INOTEK

Project Description : Primarily the company is looking to set up a manufacturing site for API products.
The URS template shall be shared wherein all the basic information required for designing a concept
document shall be recorded. Based on this information followings blocks shall be proposed which
includes facility mainly for but not limited to:

 Production unit (Six Blocks)

BLOCK 1 10 Number of reactors with average reactor

volume of 10KL.
Block will be planned with all other accessory
equipment
i.e Centrifuges, Dryers (Rotocone vacuum dryer,
Rotocone vacuum paddle dryers, Tray dryers etc).
The block will have dedicated powder processing
area designated as clean room for Level 3
processing.
BLOCK 2 10 Number of reactors with average reactor
volume of 6.0KL.
Block will be planned with all other accessory
equipment
i.e Centrifuges, Dryers (Rotocone vacuum dryer,
Rotocone vacuum paddle dryers, Tray dryers etc).
The block will have dedicated powder processing
area designated as clean room for Level 3
processing
BLOCK 3 10 Number of reactors with average reactor
volume of 5.0KL.
Block will be planned with all other accessory
equipment
i.e Centrifuges, Dryers (Rotocone vacuum dryer,
Rotocone vacuum paddle dryers, Tray dryers etc).
The block will have dedicated powder processing
area designated as clean room for Level 3
processing
BLOCK 4 10 Number of reactors with average reactor
volume of 3.0KL.
Block will be planned with all other accessory
equipment
i.e Centrifuges, Dryers (Rotocone vacuum dryer,
Rotocone vacuum paddle dryers, Tray dryers etc).
The block will have dedicated powder processing
area designated as clean room for Level 3
processing
BLOCK 5 10 Number of reactors with average reactor
 volume of 1.0KL.
Block will be planned with all other accessory
equipment
i.e Centrifuges, Dryers (Rotocone vacuum dryer,
Rotocone vacuum paddle dryers, Tray dryers etc).
The block will have dedicated powder processing
area designated as clean room for Level 3
processing.
BLOCK 6 This block will be conceptualized as pilot plant.
Block will be planned with all other accessory
equipment
i.e Centrifuges or Nutche Filters/Pressure nutche
filters, Tray Dryers.
It is assumed that the product developed here
will not got for final powder processing &
products will not be used for commercial
distribution. This block will be treated as process
development lab (PD Lab).

DELIVERABLES
1-CONCEPT DESIGN DOCUMENT
Based on the approved layout a concept design document shall be provided which will include

A- Site master plan consisting of

All Six manufacturing blocks
Central Ware house block covering Hazardous & general RM stores with suitable sampling &
dispensing rooms.

Finished goods store.

Drums storage area

Tanks farm area for flammable & non-flammable solvents
Centralized Utility area showing: Boiler house
Chilled water plant
Nitrogen plant
Air compressors
Brine chiller plant
Time office/Guard rooms with suitable frisking area
Weigh bridge
ETP & MEE
Admin block which can be planned in Block 6 (Pilot plant)
QC & QA which can be planned with Block 6 (Pilot plant)
 B-LAYOUT
The layout shall be provided which will be compliant to the approved URS provided by the client.
Individual block layout: Layout plans with tentative equipment placement will be provided for all 6
proposed manufacturing blocks.

Building Layouts will be provided with man & material movements. Hygiene zoning will be done on
layouts showing unclassified & classified areas (Level 3 area) Building Sections: Proposed Block section
will be provided to get an idea of building height. This will be done only for Block 1 & 6. A typical section
is shown underneath.

