PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PERFORMANCE QUALIFICATION FOR PROCESS WATER GENERATION &
DISTRIBUTION SYSTEM
PERFORMANCE QUALIFICATION
PROTOCOL
FOR
PROCESS WATER GENERATION &
DISTRIBUTION SYSTEM
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PERFORMANCE QUALIFICATION FOR PROCESS WATER GENERATION &
DISTRIBUTION SYSTEM
Signing of this Performance Qualification Protocol indicates agreement with the Validation Master Plan
approach of the equipment. Further if any changes in this protocol are required, protocol will be revised
and duly approved.
PREPARED BY:
Organization Name Designation Signature Date
CHECKED BY:
Organization
Name Designation Signature Date
APPROVED BY:
Organization
Name Designation Signature Date
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PERFORMANCE QUALIFICATION FOR PROCESS WATER GENERATION &
DISTRIBUTION SYSTEM
TABLE OF CONTENTS
1 OBJECTIVE ................................................................................................................................................. 4
2 SCOPE .......................................................................................................................................................... 4
3 RESPONSIBILITIES .................................................................................................................................. 4
4 SYSTEM DESCRIPTION ........................................................................................................................... 5
5 DOCUMENTATION REQUIREMENTS ................................................................................................. 5
6 DATA COLLECTION ................................................................................................................................ 6
7 CHANGE CONTROL ................................................................................................................................. 6
8 PRE-QUALIFICATION REQUIREMENTS ............................................................................................ 7
8.1 System Pre-requisites ............................................................................................................... 7
9 TESTS AND CHECKS ................................................................................................................................ 8
9.1 Water system monitoring, sampling and testing ...................................................................... 8
9.1.1 Purpose ............................................................................................................................ 8
9.1.2 Method.............................................................................................................................. 8
9.1.3 Acceptance Criteria ....................................................................................................... 12
9.1.4 Results of Daily sampling and testing for System .......................................................... 13
10 CHECKLIST OF ALL TESTS AND CHECKS ..................................................................................... 14
11 VARIANCE SHEET .................................................................................................................................. 14
12 REFERENCES ........................................................................................................................................... 15
13 LIST OF APPENDICES ............................................................................................................................ 16
14 SUMMARY ................................................................................................................................................ 17
15 APPROVALS ............................................................................................................................................. 18
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PERFORMANCE QUALIFICATION FOR PROCESS WATER GENERATION &
DISTRIBUTION SYSTEM
1 OBJECTIVE
The objectives of this Performance Qualification (PQ) are as follows:
To verify that the equipment performs in accordance with the design and user requirements as
defined by set acceptance criteria and complies with relevant cGMP requirements.
To demonstrate that the system will perform reproducibly and consistently within its operating
range
Following execution of the protocol a summary report will be written and approved. All results,
conclusions, exceptions and variances will be addressed and final disposition of the equipment will be
stated. Successful completion of this protocol and approval of the summary report will verify that the
Process Water Generation & Distribution System meets all the acceptance criteria and is ready for GMP
use.
2 SCOPE
This protocol covers all aspects of Performance Qualification for the Process Water Generation &
Distribution System serving the ...........Tablets, Capsules and Liquid Orals Manufacturing Facility. Scope
incorporates qualification of all components starting from Chlorination System, Raw Water Storage &
Pumping System, Dual Media Filter, Potable Water Storage & Pumping System, De-chlorination System,
and Serial Softeners with Brine Measuring Tank & Salt Saturation Tank, Soft Water Storage & Pumping
System and Process Water Storage & Pumping System.
This protocol will define the methods and documentation used to qualify the Process Water Generation &
Distribution System for PQ.
3 RESPONSIBILITIES
All work is to be performed under ..................over site and according to approved procedures.
Engineering Validation Personnel
The following are the responsibilities of Engineering Validation Personnel:
Preparation, Review and submission of PQ Protocol.
Ensures that the protocol is in compliance with current policies and procedures.
