Ointments: SOP for Water System Validation – V 2.0

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SOP for Water System Validation – V 2.0

Procedure for Water System Validation

Department Quality Assurance (QA)/Validation/Engineering/Production
SOP No. SOP/Ointment/143
Supersedes V 1.0
Page No. Page X of Y
Issue Date [Insert Issue Date]
Effective Date [Insert Effective Date]
Review Date [Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for the validation of water systems used in ointment manufacturing. Water system validation ensures that purified water, water for injection (WFI), and other process water meet the required quality standards for pharmaceutical production.

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA), Validation, Engineering, and Production departments responsible for water system qualification, validation, and routine monitoring.

3. Responsibilities

  • QA Officer: Ensures compliance with water system validation protocols.
  • Validation Team: Develops and executes water system validation protocols.
  • Engineering Team: Maintains water purification and distribution systems.
  • Production Supervisor: Ensures validated water is used in manufacturing processes.
  • QA Manager: Reviews and approves water system validation reports.

4. Accountability

The QA and Engineering Managers are accountable for ensuring that water system validation is conducted as per GMP, FDA, ICH, and WHO guidelines.

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5. Procedure

5.1 Phases of Water System Validation

Water system validation consists of three key phases:

  • Installation Qualification (IQ): Ensures that the water system is installed according to specifications.
  • Operational Qualification (OQ): Confirms that the water system operates within established parameters.
  • Performance Qualification (PQ): Verifies that the water system consistently produces water meeting quality specifications.

5.2 Installation Qualification (IQ)

  • Verify the installation of water system components, including:
    • Storage tanks
    • Filtration units
    • Reverse osmosis (RO) membranes
    • Deionization units
    • UV sterilization units
    • Water distribution piping
  • Check system piping for leaks and contamination risks.
  • Ensure calibration of pressure and flow sensors.
  • Document installation records and approve IQ reports.

5.3 Operational Qualification (OQ)

  • Test the water system under normal operating conditions.
  • Monitor key parameters such as:
    • Conductivity
    • Total Organic Carbon (TOC)
    • Microbial contamination levels
    • Endotoxin levels (for WFI systems)
    • pH and total dissolved solids (TDS)
  • Check system performance at multiple sampling points.
  • Ensure alarms and control mechanisms function correctly.
  • Record OQ data and approve reports before proceeding to PQ.
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5.4 Performance Qualification (PQ)

  • Assess water system stability over an extended period.
  • Monitor water quality parameters daily for at least 30 days.
  • Ensure compliance with:
    • USP & EP specifications for purified water and WFI
    • Microbial count limits
    • Endotoxin levels within acceptable limits
  • Document and approve PQ results before final validation approval.

5.5 Routine Monitoring and Revalidation

  • Schedule routine water quality monitoring and system maintenance.
  • Conduct periodic revalidation after major maintenance or modifications.
  • Ensure continuous logging of conductivity, TOC, and microbial count.

5.6 Handling Deviations

  • If water quality fails validation criteria:
    • Identify root cause and document findings.
    • Implement corrective and preventive actions (CAPA).
    • Requalify the water system after adjustments.
  • Maintain deviation records for regulatory audits.

5.7 Documentation and Review

  • Maintain all validation records in the Water System Validation Log.
  • QA must review and approve all validation reports.
  • Ensure records are available for regulatory inspections.

6. Abbreviations

  • GMP – Good Manufacturing Practices
  • QA – Quality Assurance
  • IQ – Installation Qualification
  • OQ – Operational Qualification
  • PQ – Performance Qualification
  • CAPA – Corrective and Preventive Actions
  • WFI – Water for Injection
  • USP – United States Pharmacopeia
  • EP – European Pharmacopeia
  • TOC – Total Organic Carbon
  • TDS – Total Dissolved Solids
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7. Documents

  • Water System Validation Protocol (Annexure-1)
  • Water System Validation Log (Annexure-2)

8. References

  • USP & EP Guidelines for Water System Validation
  • ICH Q7 – Good Manufacturing Practice Guide
  • WHO Guidelines for Pharmaceutical Water Systems
  • US FDA Guidance on Water Systems in Pharmaceutical Facilities

9. SOP Version

Version 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Water System Validation Protocol

Water System Component Validation Phase Test Parameter Acceptance Criteria
Storage Tank PQ Microbial Limit ≤ 10 CFU/mL
RO Membrane OQ Conductivity ≤ 1.3 µS/cm

Annexure-2: Water System Validation Log

Date System ID Validation Phase Test Performed Result Reviewed By
01/02/2025 WATER-1001 IQ Installation Verification Pass QA Manager
02/02/2025 RO-2002 PQ Conductivity Testing Pass QA Manager
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