Purified Water D

S.No. Name of Document Full Form

1 URS User Requirement Specification

2 FDS Functional Design Specification

3 P&ID Process & Instrument Diagram

4 Valve Schedule Valve Schedule

5 Instrument Schedule Instrument Schedule
6 Equipment Schedule Equipment Schedule
7 Utilities Schedule Utilities Schedule

8 GA Drawing General Arrangement Drawing

9 DQ Design Qualification

10 SDS Software Design Specification

11 STS Software Test Specification
12 HDS Hardware Design Specification
13 HTS Hardware Test Specification
14 GAMP Categorisation Good Automated Manufacturing Practice
Categorisation
15 MFAT Mechanical Factory Acceptance Test

16 FAT Factory Acceptance Test

17 SAT Site Acceptance Test

18 IQ Installation Qualification

19 Commissioning Protocol Commissioning

20 OQ Operation Qualification

21 PQ Performance Qualification

22 VMP Validation Master Plan

23 QPP Quality & Project Plan

24 QIP Quality Inspection Plan

Purified Water Manual

PWM
 Purified Water DOCUMENTATION
Definition
To tell the supplier what the customer requires, what specification that needs to be adhered to, how
much water is needed, what the water system is to do etc.
To describe the components of the equipment, how it will be connected together and how the system
functions. This is the supplier’s response to the clients URS.
Drawing of the system, that shows all valves, instruments, and equipment. This is the principal design
document created by the supplier.
Lists all the valves and the valve specification.
Lists all the instruments and the instrument specification.
Lists all the equipment and the equipment specification.
Lists all the utilities and the utility specification, such as water, drains, electricity, steam, air, chemicals
etc. Created by the supplier.
Equipment layout drawing, showing information as to the connections to the equipment and their
locations
The design qualification or enhanced design review is carried out to ensure that the designed
equipment, using the design documents, meets the user requirements.
To describe the control panel software function and design
To test the functions described in the SDS
To describe the control panel hardware function and design
To test the functions described in the HDS
To categorise configurable instruments. This gives information on how to record configuration
and validation process that should be used
To test the equipment at the supplier’s factory without running water through the system. The
system does not have to be fully assembled for this. Checks include ensuring the correct
equipment is available
To test the equipment operationally in the factory with water. This tests all the equipment
functionality.
This document tests the equipment on site. The SAT can be a combination of the IQ,
Commissioning and OQ documents, depending on each client’s understanding.
To document that the equipment is correctly installed on site as intended. The supplier
normally creates this document.
To document that the system is correctly set up and that the system is made ready for full
functional operation. This document records all the start up data. The supplier creates this
document.
To document that the system functions and operates as described in the FDS. The supplier
normally creates this document.
To record that the system produces good quality water and that the quality is consistent when
the system is on line.
This documents the client’s approach to validation on site and in particular to the current site project.
It identifies the scope of the validation exercise allowing the validation on site to be suitably managed.

This document defines how the supplier will fulfil the user and supplier’s quality requirements on the
project. It also provides details of the project management on the contract. This may include a Gantt
chart for the project management of the contract. This is the supplier’s response to the VMP.
This document gives details of how and when the equipment that is to be supplied is inspected at the
supplier’s works. This details the type of inspection and who will inspect, also giving options as to
when it is suggested that the client inspects.

It is First most important document which describes overall quality of Purified water for
Pharmaceutical purpose as per production need. It comprises of complete data set of raw water
quality, PW quality, Complete GAD, Instrument list, Calibration record, Sampling plan & points with
Analytical Parameter, ALL SOPs List, Alert & Action Limit, critical point, FMEA, Equipment & Instrument
Detail, Documentation Control, and Validation Data along with Prototype of all Formats/Forms, special
emphasis of cleaning & sanitisation, personal training etc.
Responsibility
Document created by the client or his
engineer.
Document created by the SUPPLIER

Document created by the SUPPLIER

Document created by the SUPPLIER

Document created by the SUPPLIER
Document created by the SUPPLIER
Document created by the SUPPLIER

Document created by the SUPPLIER

The review is documented and created by

the supplier.
Document created by the SUPPLIER
Document created by the SUPPLIER
Document created by the SUPPLIER
Document created by the SUPPLIER
Document created by the SUPPLIER

Test Done by Client on Suppliers Factory

Test Done by Client on Suppliers Factory

The supplier creates the SAT document.

Document created by the SUPPLIER

Document created by the SUPPLIER

Document created by the SUPPLIER

The user creates this document.

