IQ PW V03 Gedeon Richter - IQ - PW

GEDEON RICHTER RUS
Quality Assurance System

Installation Qualification (IQ)
Purified Water (PW)
Generation, Storage and Distribution system
Project No.: 120501 Date: 05.12.2013 Version: V03
120501-IQ-PW
Purified Water (PW)
GEDEON RICHTER RUS

Lesnaya street 40, Yegorievsky district, Settlement Shuvoe,
Moscow Region, 140342
Protocol Function / Company Name Signature Date

Prepared by Alexey Hudzinsky
Checked by Quality & validation engineer Alina Lebedeva

OOO “BWT”
Reviewed by
Approved by
Approved by
Report Function / Company Name Signature Date

Prepared by
Checked by
Reviewed by
Approved by
Approved by
Prepared by: ah
Checked by: al 120501-IQ-PW-V03_GEDEON-RICHTER_RUS_IQ_PW_05122013 Page 1 of 44
GEDEON RICHTER RUS
Purified Water (PW)
Contents
1 Document Control 3
1.1 Revision History 3
1.2 Guidelines 3
1.3 List of used documentation 3
2 Purpose / Scope 4
3 Equipment / System Description 5
4 Installation Qualification (IQ) Execution 6
4.1 Requirements 6
4.2 Installation Qualification (IQ) Procedure 6
4.3 Working with documents 6
4.4 Completion of qualification / Approval of the documentation 6
5 Installation Qualification (IQ) Participants 7
6 List of Measuring Instruments Used in IQ 8
7 Installation Qualification Control Sheets 9
7.1 IQ-1. Documentation 9
7.2 IQ-2. System Technical Characteristics 13
7.3 IQ-3. Instrumentation 18
7.4 IQ-4. Utilities 31
7.5 IQ-5. System Compliance to GMP Requirements 33
7.6 IQ-6. Control System 39
7.7 IQ-7. Calibration 41
8 Annexes 44
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)
1 Document Control
1.1 Revision History
Version Date Description of Change

V01 05.12.2013 New Document
V02 05.12.2013 Correction after checking
V03 31.03.2014 Correction after comments of GEDEON RICHTER
1.2 Guidelines
1. EC GMP Guide, Volume 4 - Guidelines for good manufacturing practices for medicinal products for human
and veterinary use, incl. all Annexes (February 2010).
2. GOST R 52249-2009 Good Manufacturing Practice for Medicinal Products, incl. all Annexes.
1.3 List of used documentation
No. Name of the document Version Date

[1] PW Mechanical Functional Specifications (MFS) (331201-M17-0017) 3 03.12.12
[2] PW Control System URS (331201-E74-0015) 1 27.09.12
[3] PW Functional Specification (120501-FS-PW) V03d 15.11.13
[4] PW P&ID (120501-P&ID-PW) V08e 14.11.13
[5] PW Component list (120501-GS-PW) V04d 05.03.14
[6] PW Circuit diagram (120501-CD-PW) V12 -
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)
2 Purpose / Scope
The aim of production facilities and processes qualification and validation in pharmaceutical plants is to establish and
provide documented evidence that:
 the facilities, equipment and processes have been designed in accordance with the requirements of cGMP.
 the facilities and equipment have been built and installed in compliance with their specifications.
 the facilities and equipment operate in accordance with their specifications to repeatedly and reliably
manufacture products of the predetermined quality.
During Installation Qualification (IQ) an inventory is made for the equipment delivered and installed at the customer’s
site, in particular the following points are checked:
 check, if types/serial numbers (e.g. information on factory plate) and labeling of equipment comply to the
specification,
 check, if all parts of the equipment are delivered from the supplier without damage, their type complies to
specification and all parts of the equipment are installed correctly,
 check correct connection to all necessary utilities and energy supply lines;
 check the unambiguous identification (labeling etc.) of all separate parts of the equipment (valves, sensors,
control devices, etc.),
During IQ the equipment does not need to be turned on, therefore IQ is possible to perform also in the absence of
supply of utilities and energy.
Installation Qualification refers to units and components of the system which are capable do influence directly or
indirectly on quality and safety of the product which is defined by GMP guidelines and already performed GMP Risk
Analysis. All other units and components of the system will not be tested in the course of current IQ tests.
The Protocol includes general description of Installation Qualification (IQ) steps, list of participants, checklists for
separate IQ tests and fields for recording the test results, list of deviations and Installation Qualification Summary
which represents successful implementation of Installation Qualification. The cover page includes a table of approval
of Installation Qualification Protocol (the upper table) and a table of approval of Installation Qualification Report (the
lower table).
Copies of documentary evidence (certificates, etc.) are attached to the Protocol or reference is given to their storage
place.
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)
3 Equipment / System Description