C- . Production Programme (In Batch/Lot size verification and annual capacity

collaboration with client) verification
D- GMP programme Material Flow concepts
Personnel Flow concepts
Hygiene Zone Layouts
E. Warehouse programme Storage area identification and size calculation.
F. Room and Staff program Basic room book
G.Equipment List Finalization with their capacities
H. EHS & RA (Client have to guide Inotek on local
industrial laws)
I. Preliminary Utility Estimation
J. Project Cost Estimations
K.Project Schedule

Basic engineering
Design Philosophies for

 Civil works

 Electrical Works

 Mechanical Works

 HVAC and Clean room Partitions

 Water Treatment systems

 Fire-fighting systems
 Detailed engineering
CIVIL WORK  Structural Design and drawings which would include -
Inotek shall prepare detailed structural and foundation
design, integrated with Geo-technical work to support:
- Architectural, (e.g. wall, partitions, cladding).
- Civil (e.g, Civil structure, farm, pipe racks, roadways, Utility
Routing and infrastructure).
- Mechanical & Piping, (e.g. Equipment & distribution
system).
- Electrical, (e.g. NEC and model building code requirements
for equipment support).
- Structural analysis and design.
- Excavation Plans and Details
. - Foundation layouts and details.
- Column, Beam Slab Details and Drawings.
- Brick wall and masonry details.
- Staircase details, Etc
.  Plumbing Design and Drawings,
- Drain Point identification and Layout.
- Drain Pipe routings and collection details, Etc.,

- Detailed civil drawings in accordance with anticipated

Architectural Details
permitting requirements.
- Grade infrastructure system.
- Assisting client in the preparation of environmental
permit application.
Inotek will take into consideration the followings points
under the Architectural:
- Detailed Architectural Floor Plans which includes final room
plan, door
- window details with locations, room names and numbering,
room environmental classifications according to European
Standards, wall types and overall dimensions.
- Roof slopes plan, drain location, overflow locations etc.
- Wall and building sections along with elevations drawings. -
Detailed General Arrangement Plans. - Detailed Room
Finishes Details/schedule. - False ceiling. - Schedule for
materials of construction and door sizes, Etc.
Electrical Works: The complete electrical, instrumentation and control
installation will be in accordance with the latest edition and
supplements of the relevant EU and NL standards, codes and
regulations.
 Design Standards for Electricals,
- Design standards covering the basic requirement for
engineering and installation of electrical equipment and list
of standards followed (GES).
 Load Estimation,
- Analysis and computation of loads required.
 Electrical Equipment Specification
- DG & LTPCC panel
- Cables / Wires
- Light Fixtures
- Power switches and sockets, Etc.
 Electrical Installation Specifications,
- Guidance on all installation works and specification for
installation

 Detailed Design / Drawings:

- Detailed single line diagram of power supply
- Cable tray routing drawings including civil engineering data
- Power and earthing layout drawing including location of
electrical equipment
- Layout drawing for the lighting system showing the location
of lighting fixtures and outlets
- Grounding and lightning protection diagrams
- Location plans for plant communication and fire alarm
system
- Arrangement plans for substations
- Riser diagrams for power, security, and fire alarm system.
- Load study, voltage drop analysis and short circuit study.
- Lighting level study and fixture schedule
- Power distribution to the substation and layout. - Main
power and lighting distribution panels.
- Emergency power needs. - Power distribution scheme.
- Motor control centers, panel boards, switchgear additions
and modifications.
- Electrical room layouts.
- Tie in points for power, security, fire alarm and grounding
 UTILITIES - A utility matrix list with all the utilities per room include
their pressure, flow rate, duration of use, pipe size, etc.
- The final copy of the system design theory and operation
will be included for each system.
- Detailed system flow diagrams showing equipment layouts
and distribution network.
- Equipment schedules.
- Plan drawings as required to show main pipe racks and
main piping routing.
- General Arrangement drawings showing all major pieces of
equipment. Sections and elevations will be completed as
required to show clearances.
- Utility studies to include adequacy and routing for steam,
chilled water, fresh water, drains, etc. - Clean utility flow
diagrams.
- Clean utility P&ID’s.
- Site Utility load calculations.
- Utility equipment data sheets if required.
- Utility equipment list.
- Utility systems descriptions.
- Identify special lifting locations and weights, sensitive
vibration areas and piping support requirements to permit
coordination with structural design.
- A process wastewater treatment plant system diagram and
equipment plan

Black Utility Systems:

 Utility Requirement Estimation for various utilities like:

- It is assumed that present boiler capacity is sufficient to cater expansion, following may be required for
PFS line expansion.