Document created by the client or his
engineer.

Document created by the SUPPLIER

Document created by the SUPPLIER
Important Compiled Documents
User Requirement Specification
Functional Design Specification
Design Change Control
Process & Instrument Diagram
Valve Schedule
Instrument Schedule
Equipment Schedule
Utilities Schedule & Consumption
General Arrangement Drawing
Material Test Certificates
Welding Qualifications
Training Certificates
Operating and Maintenance Manuals.
Recommended Spares Parts List
Process/Sequence Flow Diagrams
Detailed Design and Production Programme
Instrument/Equipment Location Drawings
Calibration Certificates for Instruments,
Calibration Certificates for Instruments used to Test Equipment
Standard Operation Procedures for Operation & Maintenance
Design Qualification
Software Design Specification
Software Test Specification
Hardware Design Specification
Hardware Test Specification
Good Automated Manufacturing Practice Categorisation
Mechanical Factory Acceptance Test
Factory Acceptance Test
Site Acceptance Test
Installation Qualification
Commissioning Protocol
Operation Qualification
Performance Qualification
Validation Master Plan
Quality & Project Plan
Quality Inspection Plan
Warranty Certificates
AMC Contract Letter
Copies of Purchase orders
Copies of Bills of Quantities (BOQ)/ BOM
Vendor Details & Vendors Certificate True Copies
List of Dosing Consumables requirement
Sampling Point Schedule
URS
FDS/ FS

PID

GAD

O&M

DQ
SDS
STS
HDS
HTS
GAMP Categorisation
MFAT
FAT
SAT
IQ

OQ
PQ
VMP
QPP
QIP
 Audit Checklist for Purified Wa
Sr. No.

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 Audit Checklist for Purified Water Sys
Compliance to be checked

Is there a validated system for water treatment drawn from own or other sources?

Are the sources of raw water, treatment processes, sampling plans specified?

Are the distribution points and storage for raw and purified water system specified?

How is the bioburden of purified water system reduced or controlled?

Are the water tanks cleaned periodically?

Are records maintained on cleaning activities?
Is the water distribution system sanitized to control contamination due to microbes?

Are the cleaning procedures and critical support systems validated?

Is the qualification of water system done in accordance with the protocol?

Does the IQ protocol include the review of facility and specifications of equipment like its
design, welding roughness on pipelines, dead points or sections in the pipelines?

Does the protocol include SOP for operations, maintaining, cleaning and calibration of
gadgets?
Does the report for IQ protocol include Summary and description of the assay performed with
data tables, results conclusions, reference of the protocol and revision and approval signatures?

Does the OQ protocol include system production capacity (L/min), water rate, flow type, valve
operation with alarm and control operations?

Is a report maintained on OQ protocol with summary, description, data tables, conclusion,

results, and reference of the protocol, revision and approval signatures?

Are the three stages of PQ followed in phases 1, 2, 3?

Are the operation parameters, sanitation and cleaning procedures followed in Phase 1?

Are the SOPs prepared and maintained for phase 1 with sampling records for 2-4 weeks?

Are the sampling records maintained for pre-treatment point in phase 2 after phase 1?

Are the sampling records maintained for pre-treatment point in phase 3?

Are there any personal training records?
Is the design for PW system adequate for supplying enough water of pharmacopoeial quality?

Is the holding tank for PW system fitted with sterilizing grade vent filter which is integrity
tested?
Is the PW held at more than or equal to 80oc when stored on continuous circulation?

Are the dead legs for PW system within an acceptable length?

Are limits for microbes and physical and chemical characteristics established for water
systems?
Are measures taken when the limits exceed for water system?

General Audit Requests

❏ History of business and corporate affiliations.
❏ Establishment Registration Number.
❏ Organizational chart with names and titles of key management.
❏ Facility floor plans.
❏ List of products manufactured in the facility.
❏ Results of FDA inspections since last audit or, if an initial audit, for the previous two years.
Also request company’s responses.
❏ Master File, if applicable.
❏ Quality Manual.
❏ Complete SOP list

Feed Water
❏ What is the source for the plant water (city or private supply – well ground water, or surface
water)?
❏ Is source water entering the facility, whether from a municipal supply or a private well, tested for
microbiological contamination, and what are the specifications?
❏ Is coliform bacteria testing performed according to 40 CFR 141.14; 141.21?
❏ Is source water entering the facility tested for chemical contamination, or are municipality reports
provided?
❏ Does the water meet the EPA specifications for potable water?
❏ What is the frequency of testing?
❏ If the results are provided by the water supplier, are they reviewed and approved by a suitably
qualified user?
❏ What actions are taken if specifications are not met?
❏ If the water is being tested by the user, is a written SOP describing sampling and testing available?

