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VMP E16 E01 V00
VMP E16 E01 V00
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APPROVAL
Completion of the following signature block signifies the approver has read, understands, and agrees with the content of this
document.
Name
Signature
Date
(dd-mmm-yy)
Signs as having prepared this version of the Commissioning and Qualification Plan (CQP)
Authored by:
George Popa
Referee Technical
Documentation and
Validation
Authored by:
Lucian Groza
Validation Coordinator
Signs as agreeing with the content of CQP, with particular reference to scheduling of the work and documentation requirements,
agreeing to the application of project resources and material, as needed, to fulfil the objectives described, overall executive
responsibility.
Approved by:
Melania Comiati
QC-Analytical Manager
Approved by:
Maria Cosma
QC-Micro Manager
Approved by:
Levente Marton
Engineering Manager
Approved by:
Laurentiu Vegh
Project Manager
Signs as agreeing that the content of the CQP complies with Company Policies and local requirements, agreeing to the application of
QA/Validation resources, as needed, to fulfil the requirements described, authorising the document to be used as the source for the
commissioning and qualification activities described, agreeing system impact assessments rationales.
Approved by:
Sorin Marincat
Quality Manager
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CONTENT
Section Title
Section
Abstract
Project Description
Support Programmes
Reference Documents
Version History
Family Tree
Appendix 1
Appendix 2
Appendix 3
Appendix 4
Appendix 5
Programme
Appendix 6
Documents
Appendix 7
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1.
ABSTRACT
GlaxoSmithKline will formally commission and, where appropriate, qualify facilities and
equipment which together form the project, QC AND ADMINISTRATION FACILITY, located
at Brasov, Romania. The facilities and equipment will be designed and constructed to meet
the regulatory requirements of Good Manufacturing Practice and in accordance with the
GlaxoSmithKline (GSK) Quality Management System.
2.
3.
PROJECT DESCRIPTION
An overview of the project scope is shown by the project family trees (Appendix I). The
following systems are included within this Commissioning and Qualification Plan:
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heat detection units, manual call points, switching systems for disconnecting power
supply to AHUs in the event of detection. The Fire Alarm System conforms to EN54,
BS: 5839 / NFPA 71/72 in respect of design and installation. The system has a
microprocessor-based control and monitoring facility. The function of the system is
its ability to pinpoint location of fault (rise in temperature or detection of smoke) in
the form of Audio / Visual Alarm and Signal, while it exceeds the pre-set limit.
Boundaries : As shown by drawing(s): E06.10
System Title : Access Control - T001
Description : Access control system is provided to prevent unauthorised entry into
the building and to minimise risk of theft. The Access control system is swipe card
based. Card readers shall be programmed to allow authorised entry according to
the level of access permitted to the card user. The locations of access control
systems are marked in the security system layout drawings. The entire system of
Lab & Office building will be hooked up to the existing Centralised PC based system
located in building no. 5. Existing Access control system for building nos. 2, 5, 6, 10
& 11 is connected through RS485 data communication cable to the centralised PC
based system located in building no.5. This will be relocated to the new gate house
adjacent to Lab & Office building. RS485 data communication cables from building
no. 10 and no. 11 shall be connected to relocated Centralised PC based system in
new gate house. Intruder Detection Sensors (Motion and Broken Glass Detectors)
are provided on each window at Ground Floor Level as marked on security system
layout drawings. Existing centralised control Intruder control Security System is
located in the building no.5 and connected to all other buildings through telephone
lines. Since EPABX is being relocated to Lab & Office building and multi pair
telephone cables are being rerouted between buildings accordingly no new
additional / extra cables are required to be laid for this system.
Boundaries : As shown by drawing(s): E04.30; E04.40
System Title : BEMS - T014
Description : The building is equipped with a BMS system which will monitor and
control all the utilities and installations within the building. The system is based on
DDC Technology distributed in the field. Main equipments and installations
controlled by the BMS are: HVAC, CWS, HWS, Compress Air, and Water Treatment
Plant. The system is composed from controllers which are connected in to a main
console PC Station. The PC Station is connected with the actual BMS system from
building 10. The BMS system can be operated via an HMI which allow the user to
modify the set-points, to generate energy consumption reports and program the
work time schedule.