- Chilled water

- Compressed Air

Utility Equipment:

- Sizing

- Specification

- Schematics
 Equipment Layout

Mechanical Works:  Piping Specification,

- Specification defining basic piping class specification consisting of
all piping items, valves etc. based on frozen piping specification
 Piping technical specification,
- Specifications defining technical requirements for procurement of
piping items based on frozen piping class specifications.
 Piping support specifications,
- Basic specifications indicating various types of supports, their
nomenclature and specifications component details.
 Insulation specifications - Information indicating the basic
requirements for material and application procedure for:
- Hot and cold insulation.
- Personnel protection.
- This is based on the requirements of material thickness selection
etc.
 Pipe Routing Drawings,
- Overall general arrangement drawing showing the integration of
utility and offsite units with the GA for process areas into the whole
complex.
HVAC Designing of complete HVAC system addressing following key
parameters:
- Temperature
- Humidity
- Cleanliness (Particulate concentration)
- Differential pressures
- Velocities
- Containment
- A listing of the individual mechanical systems with the system load
and sizing calculations will be included as reference. HVAC systems
tabulation will include the system number, horsepower input,
airflows, cooling input, and heating input.
- The final copy of the system design theory and operation. Detailed
flow diagrams showing the area served and air volume and basic
instrumentation.
- Relative room pressurizations and room classifications.
- A floor plan indicating HVAC system boundary lines and air flow
directions between each room. - HVAC system sequences of
operation.
- Equipment schedules will be submitted.
- Plan drawings showing equipment locations and duct runs,
sections and elevations showing clearances.
- An HVAC system failure effects analysis report with redundant
system.
- A mechanical room\mezzanine layout showing a minimum 5’-0
wide, 8’ high service corridor
BMS :  Specifications,
- Control Philosphies.
- Specifications for each of the components like controllers, field
instruments, screen shots, etc.,
 Drawings / Details,
- BMS Schematics
- I/O Lis
 Clean room Partitions

