GSK VEMGAL – User Requirement Specification
Document Title: Facility
Document
STD_00000451809 Version: 1.0
Number:
Function: Facility Site or Site
Department:
Name Role
Content Owner: Steve Foster Capital Project Director
Author: T Suresh Mechanical Lead
Steve Foster Capital Project Director
Sheril Christopher EHS Lead
Reviewed By:
Kaleemulla Koti Technical Lead
Andy Gibson Quality Lead
Approved for Steve Foster Capital Project Director
Release by: Andy Gibson Quality Lead
TABLE OF CONTENTS
1 ABBREVIATIONS ................................................................................................................... 3
2 REFERENCE DOCUMENTS................................................................................................... 3
3 VERSION HISTORY................................................................................................................ 3
4 INTRODUCTION ..................................................................................................................... 4
4.1 Purpose ............................................................................................................................ 4
4.2 Scope ............................................................................................................................... 4
5 SCOPE OF PROJECT ............................................................................................................ 4
6 SYSTEM OVERVIEW.............................................................................................................. 5
6.1 Background ...................................................................................................................... 5
6.2 Project objective ............................................................................................................... 5
6.3 Operational Overview of production facility ....................................................................... 6
7 REQUIREMENTS ASSESSMENT AND TRACEABILITY ....................................................... 7
7.1 CRITICAL QUALITY ATTRIBUTES .................................................................................. 8
7.2 FACITITY REQUIREMENTS ............................................................................................ 8
7.2.1 Manufacturing building ....................................................................................................... 8
7.2.2 General Requirements ..................................................................................................... 11
7.2.3 Environment Health &Safety (EHS) .................................................................................. 11
8 APPENDICES ....................................................................................................................... 12
1 ABBREVIATIONS
Abbreviation Term
PU Poly Urethane
CRP Clean Room Panel
CRD Clean Room Door
NCRD Non Clean Room Door
DQ Design Qualification
PVC Polyvinyl Chloride
CNC
Functional Design Specification
cGMP Current Good Manufacturing Practice
GSK GlaxoSmithKline
IQ Installation Qualification
OQ Operational Qualification
URS User Requirement Specification
2 REFERENCE DOCUMENTS
Ref. Document No. Document Title
1 GQP 4201 Facility Design
2 DG 7001 Internal Building Finishes
3 Version History
Version Revision Reason / Change Request Number Revised by
1.0 Initial version NA
4 INTRODUCTION
4.1 Purpose
The purpose of this User Requirement Specification is to define clearly and precisely, what
the user wants the system to do. It defines the functions to be carried out, the data on which
the system will operate, and the operating environment. It also defines any non-functional
requirements, constraints such as time and costs, and what deliverables are to be supplied.
This User Requirement Specification (URS) specifies the design parameters and lays down
the acceptance criteria, which the defined equipment is expected to meet. Any part of the
supply that does not conform to the requirements expressed in this document must be
brought to the attention of GlaxoSmithKline.
4.2 Scope
This document sets out the Facility user requirements and acts as a schedule of conditions
for the design, construction and delivery. Any part of the supply that does not conform to the
requirements expressed in this document must be brought to the attention of
GlaxoSmithKline.
The purpose of this User Requirements Specification (URS) is to specify the design,
installation and all other relative function and operational requirements for a new
Manufacturing Facility to be located in Vemgal.
The “building and building services design team” shall use this URS as a basis of design, and
transfer requirements as necessary into design and tender specifications.
5 SCOPE OF PROJECT
The facility shall be designed with the concept of separate buildings for each function. This
allows each building structure to act independently to deal with any seismic movement, and
also allows differing structural strategies to be adopted depending on the building functions,
large clear spans to the warehouse and packing hall, smaller modular spans for
manufacturing and offices. The buildings are also extendable to allow individual expansion
of manufacture, packing, warehouse and offices.