Boundaries : As shown by drawing(s): BMS01; BMS03
System Title : EMS - E459
Description : In the existing arrangement temperature of equipments such as
fridges, incubators and ovens are measured by connecting external temperature
sensors in these equipments and monitoring these temperatures on 6-channel chart
recorders- temperature monitoring systems (TMS). Make and model of the TMS is
JUMO Logoprint 500 which is a 6-channel chart paper recorder for registering the
temperatures on the chart paper. High and low temperature limits may be set in
these chart recorders for providing an alarm output to LED annunciate. TMS and
alarm annunciate are installed in a wall mounted panel. The existing ovens, fridges
and incubators shall be shifted to the new building along with the existing
temperature sensors. In the proposed EMS configuration, the existing TMS, alarm
annunciate along with the wall mounted panels shall be relocated to the new
building. For measuring other environmental parameters of lab like temperature and
humidity two additional nos. of TMS, alarm annunciates and panel shall also be
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installed in the lab. For measuring the temperature and humidity of critical rooms,
sensors with local display shall be installed in the rooms. Sensors shall have inbuilt
transmitters giving standard 4-20 mA output. These transmitters shall be connected
to the TMS. High/ low temperature and humidity limits shall be set in these chart
recorders for providing alarm output to local LED annunciate installed in the labs. In
night times when the room temperatures and humidity are out of limit TMS shall
also give an alarm output to an annunciate which will be installed in New Gate
House. The First Part of the EMS system is design to monitor and record the areas
011, 113, 123, 124, 125,137 and for 5 fridge posted in the areas 124 &137; The
Second Part of the EMS system will monitor and record 22 temperature sensors
posted : 8 sensors on incubators from the room 101; 1 sensor on the incubator from
the room 102. Fridges; 1 sensor in the room 101; 3 sensors in the room 102 and 2
sensors in the room 108; Ovens: 3 sensors in the room 107
Boundaries : As shown by drawing(s):EMS 00.01 & EMS 00.02
System Title : CCTV and Security - T015
Description : Presently the site has CCTV system in existing buildings for Indoor
and Outdoor surveillance. The cameras are connected to a centralised Security
System in Control Room of Building no. 5. This centralised Security System shall be
shifted and relocated in New Gate House adjacent to Lab & Office building. All the
existing cameras are divided in two loops. One loop for Building No. 10 & 11 and
second loop for building 5 &6 and outdoor areas. CCTV system for Lab & Office has
been provided to monitor access into all critical service areas, critical laboratories,
entrance, exits, walkways and passage ways etc. CCTV system has been provided
in the outdoor areas and GF, FF & SF of the Lab & Office building in consultation
with site and the locations of CCTV cameras are marked on the security layout
drawings. This system shall consist of the following:
Pan / tilt / zoom network camera with suitable optical zoom facility & auto focus
lens.
Indoor type domed coloured camera
21 colour high resolution FTL monitor
DC power supply unit if required
RG-59 Co-axial armoured cable.
Clamps / saddles for conduit / cable clamping
All other fittings and accessories etc. including G.I. flexible conduit as required to
complete the system.
Boundaries : As shown by drawing(s): E04.20
System Title : Voice and Data Cabling - I001
Description : Presently site is having centralised EPABX located in building no.5
server room and caters for voice requirements of buildings i.e. 2, 5, 6, 10, 11 & 14.
All buildings are connected to EPABX through multi pair telephone cables. Since
site is planning to shift this server room, this EPABX shall also be shifted along with
other components of server room to the new server room at second floor of Lab &
Office building Existing EPABX is having adequate capacity for new Lab & Office
building after discarding the use in building no. 2, 5 & 6. New multi pair telephone
cable shall be laid from server room of Lab & Office building to building no. 10.
Further distribution of voice network in building no.10, 11 & 14 shall remain same
Boundaries : As shown by drawing(s): E04.10
Branch : Wet Pipework - 1431/9/21
System Title : Heating Hot Water System LTW01 - T016
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Description : 2 Nos. Boilers shall be factory packed unit complete with jacket, gas
and diesel manifold, burner and control mounted and wired. The hot water for
heating coil of AHUs, fan coils, radiators and duct coils will be ensured from branch
2 from hydraulic balancing vessel on heating plant. Steel pipes will be used for the
distribution circuits, with mineral wool insulated with fire protection covering
according FM GLOBAL. The thickness for the insulation is stated in the tender book
for execution, in accordance with the diameter of the pipe. The pipes which will be
mounted in external (terrace and external shaft) will have heat tracing under the
insulation. The distribution of each heating coil of AHU will have isolated valves,
control valves with 2way and motorised actuator, balancing valve and drainage
filters. The risers will be located into the shafts, with drainage and ventilation
facilities. The fan-coils for second floor will be equipped with 2 coils (heating and
cooling), control valves on both coils for the water temperature control, fan with 3
speeds, the necessary control to operate for all the design parameters. The
distribution for radiator will be in two separate main distributions: a distribution for
radiators which function in night time to assure the internal temperature when the
AHUs are shut-down; this distribution will be connected at branch 3 from hydraulic
balancing vessel - a distribution for radiators which function all time in technical
spaces, staircase and toilets. This distribution will be connected at branch 4 from
hydraulic balancing vessel. The radiators will be steel panel with 1 and 2 panels and
four points of connection. The radiators will be installed on the external and internal
walls will have thermostatic valves on supply pipe and hydraulic balancing valves on
return pipe Steel pipes will be used for the distribution circuits, with mineral wool
insulated. The thickness for the insulation is stated in the tender book for execution,
in accordance with the diameter of the pipe. The system is composing from Boilers;
Diesel tank located inside the boiler room shall be provided with pumps and piped
to the boiler. Diesel tank capacity shall be 1000 litres. Heat Exchanger for each
Boiler, Fuel Burning System for each Boiler, Blower for each Boiler, Gas Train for
each Boiler and distribution pumps.