Purified Water (PW) generation, storage and distribution system consists of the following main components:
 Water preconditioning system:
 Filter with automatic back-washing
 UV-Lamp
 HYPD dosing station
 Automatic softener BWT Rondomat E 90 DWZ 200
 Testomat hardness control
 Residual chlorine sensor
 SH700 dosing station
 NaOH dosing station
 pH, Redox measuring sensor
 Break tank with level control, 2000 L
 First elevation pump
 Purified Water generation system Septron HPW 50, 1450L/h (See separate qualification protocols)
 Purified water storage system
 Storage tank, 4500L
 Inlets for filling, air filter and water return
 Automatic level control using differential pressure, output 4-20 mA
 Vent filter with heated housing
 Spray ball
 Safety membrane
 Distribution loop:
 Loop pipeline
 Pump, tri-clamp connection, frequency regulator
 UV-Lamp
 Heat exchanger for water cooling and heat sanitization
 Sampling valves
 Flow meter
 Pressure gauges, thermometers
 Conductometer, TOC
 Control panel with a display and keyboard
Purified water system will be used for the preparation of Purified Water according to Pharmacopoeia, with a storage
and distribution loop.
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)
4 Installation Qualification (IQ) Execution
4.1 Requirements
Before execution of Installation Qualification (IQ) the following requirements should be fulfilled:
 Design Qualification (DQ) has been successfully performed by checking system specifications against URS
and requirements identified during Risk Analysis (RA).
 Installation Qualification Protocol is checked and approved by authorized participants, table of approval of
Installation Qualification Protocol (the upper fields with signatures) on the cover page is filled in.
 All the documents listed in 1.3 are present.
 At least two of participants taking part in Installation Qualification are present.
4.2 Installation Qualification (IQ) Procedure
During Installation Qualification equipment is checked step by step in accordance with the procedure described in the
corresponding control sheets. The results of each test and comments are filled in the corresponding control sheet.
If any deviation is detected it should be described exhaustively but briefly in the field for comments on the control
sheet. These deviations are also recorded in the separate List of Deviations that is attached to this Protocol as Annex
1.
The data inserted into any control sheet or any field should be confirmed with the signature and date. The data should
be filled in using ball pen of blue or purple color.
Use of eraser or correction fluid is forbidden. Any corrections are made by striking the old record out and creating a
new record next to the old one. At the same time deleted record should remain readable. Each correction should be
accompanied by the signature of the person who did the correction and the date.
Any changes in formulation of acceptance criteria or instructions how to perform testing are not acceptable since the
moment the Protocol was approved for execution.
4.3 Working with documents
During control of equipment according to documentation provided by supplier (Piping&Instrumentation Diagram

(P&ID), Component List, I/O List, Alarm List, etc.) color highlighting is used. Copies of the corresponding document
are marked with color highlighters:
 Green, if component/function conforms to the documentation
 Red, if component/function does not conform to the documentation (a record in the list of deviation is made)
 Yellow, if it is not possible to check conformity / additional control is needed (in this case a record in the list
of deviation is also made).
When the control is completed the copy of the document with color highlighting is signed and dated. The document is
registered in the list of Appendices and is attached to the current Protocol.
4.4 Completion of qualification / Approval of the documentation
When all tests are completed Installation Qualification Summary is filled in where the success of Installation
Qualification is evaluated. . Operational Qualification Summary is attached to this protocol as Annex 2.
Installation Qualification is considered as successful if all acceptance criteria in all control sheet are met, or all
detected deviations are eliminated (or declared to be inessential, which should be substantiated by quality assurance
commission).
Final settlement of any nonstandard situations or deviations related to Installation Qualification, and also approval of
the IQ Protocol and IQ Report should be performed by the Leader of Validation Team of the enterprise, whose
functions could be done by different participating top managers, typically Quality Assurance Department Manager.
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)
5 Installation Qualification (IQ) Participants