Ensures that the content is sufficient, clearly defined technically sound and accurate.
Ensures compliance with design specifications.
Validation Personnel
The following are the primary responsibilities of the Validation Personnel:
Overall cGMP compliance for PQ
Review and Pre-Approval of PQ Protocol
Execution of this PQ protocol
Document Control of PQ Protocol until such document is completed, approved and after.
Regulatory Compliance Review of the completed PQ Protocol
Review and Approval of the executed PQ Protocol
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PERFORMANCE QUALIFICATION FOR PROCESS WATER GENERATION &
DISTRIBUTION SYSTEM
4 SYSTEM DESCRIPTION
The purpose of Process Water Generation & Distribution System is to generate potable water & process
water for Potable water distribution system for Formulation & Process Area B, Process water distribution
system and feed for Purified water generation system. The Process Water Generation & Distribution
comprises of Chlorination System, Raw Water Storage & Pumping System, Dual Media Filter, Potable
Water Storage & Pumping System, De-chlorination System, and Serial Softners with Brine Measuring
Tank & Salt Saturation Tank, Soft Water Storage & Pumping System and Process Water Storage &
Pumping System.
Process Water Generation & Distribution System has been ordered to the following vendors:
Ion Exchange (India) Ltd.
Enmax Systemz “ Grundfoss”
AIPA Automation Pvt. Ltd.
Raw Water from Deep bore-well (2 nos.) is taken as a feed for this system. On line chlorination is done
through NaOCl dosing. Chlorinated water is stored in Raw Water storage tanks. Chlorination is carried out
for water before being stored in Tank to protect water from bacterial growth. Raw Water from water
storage tanks are pumped by Raw Water transfer pump (1W+1S) to 1 No. Multi-grade filter. Filtered water
coming from Multi-grade filter is stored in 3 Nos. potable water storage tank. Potable Water from Potable
Water storage tank is pumped by potable water pumps (1W+1S) to 2 Nos. of softners. Online Na2S2O5
(Sodium Meta Bi-Sulphite) dosing is done on Potable Water coming from water transfer pump to remove
dissolved chlorine in water. De-chlorination is carried out for water entering to softeners for protection of
resin against residual chlorine. Tapping for supply to Potable Water Distribution System (Hydro
Pneumatic System) for Formulation Plant is done before De-chlorination.
Water coming from softner is stored in 2 Nos. soft water tank Soft Water from one tank is pumped by soft
water transfer pump (1W+1S) to feed as make up water for Cooling Tower HVAC, make up water for
Cooling Tower DG sets, make up water for Hot Water HVAC, make up water for Chilled Water HVAC &
make up water Boiler.
Soft Water from second soft water storage tank is pumped through process water transfer pumps (1W+1S)
to feed for Purified Water Generation and to Process Water Distribution. Online chlorination is done after
transfer pump (P804 A/B).
Process Water Generation and Distribution System is being supervised and controlled by Panel mounted
microprocessor stand alone indicator & controllers alarm with annunciation.
5 DOCUMENTATION REQUIREMENTS
The PQ File should include:
This PQ Protocol.
All laboratory test results or their referenced location.
All executed routine check sheets.
Any change control actions that may have occurred during the qualification activities.
Any variances, exceptions or investigation reports generated during the qualification activities.
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PERFORMANCE QUALIFICATION FOR PROCESS WATER GENERATION &
DISTRIBUTION SYSTEM
6 DATA COLLECTION
All personnel shall have suitable documented training or experience.
All approvals shall be made in BLUE ink.
All data entry shall be made in BLUE ink.
All corrections to this Protocol, which are not retyped, are to be made in BLUE ink. All written corrections
to this Protocol or to data entered in this Protocol should be made by using a single line to delete the error.
The person who makes the correction shall initial and date it and add comment to explain reason for
correction.