Boundaries : As shown by drawing(s): BV/16/HV/24-IT/IC rev 02; BV/16/HV/37IT/IC rev 01; BV/16/HV/38-IT/IC rev 01; BV/16/HV-IT/IC - 34; BV/16/HV-IT/IC - 35;
BV/16/HV/22-IT/IC rev 02; BV/16/HV/07-IT/IC rev 02; BV/16/HV/07-IT/IC rev 02;
System Title : Chilled Water System CHW01 - T017
Description : The cold water thermal agent at temperature of 7C/12C will be
dedicated product within the cooling water plant placed on the terrace. The cold
water source is made of two compact aggregates with refrigerating cycle with Freon
R134a, having the condensers cooled with air and evaporators / heat exchangers
thermally insulated with mounted refrigerating powers. The cold water (mixture
glycol 45% + water) for cooling coil of AHUs, and fan coils will be ensured by
cooling water plant from terrace. Steel pipes will be used for the distribution circuits,
with rubber closed cell, fibber-free elastomeric foam type Armaflex, with fire
protection covering according FM GLOBAL. The thickness for the insulation is
stated in the tender book for execution, in accordance with the diameter of the pipe.
The pipes which will be mounted in external (terrace and external shaft) will have
protection with galvanized sheet material. The distribution of each cooling coil of
AHU will have isolated valves, control valves with 2 way and motorised
actuator, balancing valve and drainage filters. The risers will be located into the
shafts, with drainage and ventilation facilities.
Boundaries : As shown by drawing(s): BV / 16 / HV / 36 - IT/IC
System Title : Domestic Hot & Cold Water (DCW01 & DCH01) - T018
Description : Design of the water treatment plant shall be proven in practice and
shall be robust and reliable. The plant shall be suitable for continuous duty in an
outdoor location. All pressure vessels shall be designed to withstand maximum
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pressure equal to shut off pressure of the upstream pumps and shall be tested for
130% of this design pressure. All vessels / tanks shall be provided with necessary
manhole/ hand hole and cover. The supports for vessels/ piping, access ladder and
platform with handrails shall be provided for ease of operation and maintenance.
Any coupling, V-Belts, gear boxes and bearings installed shall have a service factor
of 1.5 over motor rated power. All moving parts shall have guards provided. For all
rotating equipment (pumps, blowers etc.) motor speed shall preferably be 1500 rpm.
For all rotating equipment noise level shall be maximum 80 dBA at 1 m distance
from the equipment. All structural/ cable rack within the battery limit shall be
provided by the vendor. Pipe/ cable racks shall run at a height of about 4 metres
from ground level. Battery limit flanges shall be as per ANSI B 16.5 standard, 150
lbs ratings. Minimum thickness of measuring tanks, dilution tanks and non-pressure
parts shall be 6 mm inclusive of 3 mm corrosion allowance. Materials used in the
entire plant shall be compatible with the service and pressure. Pressure gauges
shall be provided at discharge of each pump, blower and inlet/ outlet of each unit of
operation. Sample point shall be provided at inlet / outlet of each unit of operation.
Chemical tanks and storage tanks shall have level indicators (with isolation/ drain
valves) and overflow / drains. Each pump shall have suction isolation valve,
discharge non-return valve and isolation valve. Velocity in unlined pipes shall not
exceed 2.0 m/s.
Boundaries : As shown by drawing(s): BV / 16 / MC / 04 - RW
System Title : Purified Water - T019
Description : Purified Water Storage & Distribution System should be in
compliance with Current US Pharmacopoeia. The system should comprise of SS
316L tank internally electro polished to 0.5micron Ra with shadow free spray balls
(removable type), electrically traced 0.2 micron hydrophobic vent filter, sanitary
grade centrifugal pumps (1 working + 1 spare) with single VFD & UV unit with
intensity monitor. System shall be hot water sanitized at least 80 C at all parts of
the system with electric heaters in break tank. The procedure of sanitization shall be
fully automatic. The pressure in the distribution loop shall always be maintained
above minimum acceptable value i.e. 1.5 bar
Boundaries : As shown by drawing(s):
System Title : Sprinkler System - T020
Description : It is proposed to install a new FM global approved sprinkler system
along with all necessary equipment to provide protection to all the floors in the
facility. The fire protection is designed as per NFPA / FM global guide lines. The new
building is having a large no. of chemicals, reagents & solvents. However the
quantity of such chemicals shall be very small as they shall be used in the Labs for
testing only. Main hazardous material like solvents are being stored in existing
storage area and only small quantity shall be carried to Lab and shall be stored in
fire proof cabinets.
Boundaries : As Shown on Drawing(s) FS-01, FS-02; FS-03; FS-04; FS-05; FS-06;
FS-07
System Title : Drainage - wet (residual water) - T021
Description : The exterior domestic sewerage installation was rated according to
STAS 1795-87 the water debit in each section, taking into consideration the
maximum admitted filling degree, water speed and the normal assembly slope of
the pipe. The diameter and assembly slope for the sewerage pipes results from the
design and hydraulic conditions, the discharge speeds of waste waters must be
higher than the minimum self-cleaning speed and lower than the maximum admitted
speed in the pipes. The slopes and diameters of sewerage pipes will be read in the
column diagrams and in the plans of the sewerage installation.