The specialists responsible for preparation, check and approval of the current IQ Protocol / IQ Report put their
signatures in the corresponding chapter on the cover page.
In the table below the specialists directly participating in testing according to the current Installation Qualification
Protocol:
No. Name Function / Company Sample of the signature

1.
2.
3.
4.
5.
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)
6 List of Measuring Instruments Used in IQ

Measuring instruments used during Installation Qualification should have valid verification certificate.
In the table below all measuring instruments are listed. Copies of verification certificates should be attached to the
current Protocol.
No Instrument ID Number Date of Date of the

verification, next
Certificate verification
Number
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)
7 Installation Qualification Control Sheets
7.1 IQ-1. Documentation
Control Sheet No. IQ-1

Test: Control of presence of technical documentation for the equipment
Purpose:
To confirm the presence of technical documentation required according GMP guidelines, such as technical drawings,
P&IDs, certificates of materials, user and maintenance manuals, lists of spare parts, etc.
Availability of calibration certificates is checked in Chapter 7.
Method:
Inventory of the documentation.
Copies of documents should be either attached to this protocol, or reference should be given in the Comments field
to their storage place (folder name etc.).
Acceptance criteria:
Presence of all documentation listed in the table below.
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)
Control Sheet No. IQ-1.1

Results:
Control Document Present Signature Date

point Yes/No
No.
Purified Water (PW) pre-treatment system:
1.1.1 Technical specification
1.1.2 P&ID
1.1.3 Component list, incl. specification
Comments:
Please see separate qualification protocols for Purified Water generation system Septron HPW 50, 1450L/h
ARE ACCEPTANCE CRITERIA MET? (Yes/No)
IF NOT, PLEASE SPECIFY THE POINT NUMBER IN THE

LIST OF DEVIATIONS:
Signature:................................................................................. Signature:........................................................................
Date:......................................................................................... Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Results:

point Yes/No
No.
Purified Water (PW) storage and distribution system:
1.2.1 Technical specification
1.3.2 P&ID
1.2.3 Component list, incl. specification
1.3.4 Equipment layout drawings
1.2.5 Specification of electrical equipment
Electrical diagram
1.3.6 Material certificates for all product-contact or
otherwise critical parts are available,
corresponding check protocol is attached.
1.2.7 Surface roughness certificates for all product-
contact or otherwise critical parts are available,
1.3.8 Welding documentation for all product-contact
or otherwise critical parts is available,
1.2.9 Pressure test protocol for PW storage and
distribution system
1.2.10 Pressure test protocol for Heat Exchanger
Comments:

LIST OF DEVIATIONS:
Date:......................................................................................... Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Results:

point Yes/No
No.
Purified Water (PW) storage and distribution system:
USER / MAINTENANCE MANUAL - contains following information:
1.3.1 Interfaces and necessary signal exchange with
other systems
1.3.2 Program sequences / parameters, dedicated
for the different procedures; different programs
are defined, dedicated to operation, cleaning
and sanitization
1.3.3 User Access is divided into three groups with
password: operator, shift manager, service
engineer.
1.3.4 Interface of the system is in Russian language.
1.3.5 List of alarms (including light alarms, horn etc.)
1.3.6 List of all process relevant parameters incl.
related programmed limits
1.3.7 The following data are displayed at HMI:
 In operation
 Current program / sequence
 GMP relevant data
 Operation malfunctions / alarms
 End of program / cycle
1.3.8 Operator settings stay unchanged and restored
after emergency stop / power failure; Alarm
message after restoring power; Appropriate
system for prevention of uncontrolled process
after power failure is planned.
Comments:

LIST OF DEVIATIONS:
Date:......................................................................................... Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)
7.2 IQ-2. System Technical Characteristics