General Water System Requirements

❏ What water purification system is used?
❏ Is the system a one-way flow (i.e., not recirculating)? These are more problematic and difficult to
maintain as they are basically a “dead leg.”
❏ What is the velocity of the circulating system (6 fps recommended)?
❏ What is the temperature range of the water in a recirculating system (normally 65 to 80 ºC), and
how is this monitored?
❏ What is the temperature of the water in the tank?
❏ Is the tank storage time less than or equal to 24 hours for room temperature batch processing?

❏ Is there a continuous temperature recorder and controller for each storage tank?
❏ How often is the tank vent filter integrity tested and checked for condensate blockage?
❏ Is the vent filter a hydrophobic 0.2 um?
❏ What type of tubing is used? (316L Stainless Steel piping is common in WFI and purified water.
Some plastics (e.g., PVDF can also be used but must be checked for compatibility.)
❏ Is there acceptable documentation/video of the stainless steel welding and unique identification of
each welded joint?
❏ Is there a copy of the welder’s certification and the welding procedure on file?
❏ Are there any dead legs or potential areas where air can become trapped orwhere water can
stagnate?
❏ Does the system contain screw-threaded fittings instead of the required sanitary fittings?
❏ Does the system contain ball valves or other fittings that can possibly retain water from the main
system and cause potential microbial problems?
❏ Does the heat exchanger, with the exception of a double concentric tube or double sheet tube,
have a greater pressure on the water system side than the coolant?
❏ Do any of the use points in the system have 0.2 um filters (FDA prefers no in-line filters)? Actual
water microbial counts may be “masked” by filters.
❏ Review water sampling results for at least six months preceding and two months following the
manufacture of lots selected during the audit. If specifications were not met, review investigation and
corrective actions. Are the results, investigations, and corrective actions acceptable?

❏ Are the sampling locations and frequency of testing suitable for the system?
❏ Who performs sampling for the chemical and microbial samples?
❏ Check that the sampling personnel are adequately trained and the training is appropriately
documented.
❏ Are chemical and microbial results being trended? Are the results acceptable?
❏ Have changes been made to the water system since the last audit? Since the system was initially
qualified? If major system changes have occurred, have the changes been evaluated for the need for
re-qualification?

❏ Are any pumps only used periodically? These can be a source of bacterial contamination from
stagnant water.
❏ Are thorough and complete records of the system cleaning, passivation, and maintenance
maintained? The records should include who performed and supervised the cleaning, date, cleaning
agents used, pH, conductivity, and microbial results.

❏ What chemical sanitization is used, and is it adequate?

❏ How often are the reverse osmosis membrane seals checked for integrity to prevent bypass and
contamination?
❏ Is there a maintenance program for the reverse osmosis to prevent membrane fouling and
integrity failure?
❏ If resins are regenerated on site, what SOP is followed?
❏ Are the ion-exchange beds tested microbiologically and chemically after regeneration?
❏ What is the quality of the regenerant chemicals? Are they released by QC before use?
❏ Is regeneration of the cation/anion/mixed-bed resins documented?
❏ If the resins are regenerated off site, does the manufacturer have written certification that the
units have been used for treatment of water in only systems such as this?
❏ Are cation/anion/mixed-bed resins regenerated, or are virgin resins always used?
❏ Has the correlation between in-line and laboratory testing for conductivity and TOC been
established?
❏ What is the minimum output of the UV light in the system before replacement is required?
(normally 40-50% of original)
❏ What wavelength of light is used? (254nm; germicidal, 185nm; TOC reduction)
❏ Is there a maintenance program for the UV lamp, especially cleaning of the lens to maintain
effectiveness?
❏ Are the established specifications and corresponding action and alert levels suitable and based on
historical/statistical data?
❏ Have any vendors supplying products for the system been qualified?
❏ Are any of the components controlled/monitored by a computer or programmed logic controller?
If so, has the system been validated?

Microbial and analytical test results

• Are these acceptable or acceptable with investigations and corrective actions?
• Are sampling plans defined which include a defined purpose and evidence for:
• Verification of quality attributes in treatment, distribution, and points of use?
• Supporting the compliance profile?
• Gathering validation samples?
• Verifying continued quality of source water supply?
• Is trending of results done, and does it indicate anything?