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building , and sewage network rainwater that takes rainwater from parking areas
and vehicle access through gutters. The surplus water collected from the roof of the
building will be drain in the open gutter near the tank. Rainwater taken from car
access and parking areas will pass through an oil separator type OLEOPATOR - K TN 50 that having a nominal flow of max. 50 l / s and then it will discharge on the
existing gutters. The rainwater sewer pipe network will be plastic, namely PVC-KG /
SN 2 or 4 orange colour code. Buried pipes will be installed on a bed of sand, with
slopes of installation provided in the compliance with drawing parts. Sewerage
networks manholes will be made from plastic, specifically polyethylene, will be
provided with three inlets arranged at angles of 45 degrees and one exit
Boundaries : As Shown on Drawing(s):MC - 01-RS, MC - 02 -RS, MC - 03-RS, MC
- 04-RS, MC - 05-RS
System Title : External hydrants - 1431/9/21/137
Description: The External hydrants system consists of the 4 external Hydrants FM
Global approved and HDPE pipe which will connect the existing Hydrant main ring
to cover the new building
Boundaries : As Shown on Drawing(s):FF - 01
Branch : Dry Pipework - 1431/9/22
System Title : Clean Gases - T023
Description: Gases shall be supplied from pressurised gas bottles located outside
the lab. Material of construction proposed for distribution piping / tubing will be
SS316. Nitrogen is not required by the lab, but has been included as it is required
for blanketing the waste solvent drums. The material of construction of the nitrogen
is carbon steel. Fuel gas will be used as fuel in the Hot Water Boilers. Site has an
existing supply connection in the plot where facility is being constructed. Natural gas
and Acetylene gas pipe supply line shall be provided with flame arrestors and
emergency cut-off devices in case of any fire. Centrally piped gasses will by used
for the following: Argon; Helium, Carbon dioxide, Acetylene & Nitrous Oxide Gas
each will have local filtration prior to point of use
Boundaries : As Shown on Drawing(s): MC -01G; MC -02G; MC -03G
System Title : Compressed Air - T024
Description: 2 No. Air Screw Compressor each of capacity 48 Nm3/hr with after
cooler and all other accessories will be designed as per manufacturers standard
practice. Free Oil Screw Air Compressor will be compact in design. The compressor
will be Air- Cooled. It will be provided with sound proof enclosure, drive motor,
suction filter-cum-silencer system, and after-cooler, moisture separator with trap for
after-cooler, controls and necessary connectors. Motor driver fan will be provided for
ventilation of sound proof enclosure. Compressor will be equipped with efficient
automatic loading/unloading system. The compressors shall start if the pressure
drops below 6.9 bar (g) and stop at 7.4 bar (g). The load / unload mechanism will be
with spring loaded un-loaders. Both compressors will be provided with VFD and
system will be designed to have a common control panel for the operation of the
compressors in parallel to meet the system air requirements. The compressor it will
have a system of cutting down the idling time and stopping the motor whenever
possible to result in energy efficient operations. The noise level has to be restricted
to 80 dBA under free field condition at a distance of 1m from source of the
equipment. In case an acoustic enclosure is necessary, all the instruments mounted
on it will be clearly visible and operable from outside. Pressure Relief Valve set
pressure shall be 110% of operating pressure. The compressor will have a userfriendly microprocessor based control panel to regulate, control and monitor
compressor operation. Bearing hat to be roller type on the drive side and
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combination of ball and cylindrical roller bearings on non-drive side and must be
sealed for life and designed for at least 30,000 hours of operation. The Compress
Air system will be equipped with filtration for removal of oil and moisture, air dryer
and all the measuring instrumentation.
Boundaries : As shown in the drawing(s): MC -01AC; MC -02AC; MC -03AC
System Title : Methane Gas - 1431/9/22/134
Description : According to the enclosed approbations and provisional notifications,
the installation will be built for the afore mentioned building in compliance with the
following: at the property limit, a regulation and measurement post will be placed (in
compliance with detail A), consisting of a RTG320 Dn50 regulator, a G65 volumetric
counter of maximum 100 mc/h and a FGN Dn50 filter; the entire equipment will be
placed in a special metal niche; starting from the regulation and measurement post,
a new 4installation will be executed for use above
ground along the existing parking place on supporting brackets attached to the
metal pillars of the surrounding fence, at a distance of maximum 4.8m; the
installation will thus be assembled on a distance of about 92,0m; then it will cross
the inner yard through the green area at the underground end of the parking lot;
the underground section will be made of PE100 SDR11 Dn110mm, at a depth of
90cm as compared to the ground level, in compliance with the details;
after emerging from the ground, near the fence on the western side of the building,
the new 4 OL installation will be again assembled above ground, on supporting
brackets attached to the metal pillars of the surrounding fence in line with the
building (approximately 30,0m); the new installation will cross the passage between
the property limit (the fence) and the building underground; the section will be made
of PE100 SDR11 Dn110mm in a Tv. OL Dn219mm protection pipe; the end towards
