Standard Operating Procedure for Process Optimization for Granules

1) Purpose

The purpose of this SOP is to outline the procedures for process optimization of granule manufacturing in the pharmaceutical industry to enhance efficiency, consistency, and product quality.

2) Scope

This SOP applies to all personnel involved in the process optimization activities for granule manufacturing within the pharmaceutical production and quality control departments.

3) Responsibilities

Production Department: Responsible for identifying and implementing process optimization opportunities.
Quality Control (QC) Department: Responsible for monitoring and validating optimized processes.
Engineering Department: Responsible for supporting technical changes and equipment modifications during optimization.

4) Procedure

1. Initial Assessment:
   1. Review current manufacturing processes and identify areas for potential improvement.
   2. Collect baseline data on process performance and product quality.
2. Planning:
   1. Develop a process optimization plan, including objectives, timelines, and resource requirements.
   2. Define key performance indicators (KPIs) to measure the success of optimization efforts.
3. Implementation:
   1. Implement changes in the manufacturing process according to the optimization plan.
   2. Train personnel on new procedures and changes in the process.
   3. Adjust equipment settings and process parameters as needed.
4. Monitoring and Data Collection:
   1. Monitor the optimized process continuously to ensure it meets the desired performance and quality standards.
   2. Collect data on process variables and product attributes regularly.
5. Analysis and Review:
   1. Analyze collected data to evaluate the effectiveness of the optimization.
   2. Compare new process