After performing the qualification tests, collect all relevant printouts, check sheets, Laboratory test results
and certificates and retain for inclusion in the PQ File. If more Data Sheets or Variance Sheets are
required, they are to be attached to this Protocol as Appendices and to be listed in Section 13. List of
Appendices.
7 CHANGE CONTROL
Any changes or modifications to the system shall be performed in accordance with the Project Change
Control Procedure.
Change Control Forms raised during the execution of this PQ will be filed along with the protocol. An
assessment will be made for each change to determine whether or not any re-validation is required.
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PERFORMANCE QUALIFICATION FOR PROCESS WATER GENERATION &
DISTRIBUTION SYSTEM
8 PRE-QUALIFICATION REQUIREMENTS
The results of any tests should meet the limits and acceptance criteria specified in the test documents. Any
deviations or issues should be rectified and documented prior to PQ commencing. Open action items
resulting from these tests shall be listed in the Comments section.
8.1 System Pre-requisites
Completed
S.No. Description of Pre-requisite Verified By Date
[Yes / No]
Verify that the OQ of the Process Water
1 Generation and Distribution System has been Yes/No*
executed and approved.
Note:- * -Circle one, which is appropriate.
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PERFORMANCE QUALIFICATION FOR PROCESS WATER GENERATION &
DISTRIBUTION SYSTEM
9 TESTS AND CHECKS
9.1 Water system monitoring, sampling and testing
9.1.1 Purpose
The objective of the test is to ensure that the Process Water Generation & distribution system can
consistently, over a 28 day period (14 days phase I and 14 days phase II), meet the following at all sample
points
Microbiological standard
Specifications from the IS – 10500-1991.
9.1.2 Method
The strategy for water system monitoring, sampling and testing as defined below is used to:
1. Establish documented evidence for consistent operation of the treatment stages.
2. Establish a reference for the action and alert limits based on the plant microbial performance at
intermediate process stages.
3. Confirm that the overall plant operates to specification over a prolonged period of time when
operated and maintained to the SOP’s
Monitoring, sampling and testing will take place over a 28day (14 days phase I and 14 days phase II),
Sampling for testing will be as per sampling plan described below as sampling Plan (Table-2) covering all
the sampling points listed in Test location (Table-1)
Test locations -Table-1
Description Sample Points
Outlet of Bore well Pump I RW01
Outlet of Bore well Pump II RW02
Post Online Chlorination System RW03
Before MGF RW04
After MGF RW05
Before Softner RW06
After Softener SW01
Post Tank T- 802 B SW02
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PERFORMANCE QUALIFICATION FOR PROCESS WATER GENERATION &
DISTRIBUTION SYSTEM
Sample Sample
Description Description
Points Points
SW07 Process Water Tank SW25 Coating III
SW08 Liquid Filling (Syrup Preparation) (a) SW26 Solution Preparation – Coating III & IV
SW09 Liquid Filling (b) SW27 Dry Compaction (a)
SW10 Liquid Filling (Bottle Cleaning) (c) SW28 Dry Compaction (b)
SW11 Media Destruction SW29 Solution Preparation – Coating I & II
SW12 Chemical Testing SW30 Coating I
SW13 Hot Area SW31 Coating II
SW14 Chemical Wet Lab (a) SW32 Hose Keeping (PM)
SW15 Chemical Wet Lab (b) SW33 Sifting & Milling III
SW16 TOC / GC Room SW34 Granulation II (a)
SW17 Glassware Washroom SW35 Granulation III
SW18 Chemical Shower SW36 Granulation II (b)
SW19 House Keeping (RM Store) SW37 Granulation II (c)
SW20 Wash Room (Sifting) SW38 Sifting and Milling I
SW21 Wash Room (Coating) SW39 Sifting and Milling II
SW22 Bin Washing (Ist Floor) SW40 Granulation I (a)
SW23 Small Volume SW41 Granulation I (b)
SW24 Coating IV SW42 Wash Room (RM)
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PERFORMANCE QUALIFICATION FOR PROCESS WATER GENERATION &
DISTRIBUTION SYSTEM
Sampling plan – Table-2
SW07
Test RW01/
RW03 RW04 RW05 RW06 SW01 SW02 –