Installation Qualification
• Approved protocol?
• Meet acceptance criteria?

Operational Qualification
• Approved protocol?
• Meet acceptance criteria including daily sampling after each step of the purification process at each
point of use for two to four weeks?
• Are the operational SOPs approved?
• Repeat testing as above.

Performance Qualification
• Approved protocol?
• Meet acceptance criteria including: WFI sampling one point of use each day with all points tested
weekly. Complete a year of testing and meet specifications?

Change control requests

• Review decision where revalidation of the system was not performed. Were these justifiable?
• Does the level of testing relate to the type of change made?
• Was water used before the final approval of the documentation? If so, why?

Quality investigations relating to the system or any water-related problems

• Note any open investigations that have not been closed within 30 days. This must be defined in the
SOP. Why are they still open, and is senior management aware of the situation?

• Are the investigations adequate?

• Were the corrective actions suitable and effective in preventing repeat occurrences?
• Is trending done and reported to senior management and QA on a regular basis?
• Are problems of a similar/same type being reported more than once? (This could indicate a more
serious underlying problem.)

Area, equipment, and maintenance log books

• Are the SOP requirements being met?
• Are the books complete?

SOPs:
Operation and maintenance of the system
Sampling and handling
Change control
• Review content and completeness
• Do the SOPs reflect actual procedures observed or being documented?
Batch release SOP (if applicable)
• What documentation is required to release the batch?
• Who physically releases the batch and how?
• Are batches ever used before receiving the quality release documentation?
Shut Down and power failure

Calibration records
• Select equipment and examine the records. Are outside vendor records reviewed and approved by
suitably qualified personnel of the company owning the equipment?
• What actions are taken when a result is out of calibration?
Water For Injection (WFI)
❏ Is the water prepared by distillation or reverse osmosis?
❏ Is clean steam (free of additives) used to generate the WFI?
❏ How is the feed water treated prior to the distillation? Is the source water chlorinated, carbon
treated, deionized?
❏ Is endotoxin testing performed on the tank, pre/post-final treatment step and points of use?

❏ What is the level of endotoxins from the feed water, and is it appropriate to feed the still or
reverse osmosis? (Stills normally only affect a 2.5 to 3 log reduction in endotoxin content.)

❏ Is the system in a state of control and producing water of a quality suitable for its intended use?
fied Water System
Complies as per established Reference Document
Systems? Yes/No
 SOPs of Purified Water System
Name of SOP
PERIODIC SANITISATION OF PURIFIED WATER SYSTEM