the building will emerge through a support wall which demarcates the passage from
the access area towards the building; after emerging from the ground (support wall),
the new installation 4 OL will cross the circulated area between the protection
wall and the building above ground (the distance between the support points is
2,2m); on the building outer wall, before the installation branches out towards
consumers, a seismic Kas de 4
valve will be assembled, as well as a by-pass with a stop valve; the new installation
will branch out as follows: a 4 sector towards the central heating systems on the
ground floor and a laboratory provided with 2 Bunsen bulbs on the 1st floor, above
the central heating room; a second sector will turn round about the western and
northern parts of the building in line with the laboratory situated on the 1st floor,
which will have another 6 Bunsen bulbs; the assembling of the new installations for
use both on the sides of the building and inside will be accomplished exteriorly, on
supporting brackets (for diameters greater than 2) and on pipe clamps/ bridges (for
smaller diameters) attached to the outer/ inner walls of the building; before the new
installations get inside, each branch will be provided with a fire valve and an
electrovalve directly powered by automatic gas detectors placed inside; the access
to this equipment is granted by a metal fixed staircase assembled in the proximity;
the central heating room will be endowed with air intake directly from the outside, on
an area of 0.2mp,which cannot be closed; burned gas from the central heating will
be removed by means of two 300 mm chimney made of insulated stainless steel,
18m high (up to the building attic); on the first floor, above the central heating room,
the two gas burners will be assembled in two niches provided with the possibility to
remove the burned gas (and the smell); in the other laboratories, another 6 gas
burners will be assembled independently, so that it is necessary to execute two
ventilation holes in the walls/ panes of the building with a view to removing burned
gas/ smells naturally;
all the rooms where methane gas consumers are placed will be provided with
automatic gas detectors with a response of minimum 2% methane in the air, which
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operate on the electrovalves assembled on the new installation outside the building;
Boundaries : As shown by drawing(s): G01.01 rev A, G01.02, G01.03, MG 01, MG
02
Branch : HVAC - 1431/9/23
System Title : HVAC16-01 - T025
Description: The Air Handling Unit No. 1 is designed to serve the rooms: Dining
Hall/ Servery, Food warming area, Store, Food Ent, Dish Wash. The AHU it is a
modulated, horizontal type (supply circuit along to extract circuit) for interior
mounting, FM Global approved double skin, with: Ventilation units 8064 m3/h,
cooling and heating elements, filtration elements and actuating elements. The AHU
is controlled via BMS.
Boundaries : As shown by system drawing(s): BV/16/HV/101
System Title : HVAC16-02 - T026
Description: The Air Handling Unit No. 2 is designed to serve rooms No 20 & 21
(Training Rooms). The AHU it is a modulated, horizontal type (supply circuit along to
extract circuit) for interior mounting, FM Global approved double skin, with:
Ventilation units 4500 m3/h, cooling and heating elements, filtration elements and
actuating elements. The AHU is controlled via BMS.
Boundaries : As shown by system drawing(s): BV/16/HV/102
System Title : HVAC16-03 - T027
Description : The Air Handling Unit No. 3 is designed to serve rooms No 001/
001A/ 002/ 003/ 004/005/ 005A/ 006/ 007/ 009/ 010/ 016/ 013/ 014/ 017A. The AHU
it is a modulated, horizontal type (supply circuit along to extract circuit) for interior
mounting, FM Global approved double skin, with: Ventilation unit 7200 m3/h, cooling
and heating elements, filtration elements and actuating elements. The AHU is
controlled via BMS.
Boundaries : As shown by system drawing(s): BV/16/HV/103
System Title : HVAC16-04 - T028
Description : The Air Handling Unit No. 4 is designed to serve rooms No 011. The
AHU it is a modulated, horizontal type (supply circuit along to extract circuit) for
interior mounting, FM Global approved double skin, with: Ventilation units 3690
m3/h, cooling and heating elements, filtration elements and actuating elements. The
AHU is controlled via BMS.
Boundaries : As shown by system drawing(s): BV/16/HV/104
System Title : HVAC16-05 - T029
Description : The Air Handling Unit No. 5 is designed to serve rooms No 101/ 102/
103/ 107/ 108/ 109A/ 115. The AHU it is a modulated, horizontal type (supply circuit
along to extract circuit) for interior mounting, FM Global approved double skin, with:
Ventilation unit 8726 m3/h, cooling and heating elements, filtration elements and
actuating elements. The AHU is controlled via BMS.
Boundaries : As shown by system drawing(s): BV/16/HV/105
System Title : HVAC16-06 - T030
Description : The Air Handling Unit No. 6 is designed to serve rooms No 104/ 105/
106/ 109/ 110/ 111/ 112/ 113/ 114/ 116/ 117/ 118/ 119/ 120/ 121/ 122/ 126/ 127/ 128/
129/ 130/ 131/ 132/ 133. The AHU it is a modulated, horizontal type (supply circuit
along to extract circuit) for interior mounting, FM Global approved double skin, with:
Ventilation unit 11304 m3/h, cooling and heating elements, filtration elements and
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cast iron. The collection of all AFOS drainage will be made on outside of the
building on designated recipients for disposal. The AFOS units will have on the
working area utilities such purified water and soft water. The extracted air from the
process will be extracted with direct fans integrated in HVAC system and controlled
via VAV devices.