The Energy Centre and Training, Recreation, Canteen, Medical Centre are constructed as
fully independent buildings with external access across the site access road. It is envisaged
that the Office building will be single storey and act as the primary admin hub for the site. It
will also form the main visitor access and as such needs to have high quality finishes
internally and externally in line with GSK corporate branding strategy. There is to be a
pedestrian link from the office building to the changing areas for manufacture and packing
with vision panels along its length to allow views into manufacture. The changing area is
effectively a part of the manufacturing building and allows separate change for manufacture
or packing to allow easy segregation of staff into the two use classification areas.
6 SYSTEM OVERVIEW
6.1 Background
GSK plan to build a new solid dosage facility in India, to supply the local market. The
proposed product mix includes compressed tablets and capsules.
The Project shall deliver a solid dose, secondary manufacturing facility in India, capable of
producing 8bn tablets and 1bn capsules per annum and at a cost comparable to CMO’s in
the region. Product transfer phasing will be such as to minimize / eliminate any impact on
the GSK Nashik Site recoveries.
The purpose of this document is to provide a clear and complete statement of the user
requirement for the Facility covering the following:
GMP compliant facility suitable for highly regulated Market.
Grade D and “controlled not classified” (CNC) clean room areas suitable for proposed
products to be manufactured.
Environmental control monitoring systems
Facility optimising flow of personnel and material, with consideration of manual pallet
truck operation
Facility accommodation for manufacturing (process), filling & packaging equipment,
and supporting services and utilities
Provision of short-term staging areas for “work in progress”, and production/packaging
materials and consumables
Maintenance and calibration access
Provision for future expansion of the new facility, with minimal impact on production
operation
6.2 Project objective
Build the first ‘zero’ defect (accidents, defects, waste) factory designed for GPS. Optimised
for flow and inventory
A zero defect factory designed for GPS means the facility when operational will provide the
infrastructure and environment to enable the way we work and behave to drive towards zero
accidents, defects and waste.
The project shall achieve this objective by ensuring the design and build concept details the
equipment and material lot sizes, facility layout and material flow accordingly to minimise
door to door lead time through the factory. Lot size and presentation must also meet
customer value added needs and the supply chain transformation future state.
Specifications and standards of machine and facility to deliver good, defect free
manufacturing performance. This includes ensuring that machine set up and maintenance
requirements are known (documented) and achieved. Also, the project shall achieve this by
ensuring recruitment, organisational design, training, operational ways of working and culture
have the GPS standards at the heart of all design, planning and deployment.
Optimised for flow and inventory means a cadence of manufacture and material flow within
the site is achieved, and a cadence of supply into and out of the site is aligned to the end to
end supply chain cadence and patient consumption.
6.3 Operational Overview of production facility
Shift Working
The factory will operate on a 3 shift, 24hr x 6day basis (only necessary for QC lab to work on
2 shift basis) to achieve 9bn. units per annum
Production Planning & Management
Current proposal is for the factory to implement/use SAP M-ERP from the outset. However,
this is provisional and subject to further project and IT governance discussions and approval.
As a consequence, during Scheme Design, further investigation will be necessary to
understand how M-ERP (or alternatives) will integrate with existing/future commercial and
demand management systems/processes
Manufacturing Processes:
Following is a high-level overview for process flows, manufacturing & packaging equipment
details and specs, etc.:-
Zinetac tablets
API dispensary & excipient dispensary
blender
tablet press
Tablet coaters, FIBC output transfer
Packing line: blister packer, cartonner, case packer
Betnesol tablets
API dispensary & excipient dispensary
Wet granulation solution plant, IBC output transfer
High shear mixer & fluid bed drier, IBC output transfer to
Batch blender
Batch tablet press (x2), FIBC output transfer
Packing line: blister packer, cartonner, case packer
Betnelan tablets
API & excipient dispensaries, IBC & charge bottle output transfers
Wet granulation solution plant, IBC output transfer
High shear mixer & fluid bed drier, IBC output transfer
Batch blender
Batch tablet press (x2), FIBC output transfer to packing lines
Packing lines: blister packer, cartonner, case packer
Copadex, Vibelan, Zevit capsules
API & excipient dispensaries, sieving; IBC, charge bottle & drum output transfers
Dry mill, IBC output transfer (this process phase TBC)
Batch blender, IBC output transfer
Capsule filler, FIBC output transfer to packing lines
Packing lines: blister packer, cartonner, case packer
Warehouse
The factory will have a ‘lights-out’, automated high-bay warehouse with stacker cranes, for
the storage of production materials and finished goods. The warehouse control system shall
be integrated with the MES & M-ERP systems Transfer between the warehouse and
production/packing areas shall be by way of operator-manned pallet trucks (fork-lift trucks will
be avoided, where possible).