Test: Control of type and general technical characteristics of installed equipment
Purpose:
To confirm that type, main technical characteristics and identification data of installed equipment (main units)
conform to the specifications.
Method:
Equipment inventory according to the table below.
Conformity of all characteristics of equipment to those listed in the table below:
- Type of equipment
- Identification data
- Main technical characteristics
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Results:
Control Parameter Conforms (Yes/No) Signature Date

point
No.
Dosing Station (HYPD):
2.1.1 Presence of the factory plate
2.1.2 Type – Medo G + Teleskop Medo II Gr.1
2.1.3 Year of manufacture –
2.1.4 Serial Number –
Dosing Station (SH7001;DCL30):
Dosing Station (NaOH):
Comments:

LIST OF DEVIATIONS:
Date:......................................................................................... Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Results:

point
No.
Automatic Softener :
2.2.2 Type – BWT Rondomat E 90 DWZ 200
Comments:

LIST OF DEVIATIONS:
Date:......................................................................................... Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Results:

point
No.
Hardness control unit :
2.3.2 Type – TESTOMAT 2000 + SK910
Comments:

LIST OF DEVIATIONS:
Date:......................................................................................... Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Results:

point
No.
Purified Water (HPW) storage tank:
2.4.3 Serial number –
2.4.4 Volume – 4 500 L
2.4.5 Working temperature max – 90°C
2.4.6 Calc. pressure, gauge – from -1 to +0,5 bar
2.4.7 Appearance / presence and location of units of
the machine conforms to the layout drawing
Comments:

LIST OF DEVIATIONS:
Date:......................................................................................... Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)
7.3 IQ-3. Instrumentation

Test: Control of Installed Instrumentation
Purpose:
To confirm conformity of type, correct installation, absence of any damage and correct identification of system
components.
Method:
Inventory of actually installed equipment according to P&ID and component list.
The check is performed for Purified Water (PW) generation, storage and distribution system.
AC1: Installation is done according to P&ID.
AC2: Type of the component conforms to the specification (component list).
AC3: Proper quality of installation and absence of any visible damage.
AC4: Presence, correctness and readability of component’s labeling - labeling is in easy accessible place, resistant
towards working environment, all the components have unique identifiers.
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Results:
Control Component Description AC1 AC2 AC3 AC4 Signatures Date

point code
No.
3.1.1 201 Backwash filter
Infinity M 1"
3.1.2 202 UV Lamp
Bewades
212 80W80/11
Break tank LC
3.1.3
3.1.4 213 Booster Pump
3.1.5 FI-274 Aspirattion filter
3.1.6 HEX-275 Heat exchanger
3.1.7 P1.201 Manometer
3.1.10 V1.213 Return valve

AC4: Presence, correctness and readability of component’s labeling.
Comments:
IF NOT, PLEASE SPECIFY THE POINT NUMBER IN

THE LIST OF DEVIATIONS:
Signature:.................................................................................
Signature:........................................................................
Date:.........................................................................................
Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Results:

point code
No.
3.2.1 PU-272 Booster Pump
3.2.2 SIC-2721 Frequency

converter
3.2.3 UV-273 UV-lamp
3.2.4 TOC-276 TOC
3.2.5 PI-2706 Manometer with

diaphragm seals
3.2.6 PI-2741 Manometer with
diaphragm seals
3.2.7 PI-2756 Manometer
3.2.8
PI-2758 Manometer
3.2.10 V1.213 Return valve

Comments:

Signature:.................................................................................
Signature:........................................................................
Date:.........................................................................................
Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Results:

point code
No.
3.3.1 TI-2755 Thermometer
3.3.4 TOC-276 TOC
3.3.5 CV-2754 Check valve
3.3.8
CV-2753 Check valve
3.3.9 ST-2751 Ball float steam

trap
3.3.10 ST-2752 Thermostatic
steam trap
Comments:

Signature:.................................................................................
Signature:........................................................................
Date:.........................................................................................
Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Results:

point code
No.
3.4.1 ST-2753 Thermostatic
steam trap
3.4.2 YS-2751 Filter
3.4.5 SG-2751 Sight Glass
3.4.6 PSV-2751 Safety valve
3.4.7 АЕ-206 Residual Chlorine

sensor
3.4.8
АЕ-211 Redox sensor
3.4.9 LIT-121 Pressure sensor
3.4.10 LS-2702 Level sensor