Boundaries: As shown by drawing(s): BV/16/HV/17-IT/IC
System Title : Fume Cupboards - T041-T048
Description : The analytical lab is provided in the processes with 8 cupboards
placed on the lab area. The cupboards are designed to prevent the formation of
dangerous potentially explosive atmospheres and protections from splashes of
hazardous substances in the internal work space. The cupboards will be integrated
in the HVAC system the evacuated air from the cabinets will be extracted with direct
fans controlled via VAV devices. The cupboards will be supplied with utilities such
soft water, compressed air. All the residuals produced in the process will by
evacuated on the general drainage system, system composed from outlet ducts antretur devices.
Boundaries : As shown by drawing(s):BV/16/HV/17-IT/IC
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4.
No Impact Systems
Design Review
Device Assessment
Commissioning Report/Protocol
Commissioning Report/Protocol
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The flow is applicable to facilities, process equipment and control systems with reference to
GSOP 1163 Control System Quality Management System (CSQMS). Embedded control
systems testing may form part of the equipment testing.
The following sub-sections describe the key stages of the commissioning and qualification
exercise.
4.1
4.2
4.3
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4.4
4.5
5.
SUPPORT PROGRAMMES
5.1
SOPs
SOPs will be required to cover the cleaning, operation and maintenance of systems. The
required procedures are identified in Appendix 4. However, it is anticipated that a unique
SOP will not be generated for each system. One SOP may be used to cover a number of
similar systems.
5.2
Training
All staff used for qualification operations will be trained in the appropriate SOPs before the
appropriate stage of qualification commences.
Staff operating or maintaining the equipment will receive appropriate training prior to the start
of cGMP production. Recording of training will be by the use of training record forms that will
reference the content of the training and be signed off by both the trainee and trainer.
5.3
Calibration
Calibration of critical instruments will be performed and recorded according to schedules
using approved SOPs. Critical device assessments will be carried out to determine which
devices require calibration, the accuracy required and the frequency of calibration required.
Planned maintenance procedures will ensure that critical instruments are recalibrated as
required.
Satisfactory completion of the system commissioning and/or qualification protocols will
confirm that the required critical calibrations have been carried out.
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5.4
Maintenance
Preventative maintenance programmes will be prepared for all major items of plant and
equipment. These programmes will be managed by the Engineering Department and will
comprise formal procedures, schedules, methods and records.
Satisfactory completion of system commissioning and/or qualification protocols will confirm
the presence of appropriate preventative maintenance programmes.
5.5
Change Control
Throughout the project life cycle any changes will be managed by project documentation.
A qualified system must not be changed unless a written and approved document authorises
the proposed change. At the end of operation qualification, changes will be managed by the
site change control.
5.6
6.
6.1
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6.2
7.
REFERENCE DOCUMENTS
Reference to specific documents referred to or relied upon by this document are:
Ref.
Document No.
Document Title
GQP1204
GQMP1008
RBR/VMP/V15
8.
VERSION HISTORY
Date
(dd-mmm-yy)
29-Feb-12
Version
V00
Revised By
N/A
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System Title
Assessment
Assessment Rationale
T010
No Impact
T011
Low Voltage
Electrical Power
Distribution
No Impact
T012
Lighting
No Impact
T013
No Impact
T001
Access Control
Direct Impact
T014
BEMS
No Impact
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System No.
System Title
Assessment
Assessment Rationale
E459
EMS
Direct Impact
T015
CCTV and
Security
No Impact
I001
No Impact
T016
Heating Hot
Water System
LTW01
No Impact
T017
Chilled Water
System CHW01
No Impact
T018
No Impact
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System No.
System Title
Assessment
Assessment Rationale
T019
Purified Water
Direct Impact
T020
Sprinkler System
No Impact
T021
Drainage - wet
(residual water)
No Impact
T022
Potable Water
No Impact
1431/9/21/13
3
Technological
Sewage
No Impact
1431/9/21/13
5
Solar Panels
No Impact
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System No.
System Title
Assessment
Assessment Rationale
1431/9/21/13
6
Pluvial Drainage
No Impact
1431/9/21/13
7
External
hydrants
Indirect Impact
T023
Clean Gases
No Impact
T024
Compressed Air
No Impact
1431/9/22/13
4
Methane Gas
No Impact
T025
HVAC16-01
No Impact
T026
HVAC16-02
No Impact
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System No.
System Title
Assessment
Assessment Rationale
T027
HVAC16-03
No Impact
T028
HVAC16-04
Indirect Impact
T029
HVAC16-05
Indirect Impact
T030
HVAC16-06
Indirect Impact
T031
HVAC16-07
Indirect Impact
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System No.
System Title
Assessment
Assessment Rationale
T032
HVAC16-08
No Impact
T035
Lift
No Impact
1431/9/24/11
0
Building
(general)
No Impact
1431/9/24/12
4
Analytical Area
Direct Impact
E16
Microbiological
Lab Area
Direct Impact
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System No.