7 REQUIREMENTS ASSESSMENT AND TRACEABILITY
In order to distinguish between essential requirements and desirable requirements and to aid
traceability each requirement laid out in the URS must be classified as per the following 4
categories.
Category 1: Critical Requirement
Where the requirement is deemed critical to product quality or equipment operation and
therefore deemed essential.
Category 2: Environmental Health & Safety Requirement
Where the requirement is critical to personnel safety and therefore deemed essential.
Category 3: Optional/Desirable Requirements
Where the requirement is a desirable feature only, has no impact on product quality and
therefore deemed non-essential.
Category 4: Business/Information Only Requirements
Where the requirement is for business use or information only, has no impact on product
quality and therefore deemed non-essential.
For all requirements falling under categories 1 & 2 above traceability must be shown
between the user requirements and the relevant qualification protocols (IQ, OQ etc.). Where
applicable the vendor should respond to all requirements of the URS via design documents
(FDS etc.). The traceability should be completed using a Requirements Traceability Matrix
(RTM). Where applicable, requirements falling under category 3 should be verified via a
commissioning protocol following Good Engineering Practice (GEP).
7.1 CRITICAL QUALITY ATTRIBUTES
The following are the Key Quality attribute
Manufacturing Area Room Finishes
Flooring - Safety Critical
Change rooms
Airlocks – Material air locks and personnel airlocks
Door sizes in Production
Lighting in Production
7.2 FACITITY REQUIREMENTS
7.2.1 Manufacturing building
URS Ref. No. External Category
envelope constructed in reinforced concrete panels, masonry or 3
7.2.1.1
block work, with a render and painted finish
Composite panels for both cladding and roof sheeting, and also 3
7.2.1.2
steel frame construction shall be considered
Framing patterns shall be designed with respect to the process 3
7.2.1.3
function e.g. filling lines, packaging and warehousing areas will
require longer beams spans and larger column centres to provide
maximum flexibility.
7.2.1 Manufacturing building
URS Ref. No. External Category
Roofs shall be designed with a shallow pitch with large 3
7.2.1.4
overhangs to facilitate rapid water shedding during monsoon
weather conditions.
Internal Manufacturing Area Grade D Finishes
Clean rooms shall have traditional clean room insulated High 3
7.2.1.5
Pressure Laminated over Al framework for both wall and ceiling
panels, Coving is to be applied to ceiling / wall / floor
intersections.
7.2.1.6 All equipment and building components within the facility must 1
have surfaces that:
In the clean areas, manufacturing and filling , all exposed
surfaces must be smooth, impervious and unbroken in
order to minimise the shedding and accumulation of
particles or microorganisms and to permit the repeated
application of cleaning agents and disinfectants, where
used.
7.2.1 Manufacturing building
URS Ref. No. External Category
7.2.1.7 Grade D internal finishes shall as follows. 1
Flooring – Floor within the manufacturing areas should be
PU or PU concrete or vinyl or epoxy resin.
Walls – Standard clean room walls panels with composite
construction of 4mm thick two skins of High Pressure
Laminated over Al framework with a sealed and insulated
interior.