Comments:

Signature:.................................................................................
Signature:........................................................................
Date:.........................................................................................
Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Results:

point code
No.
3.5.3 TT-2704 Temperature

sensor
3.5.4 TE-2709 Temperature
sensor
sensor
3.5.6 PE-2707 Pressure sensor
3.5.8 Conductivity
AE-2710
sensor

sensor
sensor
Comments:

Signature:.................................................................................
Signature:........................................................................
Date:.........................................................................................
Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Results:

point code
No.
3.6.1 P2.201 Pressure sensor
3.6.2 FT-2753 Flowmeter
3.6.3 V1.201 Plastic valve
3.6.8 Diaphragm
V1.212
pneumatic valve
3.6.9 HV-2702 Manual

Diaphragm valve
3.6.10 HV-2703 Manual
Diaphragm valve
Comments:

Signature:.................................................................................
Signature:........................................................................
Date:.........................................................................................
Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Results:

point code
No.
3.7.1 XV-2701 Manual
Diaphragm valve
3.7.2 XV-2706 Diaphragm
pneumatic valve
pneumatic valve
3.7.4 XV-2705/ Diaphragm
XV-2706 pneumatic block
3.7.6 HV-2704 Manual
Diaphragm valve
3.7.7 Manual
SP-2701 Diaphragm
sample valve
3.7.8 Manual
SP-2702 Diaphragm
sample valve
HV-2725 pneumatic block
Comments:

Signature:.................................................................................
Signature:........................................................................
Date:.........................................................................................
Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Results:

point code
No.
Diaphragm valve
XV-2726/ W600 I1L 1507
Diaphragm
3.8.3
W600
ManualI1L 1507
3.8.4 XV-2727
Diaphragm valve
XV-2729/ W600 I1L 1507
Diaphragm
3.8.6
W600
ManualI1L 1507
3.8.7 XV-2730
Diaphragm valve

W600
ManualI1L 1507
3.8.10 XV-2733
Diaphragm valve
Comments:

Signature:.................................................................................
Signature:........................................................................
Date:.........................................................................................
Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Results:

point code
No.
XV-2735/ W600 I1L 1507
Diaphragm
3.9.2
W600 I1L 1507
Manual
3.9.3 XV-2736
Diaphragm valve
Diaphragm valve
Diaphragm valve
pneumatic valve
3.9.8 Manual
XV-2741
Diaphragm valve

pneumatic valve
3.9.10 Manual
SP-2703 Diaphragm
sample valve
Comments:

Signature:.................................................................................
Signature:........................................................................
Date:.........................................................................................
Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Results:

point code
No.
3.10.1 Manual
SP-2704 Diaphragm
sample valve
pneumatic valve
3.10.3 HV-2701 Manual
Diaphragm valve
pneumatic valve
pneumatic valve
3.10.6 XV-2751 Pneumatiс valve
3.10.7 Manual
SP-2704 Diaphragm
sample valve
3.10.8 Diaphragm
XV-2708
pneumatic valve
3.10.9 HV-2701 Manual

Diaphragm valve
pneumatic valve
Comments:

Signature:.................................................................................
Signature:........................................................................
Date:.........................................................................................
Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Results:

point code
No.
pneumatic valve
3.11.5 HV-2754 Ball Valve
3.11.7
TY2751 3-way valve
3.11.8
HV-2752 Ball Valve

Comments:

Signature:.................................................................................
Signature:........................................................................
Date:.........................................................................................
Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Results:

point code
No.
3.12.1 TY2752 Pneumatiс valve
3.12.7
HV-2758 Ball Valve
3.12.8
XV-2771 Ball Valve
3.12.9 HV-215/ Diaphragm

W600 C17 4041
Diaphragm
3.12.10 XV-2713
pneumatic valve
Comments:

Signature:.................................................................................
Signature:........................................................................
Date:.........................................................................................
Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)
7.4 IQ-4. Utilities

