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SOP for Water System Validation

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Purpose: SOP for Water System Validation to describe the steps to be followed for qualifying the water purification and distribution system
Scope: Standard operating procedure for Water System Validation Applicable to all water purification and distribution systems installed in the facility.
Responsibility: User Department
Accountability: Head of Validation Team.

water system validation sop

Water Validation: Monitor the performance qualification of the water system at every stage of Production and distribution as per the schedule layout.
a. It establishes documented evidence that provides a high degree of assurance that the system will consistently produce a product that meets the predetermined specifications and quality attributes.
b. Perform Re-validation of the system when any of the following events may affect the initial validation.
c. Change any piece of equipment.
d. Equipment relocation
e. Change in process of purification

Validation plan:

  1. Validation plan including Monitoring the quality of water at every stage of purification and distribution according to the plan described below
  2. Phase I: Daily Sampling from all the sampling points and analysis including microbial limits test for two to four weeks (If data is out of acceptance criteria start afresh again).
  3. Phase II: Alternate days sampling from all the sampling points and analysis including a microbial limit test for two to four weeks.
  4. Phase III: Carry out Sampling and analysis so that all sampling points will be covered once a week.
  5. Note: Production may be commenced after the completion of two to four weeks of sampling and analysis in Phase III when data are within acceptable criteria
  6. Phase III Validation is to be conducted throughout one year and prepare the trend analysis chart then fix the sampling points and frequency for routine water validation monitoring

IP: Indian pharmacopoeia
BP: British pharmacopoeia
USP: United states of pharmacopoeia
QAP: Quality Assurance Procedure
SOP: Standard Operating Procedure
DQ: Design Qualification
IQ: Installation Qualification
OQ: Operational Qualification
PQ: Performance Qualification

REFERENCES: International standard IP/BP/USP.

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