Measurement of pH for Water

Estimation of Conductivity in Water Samples
Estimation of Turbidity
Estimation of Alkalinity
Estimation of Total Suspended Solids
Estimation of Dissolved Solids
Estimation of Hardness
Estimation of Calcium
Estimation of Magnesium
Estimation of Sodium
Estimation of Potassium
Estimation of Phosphate
Estimation of Phosphate (Ortho or Dissolved)
Calculation of Residual Sodium Carbonate, Sodium Absorption Ratio,
Percent Sodium
Estimation of Total Residual Chlorine
Estimation of Chloride
Estimation of Sulphate
Estimation of Fluoride
Estimation of Total Kjeldhal Nitrogen
Estimation of Ammonical Nitrogen
Calculation of Free Ammonia
Estimation of Nitrate
Estimation of Sulfide
Estimation of Cyanide
Estimation of Hexavalent Chromium
Estimation of Biological Oxygen Demand
Estimation of Chemical Oxygen Demand
Estimation of Oil and Grease
Estimation of Phenol in Water & Waste Waters
Estimation of Boron
Bioassay Test for Evaluating Acute Toxicity of Industrial Effluents and Waste Waters Using
Common Carp
Bioassay Test for Evaluating Acute Toxicity of Industrial Effluents and Waste Waters - Part 2
using Toxicity Factor to Zebra Fish
Determination of Total Coli forms and Fecal Coli Forms
Determination of Total Coliforms and Fecal Coliforms (MPN Method)
Methods for Gaseous Air Sampling
Determination of Suspended Particulate Matter in Ambient Air
Measurement of Respirable Suspended Particulate Matter (PM 10) in Ambient Air
Determination of Sulphur Dioxide in Ambient Air
Determination of Nitrogen Dioxide in Ambient Air
Estimation of Lead in Ambient Air
Determination of pH for Soil and Sludge Samples
Estimation of Conductivity in soil and sludge samples.
Determination of organic carbon.
Determination of Total Water Soluble Solids
Determination of Total Kjeldhal Nitrogen for soil and sludge samples
Estimation of Potassium for soil and sludge samples
Estimation of Total Organic Carbon
DETERMINATION OF SLUDGE VOLUME INDEX, MIXED LIQUOR SUSPENDED SOLIDS (MLSS) AND
MIXED LIQUOR VOLATILE SUSPENDED SOLIDS (MLVSS)
DETERMINATION OF FIXED AND VOLATILE SOLIDS
Determination Of Total Solids
Determination Of Total Dissolved Solids
Determination Of Total Suspended Solids
Determination Of Turbidity Of A Water Sample Using A Nephelometer (Turbidity Meter)
Determination Of Setteable Solids Gravimetric Method
Determination Of Color Of A Liquid Sample
Measurement Of Hourly, Daily Minimum & Daily Maximum Temperatures
Determination Of Acidity
Determination Dissolved Oxygen
Determination Of Nitrite
Determination Of Phosphorous (Phosphates Po4-3) Stannous Chloride Method
Determination Of Sulphates (So4-2) Gravimetric Method
Determination Of Bromide, Phenol Red Colorimetric Method
Determination Residual Chlorine
Determination Of Carbon Dioxide
Determination Of Cyanide, Colorimetric Method
Total Cyanide After Distillation
Determination Of Iodine, Leuco Crystal Violet Method
Determination Of Sulfite, Iodometric Method
Determination Of Oil And Grease
Determination Of Phenols, Chloroform Extraction Method
Determination Of Phenols, 4-Amino Antipyrine Colorimetric Method
Determination Of Ph Of Soil/Sludge/Sediment And Solid Waste
Determination Of Electrical Conductivity
Estimation Of Calcium Content In A Soil Sample
Estimation Of Magnesium Content In A Soil Sample
Determination Of Ammonia In A Soil Sample
Total Alkalinity, Soluble Carbonates And Bicarbonates In A Soil Sample
ter System
Dept. Form/Format
ENG/ Maintenance Record of Sanitization

SOPIWTD/01
SOPIWTD/02
SOPIWTD/03
SOPIWTD/04
SOPIWTD/OS
SOPIWTD/06
SOPIWTD/07
SOPIWTD/08
SOPIWTD/09
SOPIWTD/10
SOPIWTD/11
SOPIWTD/12
SOPIWTD/13

SOPIWTD/14
SOPIWTD/15
SOPIWTD/16
SOPIWTD/17
SOPIWTD/18
SOPIWTD/20
SOPIWTD/19
SOPIWTD121
SOPIWTDI22
SOPIWTD124
SOPIWTD/23
SOPIWTD/25
SOPIWTD126
SOPIWTD127
SOPIWTD128
SOPIWTD/29
SOPIWTD/30
SOP/BTD/01

SOP/BTD/02

SOP/BTD/03
SOP/BTD/04
SOP/ATDI01 Ambient Air
SOP/ATD/02 Ambient Air
SOP/ATD/03 Ambient Air
SO PlAT D/04 Ambient Air
SOP/ATD/05 Ambient Air ETP sludge
SOP/ATD/06 Ambient Air ETP sludge
SOP/HWTD/01 ETP sludge
SOP/HWTD/02 ETP sludge
SOP/HWTD/03 ETP sludge
SOP/HWTD/04 ETP sludge
SOP/HWTD/05 ETP sludge
SOP/HWTD/06 ETP sludge
SOP/HWTD/07

Soil
Soil
Soil
Soil
 IS-3025 PART 31 (1988)
IS-3025 PART 24 (1986)
Name of SOP
PERIODIC SANITISATION OF PURIFIED WATER SYSTEM
Dept. Form/Format
ENG/ Maintenance Record of Sanitization
 RO Plant Chemical Injection

Source Well
Flow Rate from Raw water tank to Filtered W
Hypochlorite:
1.Hypochlorite is powerful oxidising agent (Na
2. It helps to kill organism present in water
Micron Media 3. It helps to kill bacteria, This is nothing but pr
Filter Note: Not injected due to water quality is goo

Raw Water
Tank
Coagulant:
1.It combines all small particles together to form
Agglomeration ( Here not injected because Turb
Hypo Chlorite MB-549 2.Our Raw water quality is good, so we are not
Coagulant WT-14 3. The Turbidity is 3NTU. Upto 15 NTU turbid
Note: Not injected due to water quality is goo

MMF

Flow Rate from Filtered water tank to RO ou

Oxygen Scavenger (Bisulphite)
Filtered Water Tank Oxidising Agent ----> Reducing Agent
1.If you find free chlorine, Thumb rule is 1 ppm
Bisulphite (HSO3-).
Antiscalant SI-4517 2. Oxygen Scavenger is generally used to neutra
O2 Scavenger OR-11 water.

