaceutical industry, ensuring uniform particle size reduction and maintaining product quality.

2) Scope

This SOP applies to all personnel involved in the milling operations of granules within the pharmaceutical manufacturing department.

3) Responsibilities

Production Operator: Responsible for operating milling equipment and following SOPs.
Quality Control (QC) Analyst: Responsible for monitoring milled granules for quality attributes.

4) Procedure

1. Preparation Before Milling:
   1. Verify cleanliness and operational status of milling equipment.
   2. Set milling parameters based on batch specifications and approved procedures.
2. Milling Process:
   1. Load granules into the milling equipment according to batch records.
   2. Start milling process with predefined parameters (e.g., speed, sieve size).
   3. Monitor milling progress to ensure uniform particle size reduction.
3. Post-Milling Quality Checks:
   1. Collect samples after milling completion.
   2. Perform particle size distribution analysis to verify uniformity.
   3. Check for any contamination or defects.
4. Cleaning and Maintenance:
   1. Clean milling equipment thoroughly after use to prevent cross-contamination.
   2. Perform routine maintenance as per equipment manufacturer’s guidelines.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control

6) Documents, if any

Batch Records, Milling Logs, Particle Size Distribution Reports

7) Reference, if any

Pharmacopoeial guidelines (e.g., USP, EP) for milling of pharmaceutical granules.

8) SOP Version

Version 1.0