Standard Operating Procedure for Preventing Contamination in Gels Production

1) Purpose

The purpose of this SOP is to establish procedures for preventing contamination during the production of gels to ensure product quality, safety, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the manufacturing and handling of gels within the pharmaceutical manufacturing facility.

3) Responsibilities

Quality Control (QC) Manager: Oversee contamination prevention strategies and protocols.
Production Operators: Implement contamination control measures during gel production.
Cleaning and Maintenance Staff: Ensure cleanliness of equipment and facilities.

4) Procedure

4.1 Facility and Equipment Cleaning
4.1.1 Clean and sanitize manufacturing areas and equipment before and after each use.
4.1.2 Use validated cleaning procedures and appropriate disinfectants.

4.2 Personnel Hygiene
4.2.1 Follow strict hygiene practices including handwashing and proper gowning procedures.
4.2.2 Prohibit unauthorized personnel from entering production areas without appropriate PPE.

4.3 Material Handling and Storage
4.3.1 Store raw materials, intermediates, and finished products in designated areas.
4.3.2 Ensure proper labeling, segregation, and protection from contamination sources.

4.4 Environmental Monitoring
4.4.1 Conduct routine environmental monitoring for air quality and surface contamination.
4.4.2 Monitor personnel activities to minimize potential contamination risks.

4.5 Equipment Maintenance
4.5.1 Perform regular maintenance and calibration of equipment to prevent contamination.
4.5.2 Establish procedures for the cleaning and disinfection of equipment and utensils.

4.6 Contamination Control Measures
4.6.1 Implement procedures to address and mitigate contamination events promptly.
4.6.2 Conduct investigations and root cause analysis for any contamination incidents.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
PPE: Personal Protective Equipment

6) Documents, if any

– Cleaning and Sanitization Records
– Environmental Monitoring Reports
– Contamination Incident Reports

7) Reference, if any

– FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing
– EU GMP Annex 1: Manufacture of Sterile Medicinal Products
– Company-specific contamination control procedures

8) SOP Version

Version 1.0