Test: Utilities
Purpose:
To confirm presence and correct connection of the system to utilities and power supply sources.
Method:
Check of presence and connection of each line of supply of technological media and power supply listed in the table
below according to P&ID and specifications.
All connections according to P&ID and specifications are present.
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Test: Utilities
Results:
Control Media / power supply Connection Conforms Signatures Date

point (Yes/No)
No.
Purified Water (PW) generation, storage and distribution system:
4.1.1 Power supply 380 V, 3L/N/PE
4.1.2 Compressed oil-free air
4.1.3 Feeding raw water
4.1.4 Chilled water
4.1.5 Plant steam
4.1.6 Drain points according to P&ID
4.1.7 Reserved power supply (GR)
Comments:

Signature:.................................................................................
Signature:........................................................................
Date:.........................................................................................
Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)
7.5 IQ-5. System Compliance to GMP Requirements

Test: Control of compliance of the system to GMP requirements
Purpose:
To confirm compliance of the system to general GMP requirements and the measures defined during conducted Risk
Analysis regarding avoiding product contamination, quality of materials in contact with pure media or product and
possibility of complete emptying of the system and performing monitoring.
Method:
Visual inspection of equipment according to test points described below.
Described in test points in the table below.
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Results:
Control Element / Requirement / Acceptance criteria Conforms Signatures Date

point Parameter (Yes/No)
No.
5.1.1 Piping Horizontal piping has slope of at least 1 degree
(visual check – mark on P&ID).
5.1.2 Piping Complete emptying of the system is possible in
the lowest points of the system.
5.1.3 Piping The 3D (measured from wall of main pipe) and 6D
(measured from center of main pipe) rules are
observed as much as possible. No dead zones.
5.1.4 Piping Walls and false-ceiling crossing holes are
provided with suitable airtight AISI 304L grommets
5.1.5 Piping Pipelines and the equipment with a temperature
below 15С have thermal insulation
5.1.6 Valves Valves in lines which are in contact with the
product or with pure media are of secure hygienic
type (membrane valves).
5.1.7 Valves All GMP-critical valves are equipped with optical
or electric position indication.
5.1.8 Welding Orbital welding in inert environment (argon) used
as a standard welding technique. Gas certificate is
available.
Check of 10% of orbital welded and 100% of
handmade seams by endoscope (especially after
sterile filter). Test points must be defined, photos
attached to the protocol.
All seams are traceably documented.
Welding samples are available.
5.1.9 Welding Welded seams are smoothed outside out to the
base metal.
Comments:
IF NOT, PLEASE SPECIFY THE POINT NUMBER

IN THE LIST OF DEVIATIONS:
Signature:.................................................................................
Signature:........................................................................
Date:.........................................................................................
Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Results:

No.
5.2.1 Points of use No direct connection to pressurized
process lines at user points. Tanks are
supplied from the top (tanks act as air-
breaks). Automatic, normally closed
membrane valves, 3D rule.
5.2.2 Drains Drain from the tank and piping which are in
contact with pure media is done with air-
gap.
5.2.3 Connections In lines which are in contact with clean
media all the connections are of hygienic
type (welding and hygienic flanges,
absence of threaded couplings).
5.2.4 Utilities Connection to utilities carried out by means
of demountable connectors.
5.2.5 Sensors Positioning of sensors should allow easy
access for maintenance and calibration.
Design should allow performing
maintenance (as far as possible) and
calibration without emptying of equipment /
loop.
5.2.6 Primary Protocol of primary cleaning / passivation of
cleaning / the system is available.
passivation of The protocol includes a proof of water
the system quality after cleaning / passivation.
5.2.7 Signs / All signs / labeling / manuals and
labeling / instructions are in Russian language.
documenta- Pipes are labeled with content and direction
tion of flow.
Comments:

Signature:.................................................................................
Signature:........................................................................
Date:.........................................................................................
Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Results:

No.
5.3.1 First wetting First wetting of system units only short
of the system before commissioning (or other
appropriate measures). If wetted,
thorough drying / conservation before
dispatch. Protocol provided.
5.3.2 Storage Tank At least one spray ball has to be
available (visual check). Complete
wetting of the tank surface must be
guaranteed*.
5.3.3 Sanitization of Sensor installed in “coldest spot” –
loop typically furtherest point from heat
exchanger exit (near entry to heat
exchanger).
5.3.4 Sanitization of Heat insulation installed
loop
5.3.5 Sanitization of Installation allows thermal expansion
loop movements
5.3.6 UV Sterilizer Hygienic design of UV-sterilizer (3D/6D
rule, drainability, materials, surface
quality, cleanability).
5.3.7 Sanitization of Has timer with alarm (minimum), limits
PW must be defined.
generating
unit
Comments:

