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Pharmaceutical Water System Validation Audit Checklist

A comprehensive audit checklist for evaluating pharmaceutical water system validation processes, ensuring regulatory compliance, and maintaining the highest standards of water quality for pharmaceutical manufacturing.

Pharmaceutical Water System Validation Audit Checklist
by: audit-now
4.6

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About This Checklist

Water is a critical utility in pharmaceutical manufacturing, used as an ingredient, processing aid, and cleaning agent. This Water System Validation Audit Checklist is designed to comprehensively evaluate the validation and ongoing control of pharmaceutical water systems, including Purified Water (PW) and Water for Injection (WFI) systems. By systematically assessing system design, installation, operation, maintenance, monitoring, and quality control processes, this checklist helps ensure the consistent production of water that meets pharmacopoeial and regulatory standards. Regular use of this checklist supports compliance with Good Manufacturing Practices (GMP), enhances product quality, and minimizes risks associated with water-borne contamination in pharmaceutical products.

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Industry

Healthcare

Standard

Pharmaceutical Water Systems Standards

Workspaces

Pharmaceutical Manufacturing Facilities

Occupations

Water System Specialists
Quality Assurance Managers
Validation Engineers
Microbiologists
Facility Managers

1
Is the Purified Water system compliant with USP <1231> standards?

Select compliance status.

To ensure the water system meets regulatory requirements.
2
What is the microbial count in the Purified Water system?

Enter the microbial count.

To assess the water quality control measures in place.
Min: 0
Target: 0
Max: 10
3
Is the water system sanitized according to protocols?

Select sanitization status.

To verify compliance with sanitization procedures.
4
What measures are in place for water quality control?

Provide details of quality control measures.

To document and evaluate the controls implemented.

5
Is the Water for Injection (WFI) system compliant with EP 5.1.1 standards?

Select compliance status.

To ensure the WFI system meets European Pharmacopoeia requirements.
6
What is the conductivity reading of the WFI system?

Enter the conductivity reading in µS/cm.

To assess the ionic purity of the water system.
Min: 0
Target: 1.1
Max: 1.3
7
Are effective microbial control measures in place in the water system?

Select microbial control status.

To ensure microbial control is actively managed.
8
Describe the sanitization procedures used for the water system.

Provide details of the sanitization procedures.

To ensure proper documentation of sanitization procedures.

9
Is the water system properly qualified as per GMP requirements?

Select qualification status.

To verify that the water system meets Good Manufacturing Practice standards.
10
What is the current temperature of the water system?

Enter the temperature in degrees Celsius.

To ensure that the water system is maintained within acceptable temperature limits.
Min: 15
Target: 20
Max: 25
11
Is the validation protocol for the water system followed?

Select validation protocol compliance status.

To confirm adherence to established validation procedures.
12
Describe the change control process for the water system.

Provide details of the change control process.

To ensure that any changes are properly documented and managed.

13
Is the water quality monitored at the required frequency as per regulations?

Select monitoring frequency compliance status.

To ensure compliance with monitoring requirements for water quality.
14
What is the Total Organic Carbon (TOC) level in the water system?

Enter the TOC level in ppb.

To assess the organic impurity levels in the water.
Min: 0
Target: 500
Max: 500
15
Are adequate control measures in place for chemical contamination?

Select chemical contamination control status.

To ensure that potential chemical contaminants are effectively managed.
16
Document any incidents related to water quality breaches.

Provide details of incidents and corrective actions.

To maintain a record of any quality issues and corrective actions taken.

17
Has the water system undergone integrity testing in the last year?

Select integrity testing status.

To ensure that the water system maintains its structural integrity and function.
18
What were the results of the last pressure test conducted on the water system?

Enter the pressure test result in PSI.

To verify that the system can withstand specified pressure levels.
Min: 0
Target: 5
Max: 10
19
Are leak detection measures effectively implemented in the water system?

Select leak detection measure status.

To ensure that any leaks are detected and managed promptly.
20
Provide comments related to recent maintenance activities on the water system.

Detail recent maintenance activities.

To document maintenance history and actions taken for system integrity.

FAQs

The checklist covers water source assessment, pretreatment systems, purification technologies (e.g., reverse osmosis, distillation), storage and distribution systems, sanitization procedures, and monitoring programs for chemical and microbiological quality.

Comprehensive audits should be conducted annually, with more frequent assessments of critical parameters and periodic review of trending data. Revalidation should be performed after any significant changes to the system.

The audit team should include water system specialists, quality assurance personnel, microbiologists, engineers familiar with water purification technologies, and validation experts.

The checklist includes specific sections for different water grades (e.g., Purified Water, Water for Injection), addressing the unique requirements and critical quality attributes for each type.

Yes, the checklist is designed to be applicable to both new system qualifications and ongoing validation of existing systems, with sections addressing initial validation, periodic review, and change control processes.

Benefits

Ensures compliance with global regulations for pharmaceutical-grade water systems

Enhances the reliability and consistency of water quality in pharmaceutical manufacturing

Reduces risks associated with microbial contamination and chemical impurities

Optimizes water system performance and efficiency

Supports a robust water quality management program