Standard Operating Procedure for Preventing Contamination in Granules Production

1) Purpose

The purpose of this SOP is to establish procedures to prevent contamination during granules production in the pharmaceutical industry, ensuring product quality and safety.

2) Scope

This SOP applies to all personnel involved in granules production processes within the pharmaceutical manufacturing facility.

3) Responsibilities

Production Supervisors: Responsible for implementing contamination prevention measures.
Quality Assurance (QA) Department: Responsible for monitoring and auditing contamination control procedures.
Operators and Technicians: Responsible for adhering to contamination prevention protocols during operations.

4) Procedure

1. Facility Design and Layout:
   1. Design production areas with separate zones for different process stages (e.g., raw material handling, processing, packaging).
   2. Implement controlled access and air handling systems to minimize contamination risks.
2. Personnel Hygiene:
   1. Enforce strict gowning and hygiene practices for personnel entering production areas.
   2. Provide training on contamination prevention and aseptic techniques.
3. Equipment Cleaning and Maintenance:
   1. Develop and follow cleaning procedures for equipment used in granules production.
   2. Regularly inspect and maintain equipment to prevent contamination risks.
4. Material Handling:
   1. Store and handle raw materials in a manner that prevents contamination.
   2. Use dedicated tools and equipment for each material to prevent cross-contamination.
5. Environmental Monitoring:
   1. Conduct regular monitoring of air quality, particulate levels, and microbial contamination in production areas.
   2. Take corrective actions based on monitoring results to maintain cleanliness and prevent contamination.
6. Documentation and Records:
   1. Maintain comprehensive records of contamination prevention activities, including cleaning logs and environmental monitoring reports.
   2. Review and update procedures based on audit findings and regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance

6) Documents, if any

Cleaning Procedures, Facility Layout Plans, Contamination Control Logs

7) Reference, if any

Good Manufacturing Practice (GMP) guidelines for pharmaceutical manufacturing.

8) SOP Version

Version 1.0