Signature:.................................................................................
Signature:........................................................................
Date:.........................................................................................
Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Results:

No.
5.4.1 Quality of Steel grade (AISI 316L for parts with media
Materials contact, AISI 304L for others) and surface
roughness (0,8 µm) of metal components
conform to the requirements
(certificates/protocols).
Factory labels are available.
3.1 certificates according to EN 10204 are
available.
5.4.2 Quality of Material of polymer sealing conforms to the
Materials requirements (FDA certificate is present).
5.4.3 Lubricants All product (possible) contact lubricants
conform to 21CFR §178.3570 or equivalent
5.4.4 Recording Recording (including event log) is possible, a
printer or registrator with alarm is installed –
check definition in User Manual.
5.4.5 Local The following information available in the
indication production area:
- System in operation / not in operation
(Required information on HMI displays is
listed in 1.3.7)
5.4.6 Sight glasses Made of proper stable material (borosilicate
etc.)
5.4.7 Vent filter Vent filter on storage tank, 0.2 µm, integrity
testable, certificate available
Comments:

Signature:.................................................................................
Signature:........................................................................
Date:.........................................................................................
Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Results:
Control Element / Parameter Requirement / Acceptance Conforms Signatures Date

point criteria (Yes/No)
No.
Position of critical elements:
5.5.1 Flow meters close to the tank and behind
the heat exchanger
5.5.2 Conductivity meter behind the generator
5.5.3 Conductivity meter close to the tank and behind

at the end of the the heat exchanger
loop recycling circuit
5.5.4 Pressure gauge on close to the tank and behind
the reverse branch the heat exchanger
of the circulation
sector
5.5.5 Temperature meter close to the tank and behind
on the reverse the heat exchanger
branch of the
circulation sector
5.5.6 TOC meter starts close to the tank and behind
and ends the loop the heat exchanger
recycling
Comments:

Signature:.................................................................................
Signature:........................................................................
Date:.........................................................................................
Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)
7.6 IQ-6. Control System

Test: Check of control system configuration – hardware and software
Purpose:
To confirm that installed hardware and software conform to the specifications.
Method:
Check for compliance with the specification of labeling and accompanying documents for hardware.
Inventory of hardware and software documentation, installed software version control.
Listed in the table below.
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Test: Check of control system configuration – hardware and software
Results:
Control Description Acceptance criteria Conforms Signatures Date

point (Yes/No)
No.
Purified Water (PW) Storage and Distribution:
Hardware:
6.1.1 Manufacturer Siemens
6.1.2 PLC type S7 V5.5 or later
6.1.3 Control panel Siemens Touch-Panel PC477
6.1.4 Mounting Closed splash-proof electrical cabinet
6.1.5 Power supply 380/220 V, 50 Hz, 3L/N/PE, UPS (GR)
6.1.6 Low voltage power 24 V
supply
6.1.7 Data registration E+H Memograph
Software:
6.1.8 Software Step 7
6.1.9 OS WES 2009 SP3 or equivalent
6.1.10 Interface language Russian
6.1.11 Software Protocol / certificate is available
development
6.1.12 Software Back-up CD is available
installation set
Comments:

Signature:.................................................................................
Signature:........................................................................
Date:.........................................................................................
Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)
7.7 IQ-7. Calibration

Test: Calibration
Purpose:
To confirm that all sensors and measuring instruments are calibrated.
Method:
Visual inspection of calibration labels / control of presence of calibration protocols.
Calibration protocols should be either attached to the current Protocol, or reference should be given in the
Comments field to their storage place (folder name etc.).
Listed in the table below.
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Test: Calibration control
Results:
Control Sensor code Description Calibrated Signatures Date

point (Yes/No)
No.
7.1.4 Manometer with diaphragm

PI-2706
seals
7.1.5 Manometer with diaphragm
PI-2741
seals
7.1.12 TOC-276 TOC

Comments:

