FACILITY QUALIFICATION PROTOCOL

Water for Injection System Validation

ORIGINAL __X____ AMENDMENT _______

Qualification Number: _MVP-2002-002____

Special ___Normal_X__

FACILITY: Manufacture, Package, Test and Distribution

LOCATION:

Mahwah, New Jersey, Building 1

SYSTEM: Water for Injection (WFI)

CRITICAL: YES

Qualification Protocol Approvals:

Department
Name

Signature

Date

Originator

1. Purpose: To demonstrate through documented evidence that the Water for Injection system is
validated for use.
2. Roles and Responsibilities:
Activity

Responsible Department

Protocol Execution
Report Preparation
Report Approval
3. Diagram of System indicating sampling points:
4. Materials of Construction/Composition: (list here the composition of the various pieces of equipment. I
usually us a table format)

Equipment/Process element
Water tank (5,000 US gallon)
Transportation Piping
Tank piping
Coupling joint - tank

Composition
316 electropolished stainless steel
with smooth welded surfaces
PVFC 1 with support brackets
every foot
316 electropolished stainless steel
with smooth welded surfaces
316 electropolished stainless steel
Page 1 of 6

Drawing/print reference
Drawing a-1 dated 11/14/06
Drawing b-1`9 dated
11/18/06
Drawing a-1 dated 11/14/06
Drawing a-1 dated 11/14/06

FACILITY QUALIFICATION PROTOCOL

Water for Injection System Validation
ORIGINAL __X____ AMENDMENT _______
Equipment/Process element
Coupling joint Transportation
lines

Composition
PVFC 1 with support brackets
every foot

Drawing/print reference
Drawing b-1`9 dated
11/18/06

5. Procedures/Reference Documents (including drawings)

Document
Type
SOP
Working
Instruction
Working
Instruction
Working
Instruction
SOP
SOP
SOP
SOP
SOP
SOP

Procedure /Document Title

Facility Qualification
Installation Qualification

Document
Number
SOP 09-14
WI 09-03

Revision
Level
Original
Original

Operational Qualification

WI 09-04

Original

Process Qualification

WI 09-05

Original

Water for Injection Testing

Cleaning Validation
Incoming Municipal Water Testing
PM of Resin Beds
PM of Water Tank
PM of Water Transportation Lines

SOP 10-01
SOP 09-16
SOP 10 04

Original
Original
Original

6. Training Requirements:
Training Requirements

Individuals Trained

(List Doc # /Rev Level)

See attached list with final

report

See attached list with final report

Training Performed
By/Date
See attached list with final report

7. Calibration and Preventative Maintenance (attach supportive evidence):

Equipment/Item
Name
Water Tank
Ion exchangers
Resin beds
UV light source
Etc

Asset #
(refer to drawing)

70
21, 22
41, 42

Calibration
verified
N/A

Yes

N/A
N/A
N/A

Yes
Yes
Yes

8. Risk Analysis Determination

Page 2 of 6

PM verified

Signature & Date

FACILITY QUALIFICATION PROTOCOL

Water for Injection System Validation
ORIGINAL __X____ AMENDMENT _______
Attach risk documentation and customer requirements You should mock one up for whatever system
you are challenging.
9. Test Plan and Rationale:
Samples to be tested:
Samples will be chosen based on the locations identified on the drawing. Locations are based on slope,
distance from water source, frequency and type of use.
Attached is a comprehensive listing of all water uses and their source.
Test plan:
1. A cleaning validation will be performed in conjunction with the system validation to ensure
that the system validation results reflect normal use.
2. All the testing that will be used and then routinely performed is found in SOP 10-01, USP
Testing of Water for Injection
3. Samples will be drawn from each location at the frequency listed below. Volumes of
samples will be as specified within SOP and will be taken aseptically as required within the
SOP 10-01. Samples will be refrigerated upon receipt and testing within 24 hours of
receipt.
4. The sampling will reflect initial installation, and potential seasonal changes to the public
water supply input. This facility qualification with the specific water system validation will
be ongoing for a period of 1 year to reflect seasonal influences.
5. The equipment settings for each series of tests will be recorded on the attached data sheets
when samples are taken.
6. Cleaning will be performed initially prior to any routine water sample for this protocol.

Sample Frequency:
Site

Frequency
Daily for one year (when plant is in operation)
Daily for 2 weeks
Once/week for 2 weeks
Once/month for remainder of year
Daily for 2 weeks
Once/week for 2 weeks
Once/month for remainder of year
Daily for 2 weeks
Once/week for 2 weeks
Once/month for remainder of year
Daily for 2 weeks
Once/week for 2 weeks
Once/month for remainder of year
Daily for 2 weeks (in order of nearest to farthest

Incoming to plant
Prior to resin beds

After resin beds

Before holding tank

After holding tank

Identified points of use

Page 3 of 6

FACILITY QUALIFICATION PROTOCOL

Water for Injection System Validation
ORIGINAL __X____ AMENDMENT _______
Site

Frequency
point from tank and always prior to use)
Daily for points of active use and once every 2
weeks for non-active use

Sample Frequency Rationale:

Sample Identification and Labeling Instructions:

10. Criteria and Results:

Raw data sheets should be attached.

Attribute

Inspection/Test
Method

Acceptance
Criteria

Sample
Size

pH
Appearance
Particulates
Microbial load

11. Comments, Deviations and Revisions

12. Sample Disposition:

13. Control Post Validation (to monitor state of control challenged in the original activity):

14. Final Report summary (attach all data sheets, etc):

Attribute
Inspection/Test
Acceptance
Method
Criteria

Sample
Size

Result
(Pass/Fail/Justify*)
*If Justify, provide
rationale

pH
Appearance
Particulates
Microbial load

Page 4 of 6

FACILITY QUALIFICATION PROTOCOL

Water for Injection System Validation
ORIGINAL __X____ AMENDMENT _______
15. Conclusion: (Indicate if the system is considered validated or not and if not, what other activities/steps will be taken)
16. Report Approval and Concurrence:
Department
Originator

Name

Signature

Operations
Quality Assurance

Page 5 of 6

Date

FACILITY QUALIFICATION PROTOCOL

Water for Injection System Validation
ORIGINAL __X____ AMENDMENT _______
SUPPLEMENTAL DATA SHEETS

Page 6 of 6