day RW02
SW42
1 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
2 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
3 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
4 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
5 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
6 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
7 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
8 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
9 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
10 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
11 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
12 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
13 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H Refer
Table 3
14 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H on
15 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H Page
11 of
16 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H 18
17 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
18 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
19 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
20 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
21 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
22 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
23 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
24 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
25 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
26 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
27 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
28 M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H, TDS, pH, P M, H M, H
M = Microbial Test H = Hardness
P = Potability Test TDS = Total Dissolved Solids
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PERFORMANCE QUALIFICATION FOR PROCESS WATER GENERATION &
DISTRIBUTION SYSTEM
Sampling plan – Table-3
Phase Test day Sample Points Tests
1 --- --- ---
2 SW07 SW08 SW09
3 SW10 SW11 SW12
4 SW13 SW14 SW15
5 SW16 SW17 SW18
6 SW19 SW20 SW21
Phase 7 SW22 SW23 SW24
I 8 SW25 SW26 SW27
9 SW28 SW29 SW30
10 SW31 SW32 SW33
11 SW34 SW35 SW36
12 SW37 SW38 SW39 Description,
13 SW40 SW41 SW42 Total Viable
14 --- --- --- Count,
15 --- --- --- Pathogens
16 SW07 SW08 SW09 and Total
17 SW10 SW11 SW12 Hardness
18 SW13 SW14 SW15
19 SW16 SW17 SW18
20 SW19 SW20 SW21
Phase 21 SW22 SW23 SW24
II 22 SW25 SW26 SW27
23 SW28 SW29 SW30
24 SW31 SW32 SW33
25 SW34 SW35 SW36
26 SW37 SW38 SW39
27 SW40 SW41 SW42
28 --- --- ---
st
I Month RW01 RW02 RW03 RW04 RW05 RW06
IInd Month RW01 RW02 RW03 RW04 SW01 SW02
IIIrd Month RW01 RW02 RW05 RW06 SW07 SW08
IVth Month RW01 RW02 SW09 SW10 SW11 SW12
Vth Month RW01 RW02 SW13 SW14 SW15 SW16 Analysis as
Phase VIth Month RW01 RW02 SW17 SW18 SW19 SW20 per Table
III VIIth Month RW01 RW02 SW21 SW22 SW23 SW24 No. 2 –
VIIIth Month RW01 RW02 SW25 SW26 SW27 SW28 Page No. 10
IXth Month RW01 RW02 SW29 SW30 SW31 SW32
Xth Month RW01 RW02 SW33 SW34 SW35 SW36
XIth Month RW01 RW02 SW37 SW38 SW39 SW40
XIIth Month RW01 RW02 SW41 SW42 --- ---
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PERFORMANCE QUALIFICATION FOR PROCESS WATER GENERATION &
DISTRIBUTION SYSTEM
Attach the laboratory worksheets in the appendix and transcribe the results in results section 9.1.5 and
9.1.5 as applicable.
9.1.3 Acceptance Criteria
Sampling and testing to follow sampling plan in Table –2.
Description (For all Points) Clear, colorless, odorless and tasteless liquid.
Potability Test (RW01 – RW06) Coliform should be absent
Microbial limit – Table 4
Sample Points Alert Level (CFU/ml) Action Level (CFU/ml)
RW01 NMT 300 NMT 500
RW02 NMT 300 NMT 500
RW03 NMT 300 NMT 500
RW04 NMT 300 NMT 500
RW05 NMT 300 NMT 500
RW06 NMT 300 NMT 500
SW01 NMT 200 NMT 300
SW02 NMT 200 NMT 300
SW07-SW42 NMT 200 NMT 300
Pathogen Test (For all Points) Pathogens: E. coli, Salmonella, S. aureus, P. aeroginosa should
be absent
Chemical limit – Table 5
Hardness TDS
Sample Points pH
(ppm) (ppm)
RW01 6.5 – 8.5
RW02 6.5 – 8.5
Desirable Permissible Desirable Permissible
RW03 6.5 – 8.5
Level: Max. Level: Max. Level: Max. Level: Max.
