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 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 including Monitoring the quality of water at every stage of purification and distribution according to the plan described below
- 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).
- Phase II: Alternate days sampling from all the sampling points and analysis including a microbial limit test for two to four weeks.
- Phase III: Carry out Sampling and analysis so that all sampling points will be covered once a week.
- 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
- 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.