Standard Operating Procedure for Water System Monitoring

1) Purpose

This SOP outlines the procedures for monitoring the pharmaceutical water system to ensure quality and compliance with regulatory standards.

2) Scope

This SOP applies to the monitoring of pharmaceutical water systems including purified water (PW), water for injection (WFI), and other water systems critical to pharmaceutical manufacturing.

3) Responsibilities

The Quality Control (QC) department is responsible for monitoring the pharmaceutical water system. The Facilities or Engineering department ensures the operational integrity of the system. Quality Assurance (QA) oversees the process to ensure compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Sampling Plan

1. Develop a sampling plan that specifies the frequency and locations for water sampling (e.g., inlet, outlet, points of use).
2. Ensure that sampling points are representative of the entire water distribution system.

4.2 Physicochemical Testing

1. Perform physicochemical tests on water samples according to compendial or in-house specifications (e.g., conductivity, total organic carbon, microbial limits).
2. Use validated analytical methods and calibrated instruments for testing.

4.3 Microbiological Testing

1. Perform microbiological testing on water samples to ensure absence of objectionable microorganisms (e.g., total viable count, endotoxin testing).
2. Follow compendial methods or validated in-house methods for microbiological testing.

4.4 Trend Analysis

1. Analyze monitoring data over time to identify trends and deviations from established norms.
2. Investigate any deviations and implement corrective actions as necessary.

4.5 Documentation

1. Document all water system monitoring activities, including sampling, testing, results, and corrective actions, in designated logbooks or electronic systems.
2. Prepare monitoring reports summarizing findings and trends for review by QA and regulatory agencies.
3. Review and approve monitoring reports to ensure compliance with regulatory requirements and internal procedures.

5) Abbreviations, if any

SOP: Standard Operating Procedure
PW: Purified Water
WFI: Water for Injection
QC: Quality Control
QA: Quality Assurance

6) Documents, if any

Water System Monitoring Protocol, Monitoring Records, Testing Reports, Trend Analysis Reports

7) Reference, if any

Regulatory guidelines such as USP <1231> Water for Pharmaceutical Purposes, FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice

8) SOP Version

Version 1.0