Standard Operating Procedure for Water Testing

Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines and procedures for testing the microbial quality of water used in manufacturing processes within the pharmaceutical facility.

Scope

This SOP applies to all personnel involved in water testing procedures within the pharmaceutical manufacturing facility.

Responsibilities

• Quality Control (QC) Department: Responsible for overseeing the implementation and compliance of this SOP.
• Microbiologist: Responsible for performing water testing according to the procedures outlined in this SOP.
• Production Personnel: Responsible for collecting water samples and ensuring proper documentation.

Procedure

1. Sample Collection:
   • Collect water samples from designated sampling points using sterile containers.
   • Ensure proper labeling and identification of each sample.
2. Microbial Enumeration:
   • Perform microbial enumeration tests such as Total Viable Count (TVC) and Total Coliform Count (TCC) using appropriate culture media.
   • Inoculate the culture media with the water samples using aseptic techniques.
   • Incubate cultures under appropriate conditions for microbial growth.
   • Count microbial colonies and calculate the microbial load in colony-forming units per milliliter (CFU/ml).
3. Identification of Microorganisms:
   • Perform biochemical tests or molecular techniques to identify specific microbial species, if required.
   • Record and interpret identification results as per regulatory guidelines.
4. Endotoxin Testing:
   • Perform endotoxin testing using Limulus Amebocyte Lysate (LAL) assay or other validated methods.
   • Prepare samples and reagents according to manufacturer instructions.
   • Interpret test results based on established acceptance criteria.
5. Documentation and Reporting:
   • Document all test results, observations, and calculations accurately and legibly.
   • Report water testing results to the appropriate personnel and maintain records as per regulatory requirements.

Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control
• TVC: Total Viable Count
• TCC: Total Coliform Count
• LAL: Limulus Amebocyte Lysate
• CFU/ml: Colony-Forming Units per milliliter

Documents

• Water Testing Records
• Sampling Point Log
• Microbial Enumeration Results
• Endotoxin Testing Results

Reference

United States Pharmacopoeia (USP) General Chapter Microbial Enumeration Tests

SOP Version

Version 1.0