RO Inlet

Antiscalant:
1. Antiscalant chemical name is Phosphonate or
RO Tank Outlet 2. Ca2++ Mg2+, Ba2++ Sr2+ this all are scaling (Ag
Antiscalant phosphonate reacts with Ca2++ Mg2
Magnesium Phosphonate which is soluble in wa
4. So the water will flow from RO Filter freely
not blocked).
RO Tank Permeate 5. SMBS (Sodium Meta Bisulphite).
Water
 Softener Inlet
Flow Rate from Softener to Boiler Feed Wat
1. Softener is removing hardness from the wate
2. Whatever Ca 2+ & Mg 2+ salts are there it w
3. Caustic is to raise the pH of the Water to 10.4
Softener Outlet 4. The pH should not increase above 10.4, to av

Sodium Hydroxide
(caustic)

Boiler Feed Water tank

Oxygen Scavenger Flow Rate from BFW Tank to OTSG Outlet

OR-11 requirement of steam.
Oxygen Scavenger
OTSG Inlet 1.Oxygen Scavenger is generally used to neutra
water.
2. Maintain the pH is greater than 7.

OSTG Outlet
 Injection

aw water tank to Filtered Water tank is 240 GPM

owerful oxidising agent (NaOCl---> O Cl- )

ganism present in water
cteria, This is nothing but primary biocide
due to water quality is good. ( Turbidity 3 NTU)

mall particles together to form larger particles,the phenomena called as

ere not injected because Turbidity is Insignificant).
uality is good, so we are not injecting Hypochlorite and Coagulant.
3NTU. Upto 15 NTU turbidity water quality consider is good.
due to water quality is good. ( Turbidity 3 NTU)

iltered water tank to RO outlet is 240 GPM

r (Bisulphite)
--> Reducing Agent
hlorine, Thumb rule is 1 ppm of free chlorine requires 3 ppm of
).
ger is generally used to neutralised the dissolved oxygen present in

mical name is Phosphonate or Acrylate

+ Sr2+ this all are scaling (Agent) cations present in water. 3. Dosing
onate reacts with Ca2++ Mg2+ and become calcium phosphonate,
honate which is soluble in water.
l flow from RO Filter freely (Flow Rate will not reduced & Filters will

Meta Bisulphite).
oftener to Boiler Feed Water Tank is 200GPM
ving hardness from the water
& Mg 2+ salts are there it will be removed
e the pH of the Water to 10.4 in BFW Tank.
ot increase above 10.4, to avoid any scaling issue.

FW Tank to OTSG Outlet is vary& will depends upon the

eam.
r
er is generally used to neutralised the dissolved oxygen present in

is greater than 7.
Inspection of water system
The following list identifies items and a logical sequence for a WPU system inspection or audit:
—     The setting of monitoring alert and action levels;
—     monitoring results and evaluation of trends;
—     Inspection of the last annual system review;
—     Review of any changes made to the system since the last audit and check that the change control
has been implemented;
—     Review of deviations recorded and their investigation;
—     General inspection of system for status and condition;
—     Review of maintenance, failure and repair logs; and
—     Checking calibration and standardization of critical instruments.

  Maintenance of water systems

WPU systems should be maintained in accordance with a controlled, documented maintenance
programme that takes into account the following:
— Defined frequency for system elements;
— The calibration programme;
— SOPs for specific tasks;
— Control of approved spares;
— Issue of clear maintenance plan and instructions;
— Review and approval of systems for use upon completion of work; and
— Record and review of problems and faults during maintenance

System reviews
WPU (PW, HPW and WFI) systems should be reviewed at appropriate regular intervals. The review
team should comprise representatives from engineering, QA, operations and maintenance. The review
should consider matters such as:

— Changes made since the last review;

— System performance;
— Reliability;
— Quality trends;
— Failure events;
— Investigations;
— Out-of-specifications results from monitoring;
— Changes to the installation;
— updated installation documentation;
— Log books; and
— The status of the current SOP list.