Signature:.................................................................................
Signature:........................................................................
Date:.........................................................................................
Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)

Test: Calibration control
Results:
Control Sensor code Description Calibrated Signatures Date

point (Yes/No)
No.
7.2.1 АЕ-206 Residual Chlorine sensor
7.2.2 АЕ-211 Redox sensor
7.2.3 LIT-121 Pressure sensor
7.2.4 TT-2704 Temperature sensor
7.2.5 TE-2709 Temperature sensor
7.2.9 AE-2710 Conductivity sensor
7.2.12 P2.201 Pressure sensor
7.2.13 FT-2753 Flowmeter

Comments:

Signature:.................................................................................
Signature:........................................................................
Date:.........................................................................................
Date:................................................................................
Prepared by: ah
GEDEON RICHTER RUS
Purified Water (PW)
8 Annexes
No. Description Pages Version Date
1. List of Deviations
2. Installation Qualification Summary
Prepared by: ah

IQ PW V03 Gedeon Richter - IQ - PW

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GEDEON RICHTER RUS

Quality Assurance System

GEDEON RICHTER RUS

Protocol Function / Company Name Signature Date

Checked by Quality & validation engineer Alina Lebedeva

Report Function / Company Name Signature Date

1.1 Revision History

Version Date Description of Change

1.3 List of used documentation

No. Name of the document Version Date

3 Equipment / System Description

4 Installation Qualification (IQ) Execution

4.2 Installation Qualification (IQ) Procedure

4.3 Working with documents

During control of equipment according to documentation provided by supplier (Piping&Instrumentation Diagram

4.4 Completion of qualification / Approval of the documentation

5 Installation Qualification (IQ) Participants

No. Name Function / Company Sample of the signature

6 List of Measuring Instruments Used in IQ

No Instrument ID Number Date of Date of the

7 Installation Qualification Control Sheets

7.1 IQ-1. Documentation

Control Sheet No. IQ-1

Control Sheet No. IQ-1.1

Control Document Present Signature Date

ARE ACCEPTANCE CRITERIA MET? (Yes/No)

IF NOT, PLEASE SPECIFY THE POINT NUMBER IN THE

Control Sheet No. IQ-1.2

Control Document Present Signature Date

ARE ACCEPTANCE CRITERIA MET? (Yes/No)

IF NOT, PLEASE SPECIFY THE POINT NUMBER IN THE

Control Sheet No. IQ-1.4

Control Document Present Signature Date

ARE ACCEPTANCE CRITERIA MET? (Yes/No)

IF NOT, PLEASE SPECIFY THE POINT NUMBER IN THE

7.2 IQ-2. System Technical Characteristics

Control Sheet No. IQ-2

Control Sheet No. IQ-2.1

Control Parameter Conforms (Yes/No) Signature Date

ARE ACCEPTANCE CRITERIA MET? (Yes/No)

IF NOT, PLEASE SPECIFY THE POINT NUMBER IN THE

Control Sheet No. IQ-2.2

Control Parameter Conforms (Yes/No) Signature Date

ARE ACCEPTANCE CRITERIA MET? (Yes/No)

IF NOT, PLEASE SPECIFY THE POINT NUMBER IN THE

Control Sheet No. IQ-2.3

Control Parameter Conforms (Yes/No) Signature Date

ARE ACCEPTANCE CRITERIA MET? (Yes/No)

IF NOT, PLEASE SPECIFY THE POINT NUMBER IN THE

Control Sheet No. IQ-2.4

Control Parameter Conforms (Yes/No) Signature Date

ARE ACCEPTANCE CRITERIA MET? (Yes/No)

IF NOT, PLEASE SPECIFY THE POINT NUMBER IN THE

7.3 IQ-3. Instrumentation

Control Sheet No. IQ-3

Control Sheet No. IQ-3.1

Control Component Description AC1 AC2 AC3 AC4 Signatures Date

3.1.4 213 Booster Pump

3.1.5 FI-274 Aspirattion filter

3.1.6 HEX-275 Heat exchanger

3.1.7 P1.201 Manometer

3.1.8 P2.201 Manometer

3.1.9 P1.213 Manometer