System Title
Assessment
Assessment Rationale
1431/9/24/12
9
Ground Floor
No Impact
1431/9/24/13
0
First Floor
General Area
No Impact
1431/9/24/13
1
Second Floor
No Impact
System Title
Assessment
Assessment Rationale
T037-T040
Solvent
Benches
No Impact
T041-T048
Fume
Cupboards
No Impact
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System Title
DR
EDR
FAT
Com
IQ
OQ
T010
T011
T012
Lighting
T013
T001
Access Control
T014
BEMS
E459
EMS
T015
I001
T016
T017
T018
T019
Purified Water
T020
Sprinkler System
T021
T022
Potable Water
1431/9/21/13
3
Technological Sewage
1431/9/21/13
5
Solar Panels
1431/9/21/13
6
Pluvial Drainage
1431/9/21/13
7
External hydrants
T023
Clean Gases
T024
Compressed Air
1431/9/22/13
4
Methane Gas
T025
HVAC16-01
T026
HVAC16-02
T027
HVAC16-03
T028
HVAC16-04
T029
HVAC16-05
X
X
X
X
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System No.
System Title
DR
EDR
FAT
Com
IQ
OQ
T030
HVAC16-06
T031
HVAC16-07
T032
HVAC16-08
T035
Lift
1431/9/24/11
0
Building (general)
1431/9/24/12
4
Analytical Area
E16
1431/9/24/12
9
Ground Floor
1431/9/24/13
0
1431/9/24/13
1
Second Floor
IQ
OQ
System Title
DR
T037-T040
Solvent Benches
T041-T048
Fume Cupboards
EDR
FAT
Com
X
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System Title
Operating
SOPs
Cleaning
SOPs
T010
T011
T012
Lighting
T013
T001
Access Control
T014
BEMS
E459
EMS
T015
I001
T016
T017
T018
T019
Purified Water
T020
Sprinkler System
T021
T022
Potable Water
1431/9/21/133
Technological Sewage
1431/9/21/135
Solar Panels
1431/9/21/136
Pluvial Drainage
1431/9/21/137
External hydrants
T023
Clean Gases
T024
Compressed Air
1431/9/22/134
Methane Gas
T025
HVAC16-01
T026
HVAC16-02
T027
HVAC16-03
T028
HVAC16-04
T029
HVAC16-05
T030
HVAC16-06
T031
HVAC16-07
Maintenance
SOPs
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System No.
System Title
Operating
SOPs
Cleaning
SOPs
Maintenance
SOPs
T032
HVAC16-08
T035
Lift
1431/9/24/110
Building (general)
1431/9/24/124
Analytical Area
E16
1431/9/24/129
Ground Floor
1431/9/24/130
1431/9/24/131
Second Floor
System Title
Operating
SOPs
Cleaning
SOPs
Maintenance
SOPs
T037-T040
Solvent Benches
T041-T048
Fume Cupboards
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Sorin Marincat
Melania Comiati
Levente Marton
Csaba Kiss
George Popa
Claudia Pavel
Lucian Groza
OPTIM PM Team
Role
Ensure the activities identified within this plan are carried out to
programme.
Ensure outstanding issues are addressed in a timely and controlled
fashion.
Arrange for commissioning and qualification plans, protocols and
reports to be written by suitably qualified persons.
Approve commissioning and qualification plans, protocols and reports
and all associated amendments.
Approve deviations from pre-approved protocols and decide an
appropriate course of action.
Arrange for commissioning and qualification plans, protocols and
reports to be written by suitably qualified persons.
Verify commissioning and qualification plans, protocols and reports
and all associated amendments.
Review deviations from pre-approved protocols and decide an
appropriate course of action.
Arrange for commissioning and qualification plans, protocols and
reports to be written by suitably qualified persons.
Verify commissioning and qualification plans, protocols and reports
and all associated amendments.
Review deviations from pre-approved protocols and decide an
appropriate course of action.
Write commissioning and qualification protocols and reports.
Supervise third-parties commissioning and qualification activities.
Execute or supervise commissioning and qualification activities
Report imediately deviations from pre-approved protocols.
Write commissioning and qualification protocols and reports.
Supervise third-parties commissioning and qualification activities.
Execute or supervise commissioning and qualification activities
Report imediately deviations from pre-approved protocols.
Write commissioning and qualification protocols and reports.
Supervise third-parties commissioning and qualification activities.
Execute or supervise commissioning and qualification activities
Report imediately deviations from pre-approved protocols.
Write commissioning and qualification plans, protocols and reports.
Review commissioning and qualification protocols and reports issued
by team members (other than QA/Validation).
Review deviations from pre-approved protocols and suggest an
appropriate course of action.