RW04 6.5 – 8.5
300 600 500 2000
RW05 6.5 – 8.5
RW06 6.5 – 8.5
SW01 NMT 10 NA NA
SW02 NMT 10 NA NA
SW07-SW42 NMT 10 NA NA
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PERFORMANCE QUALIFICATION FOR PROCESS WATER GENERATION &
DISTRIBUTION SYSTEM
9.1.4 Results of Daily sampling and testing for System
Comments:
Reviewed by Date
9.1.5 Results of Daily sampling and testing of User’s Point
Comments:
Reviewed by Date
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PERFORMANCE QUALIFICATION FOR PROCESS WATER GENERATION &
DISTRIBUTION SYSTEM
10 CHECKLIST OF ALL TESTS AND CHECKS
This checklist is provided to ensure that all tests or checks required for this protocol have been executed.
Reference
Tests or Checks Executed [Y/N] Comment
No.
9.1.4 Sampling and testing of system
9.1.5 Sampling and Testing of User’s Point
11 VARIANCE SHEET
Report any deviations from the acceptance criteria or exceptions from protocol instructions in the Record
Sheet as described in SOP–“Handling of Deviations”. Record the total number of exceptions / deviations
reported during the qualification activities of this Protocol. Record the Deviation Number and Title in the
Table below. Include all Deviation Record Sheets in the IQ File.
TOTAL NO. OF VARIANCES = __________
Variance No. Variance Title Status
Comments:
Reviewed by Date
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PERFORMANCE QUALIFICATION FOR PROCESS WATER GENERATION &
DISTRIBUTION SYSTEM
12 REFERENCES
The Principle Reference is the following
Master Validation Plan.
Schedule – M – “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment
for Pharmaceutical Products.”
WHO Essential Drugs and Medicines Policy, QA of Pharmaceuticals, Vol 2 – Good Manufacturing
Practices and Inspection.
The following references are used to give addition guidance
FDA/ISPE Baseline Pharmaceutical Engineering Guide-Volume 5:- Commissioning and Qualification
Guide, First Edition / March 2001.
Code of Federal Regulations (CFR), Title 21, Part 210, Current Good Manufacturing Practice (cGMP)
in Manufacturing, Processing, Packing, or Holding of Drugs, General. April 1, 1998.
Code of Federal Regulations (CFR), Title 21, Part 211, Current Good Manufacturing Practice (cGMP)
for Finished Pharmaceuticals, April 1, 1998.
EU Guide to Good Manufacturing Practice, Part 4, 1997.
European Commission’s working party on control of medicines and inspections document, Validation
Master Plan, Design Qualification, Installation & Operational Qualification, Non Sterile Process
Validation, Cleaning Validation, October 1999.
GAMP Guide, Validation of Automated Systems in Pharmaceutical Manufacture, Version 4.0,
December 2001.
Handling of Deviations.
Change Control Procedure.
USP-28
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PERFORMANCE QUALIFICATION FOR PROCESS WATER GENERATION &
DISTRIBUTION SYSTEM
13 LIST OF APPENDICES
Appendix No. Document Title
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PERFORMANCE QUALIFICATION FOR PROCESS WATER GENERATION &
DISTRIBUTION SYSTEM
14 SUMMARY
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PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PERFORMANCE QUALIFICATION FOR PROCESS WATER GENERATION &
DISTRIBUTION SYSTEM
15 APPROVALS
The following approvals signify that the PQ is complete and acceptable.
EXECUTED BY:
Organization
Name Designation Signature Date
REVIEWED BY:
Organization
Name Designation Signature Date
APPROVED BY:
Organization
Name Designation Signature Date