Ceilings – Standard Clean room ceiling panels with
composite construction of 4mm thick two skins of High
Pressure Laminated over Al framework with a sealed and
insulated interior.
Doors – A variety of door designs shall be utilised
including hinged, quick acting roller and sliding to suit
each application. Clean room doors are to have flush
cleanable surfaces with viewing panels.
Windows – Windows in graded rooms shall be finished
flush with the wall. Windows between two graded rooms
shall be double glazed to facilitate flush finishing.
Bumper protection/rails shall be considered for high traffic
areas.
Refer Annexure – 1 for Room finishes in Grade D areas.
Clean Room Panels
HPL plastic laminate, pre painted aluminium sheet, plastic 3
7.2.1.8
cobbled or pre-painted steel sheet, stainless steel sheet or
antistatic PVC.
Core material: Expanded polystyrene, mineral wool or aluminium
honey comb. All Panels are provided with a concealed outer
aluminium frame.
7.2.2 General Requirements
URS Ref. No. Construction Requirement Category
Change Rooms and Lockers
Metal Lockers either in a single / 2 or 3 tier arrangement and 3
7.2.2.1
grouped in 'nests' of 2, 3, or 4.
Their normal specification includes locking for security. 3
7.2.2.2
Perforated shelving can be provided if there is a need of 3
7.2.2.3
ventilation
7.2.3 Environment Health &Safety (EHS)
URS Ref. No. Requirement Category
7.2.3.1 Sprinklers in Grade D and packaging area to be considered 2
based on fire load. Sprinklers are envisaged with the technical
spaces.
System to be compliant with the local fire-fighting regulations and
approved by FM Global.
7.2.3.2 For the containment zone, the least clean areas connected by 2
airflow shall be protected from contained material by containment
airlocks at higher pressure to the containment zone
7.2.3.3 Personnel protective equipment, breathing apparatus, emergency 2
showers and spill cleanup shall be provided in, or immediately
adjacent to, the containment zone.
7.2.3.4 A safety potable eye wash units / Eye shower/ Full body showers 2
shall be installed in all areas where chemicals or biological
agents are dispensed or manipulated.
7.2.3.5 Primary and secondary means of emergency egress should be 2
provided for all laboratory areas. The size and number of egress
routes should be determined by an evaluation of the laboratory's
occupancy and hazard.
7.2.3.6 ESD tester shall be provided inside the change room as per the 2
requirement of Process safety study.
8 APPENDICES
APPENDIX – 1
Grade D Room Finishes
Area Description Floor Walls Ceiling Door Windows
Production & Primary Packing areas
Manufacturing/process PU CRP CRP CRD Double glazed Flush type
Areas
Air locks PU CRP CRP CRD Double glazed Flush type
Lobby PU CRP CRP CRD Double glazed Flush type
Emergency shower PU CRP CRP CRD Double glazed Flush type
Corridor PU CRP CRP CRD Double glazed Flush type
Team Room PU CRP CRP CRD Double glazed Flush type
Equip. Technical Area PU CRP CRP CRD Double glazed Flush type
Change Rooms Vinyl Grid Grid CRD/ Double glazed Flush type
Ceiling Ceiling NCRD
Lab areas
Micro Areas Vinyl CRP CRP CRD Double glazed Flush type
Air locks Vinyl CRP CRP CRD Double glazed Flush type
Lobby Vinyl CRP CRP CRD Double glazed Flush type
Change Rooms Vinyl Grid Grid CRD Double glazed Flush type
Ceiling Ceiling
Corridor Vinyl CRP CRP CRD Double glazed Flush type
Goods In/out Double glazed Flush type
Process Areas PU CRP CRP CRD Double glazed Flush type
(Sampling)
Air locks PU CRP CRP CRD Double glazed Flush type
Lobby Vinyl CRP CRP CRD Double glazed Flush type
Change Rooms Vinyl CRP CRP CRD/ Double glazed Flush type
NCRD