Write commissioning and qualification protocols and reports
Supervise third-parties commissioning and qualification activities
Report imediately deviations from pre-approved protocols
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APPENDIX 6 PROGRAMME
ID
Tas k Nam e
Duration
Work
Start
Finis h
Apr
965 d
1,488 hrs
Sun 02-08-09
Thu 25-04-13
Project start
0d
0 hrs
Sun 02-08-09
Sun 02-08-09
Scope definition
162 d
0 hrs
Mon 03-08-09
Tue 16-03-10
Tue 01-05-12
Design
450 d
0 hrs
Fri 06-08-10
69
PIP approval
276 d
0 hrs
Fri 09-07-10
Fri 29-07-11
81
Permits
217 d
0 hrs
Mon 01-11-10
Tue 30-08-11
116
Procurem ent
580 d
0 hrs
Wed 19-05-10
Thu 09-08-12
243
181 d
1,488 hrs
Wed 31-08-11
Mon 14-05-12
470
164 d
0 hrs
Wed 18-04-12
Mon 03-12-12
706
328 d
707
711
0 hrs
Tue 04-10-11
Wed 16-01-13
80 d
0 hrs
Wed 02-05-12
Tue 21-08-12
162 d
0 hrs
Tue 04-10-11
Fri 18-05-12
Thu 19-04-12
712
Sewage s ystem
5d
0 hrs
Wed 11-04-12
713
5d
0 hrs
Mon 05-03-12
714
Electrical
5d
0 hrs
Mon 23-04-12
Fri 27-04-12
715
5d
0 hrs
Tue 04-10-11
Mon 10-10-11
716
5d
0 hrs
Mon 14-05-12
Fri 18-05-12
717
10 d
0 hrs
Thu 05-01-12
Wed 18-01-12
718
Raw water
10 d
0 hrs
Thu 03-05-12
Wed 16-05-12
719
10 d
0 hrs
Fri 11-11-11
Thu 24-11-11
720
0d
0 hrs
Fri 18-05-12
721
116 d
0 hrs
722
10 d
0 hrs
723
10 d
724
HVAC
15 d
725
BMS
10 d
726
Sewage s ystem
727
728
729
IT
730
Security
731
Electrical
732
Solvent waste
733
734
Solar heating
735
736
737
738
Dies el generator
739
740
741
742
743
Tue 19-06-12
Fri 18-05-12
Tue 27-11-12
Mon 17-09-12
0 hrs
Thu 06-09-12
Wed 19-09-12
0 hrs
Wed 24-10-12
0 hrs
Wed 24-10-12
Tue 06-11-12
10 d
0 hrs
Tue 28-08-12
Mon 10-09-12
10 d
0 hrs
Wed 22-08-12
Tue 04-09-12
10 d
0 hrs
Thu 30-08-12
Wed 12-09-12
5d
0 hrs
Tue 18-09-12
Mon 24-09-12
15 d
0 hrs
Wed 07-11-12
Tue 27-11-12
5d
0 hrs
Tue 06-11-12
Mon 12-11-12
10 d
0 hrs
Wed 22-08-12
Tue 04-09-12
10 d
0 hrs
Wed 22-08-12
10 d
0 hrs
Tue 28-08-12
Mon 10-09-12
5d
0 hrs
Thu 08-11-12
Wed 14-11-12
Lift
5d
0 hrs
Mon 15-10-12
Fri 19-10-12
UPS
5d
0 hrs
Fri 24-08-12
Thu 30-08-12
3d
0 hrs
Fri 24-08-12
1d
0 hrs
Tue 06-11-12
Tue 06-11-12
10 d
0 hrs
Tue 18-09-12
Mon 01-10-12
Raw water
Com misioning finis hed
10 d
0 hrs
0d
0 hrs
55 d
0 hrs
Tue 19-06-12
Tue 27-11-12
Tue 23-10-12
Tue 13-11-12
Tue 04-09-12
Tue 28-08-12
Mon 02-07-12
Tue 27-11-12
Wed 16-01-13
744
10 d
0 hrs
Tue 23-10-12
745
10 d
0 hrs
Wed 24-10-12
Tue 06-11-12
746
Acces control
10 d
0 hrs
Thu 08-11-12
Wed 21-11-12
747
EMS Validation
10 d
0 hrs
Mon 12-11-12
748
15 d
0 hrs
Mon 12-11-12
Fri 30-11-12
749
30 d
0 hrs
Tue 27-11-12
Wed 16-01-13
750
0d
0 hrs
Wed 16-01-13
Wed 16-01-13
Wed 30-01-13
751
Mon 05-11-12
Fri 23-11-12
39 d
0 hrs
Wed 28-11-12
752
5d
0 hrs
Wed 28-11-12
Tue 04-12-12
753
5d
0 hrs
Thu 17-01-13
Wed 23-01-13
754
5d
0 hrs
Thu 24-01-13
Wed 30-01-13
755
Com pletion
0 hrs
Wed 28-11-12
Tue 04-12-12
5d
0 hrs
Wed 05-12-12
Tue 11-12-12
757
107 d
0 hrs
Tue 16-10-12
Fri 22-03-13
778
NDA APPROVAL
112 d
0 hrs
Mon 12-11-12
Thu 25-04-13
782
52 d
0 hrs
Thu 07-02-13
0d
0 hrs
756
791
5d
Thu 25-04-13
Aug
Sep Oct
Apr
2012
May Jun
Fri 09-03-12
Tue 04-09-12
Qualification
2011
May Jun Jul
Fri 19-04-13
Thu 25-04-13
18 May '12
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APPENDIX 7 DOCUMENTS
The following documents must be issued in order to cover all validation activities related to this process:
Document Title
Plan de validare pentru instalatiile de climatizare si ventilatie pentru
blocul 16
Plan de validare pentru cladirea blocului 16
Document Number
VMP/T028/V00
VMP/E16/R01/V00
VMP/T019/V00
VMP/E459/V00
VMP/T001/V01
Under these documents will be developed specific validation documents (URS, design qualification reports,
qualification protocols and reports, traceability matrix etc)