 Technical specification and Drawings,

- Detailed Specifications and drawings for the modular partition and ceiling systems
. Water Treatment systems : Analysis of the Raw water report.
- Estimation of water requirements.
- Water balancing.
- Design of treatment systems and storage systems
Technical specification,
Specification for Generation and Storage Systems.
- Specifications defining technical requirements for
procurement of piping items based on frozen piping class
specifications.
- Pipe Loop Systems.
- Valves and Fittings
Firefighting systems :  Design of Safety System,
- Review and Freezing of design parameters and level of
requirements.
 Locational Drawing / Layout / Details for,
- Smoke Detector and Alarm Systems.
- Heat Detector and Alarm Systems.
- Gas Detector and Alarm Systems.
- Manual Call Points and hooter Locations
.  Cable Schedule and conduits drawing.
 Technical specification
Engineering for Process Equipment  Equipment List Preparing List of all process & utility
equipment required.
URS preparation & floating enquiries.
 Equipment Integration
 Based on the Process Design and equipment list given by
Customer, Inotek would integrate the equipment design in
the Layouts. This includes orientation of the equipment,
foundation details, utility connections and other related
Engineering.
During installation phase, Inotek would make installation
schedule for the equipment including their entry routes into
the building and time schedule of installation.
Project Monitoring Inotek will appoint a Project Manager and a Project
Coordinator supported by relevant Engineering staff at its
offices for design and detailed engineering.
 Project Monitoring for engineering deliverables &
reporting Complete Project Monitoring for Engineering
Deliverables Comprise of: - Project execution procedure
- Project Organization chart
- Project Information and Reporting System The above
information and documents refer only to those services
contracted to Inotek.
 Planning and Scheduling Scheduling and progress control
comprising:
- Preparation of time schedule for the overall project
- Control of project schedule by bar chart.
- Monthly report containing progress curves and short
comment. Schedule evaluation, project control, reporting
refer only to those services which are contracted to Inotek.
 CONSTRUCTION MANAGEMENT (Optional-Not Quoted)
Following are the list of services that we offer under Construction Management Services in Projects. The
nature of activities is as below.
Pre-Construction Activities
Programming & Monitoring
Site Supervision
Meeting & Reporting
Project Co-ordination
Environment, Health and Safety Control
 Participate during design development process and
manage the design deliverables from the consultants and
the concurrence from the client.  Develop overall project
budget in construction with client and consultants.
 Develop a suitable procurement strategy in consultation
with client.
 Manage tendering activities (in co-ordination with client
group) on behalf of the client right from prequalification to
award of works
 In co-ordination with client, prepare a Master Project
Schedule comprising of construction & completion timelines
with clear deliverables.
 Identify all milestones and critical activities.
 Monitor the progress of work in accordance with the
schedule and regularly update it.
 Ensure appropriate supervision of the project from all
agencies concerned. Identify and ensure that all site
problems are resolved by mutual discussion between all
agencies involved. Monitor & resources required and
mobilized at site periodically.
 Establish co-ordination meeting between different
contractors working simultaneously on the project.
 Record all the milestone activities and review defaults
against time plan with reference to the master schedule
through letters and meetings.
 Arrange for site supervision of various activities by a full
time Project Engineer stationed at site.
 The proposed deployment times shall be reviewed time to
time keeping in view the project progress. Adequate
corrective measures shall be discussed and mutually agreed
between Inotek and Client.
 If for any reason resources have to be deployed beyond
what is indicated in the deployment schedule, the duration
& the cost implication of the same shall be discussed and
agreed prior to deployment.
 The deployment shall be strictly as per the attached
manpower deployment schedule which is the basis of this
proposal.
 Convene and Chair all weekly Progress Review meeting
inviting all agencies involved in the project.
 Prepare details minutes of meeting and action report and
circulate to all concerned.
 Perform regular follow up actions and keep the Client
informed of developments
 Carry out constructability review of Good for Construction
Drawing (GFC) issued for construction and issue to
contractors
 Co-ordination with consultants on all technical issues
related to construction on the site & necessary detailing.
 Co-ordination with Clients / Contractors for smooth
functioning of the site works
 Establish and implement EHS procedure at site.  Maintain
 necessary documentation to demonstrate EHS management
on site
Management Information System  Prepare details Monthly Management Information Reports
in respect to time and progress with brief reviews.
Contract Management Review the awarded contract documents and prepare
master program based on deliverables.
 The selected vendor should be with adequate experience
and capacity to organize and supervise construction of
required scale and quality on his / their own. Equipment
mobilization & supervision by contractor’s engineers will
help.
 Certify the running bill submitted by the contractor /
vendors.
 Certify progress claims submitted by the contractor /
vendors.
 Monitor and report on project budget and variation to the
Contracts.
Project Commissioning  Co-ordination commissioning & testing of all works with
Client, Consultants and Vendors.
 Prepare detailed snags and defects list in co-ordination
with the Clients / Consultants.
 Review and certify final bills of all contractors. Contractor
shall submit final bill within one month of completion date.
 Arrange for handover of the premises after operational
tests and commissioning of the services

Validation Documentation Services

Pharma industry is one of the most regulated industry and different countries have their own regulations and standards for
developing, manufacturing, holding and distribution of the Products.

Any manufacturer involved in one or more of these activities have to comply the applicable regulations with respect to the
Good Manufacturing Practices.

Different regulatory authorities have defined the minimum GMP requirements for methods, facilities, controls to be used in the
manufacturing, processing, packaging, holding and distribution of the drug substance/ products.

The requirements are defined specifically in order to assure that, the drug substance/ product meets the requirements of the
Act as to safety, has the identity and strength and meets the quality and purity characteristics that it purports or is represented
to possess.

Following are some references of different regulatory guidelines and/ or regulations that define the GMP requirements for the
manufacturing, processing, packaging, holding and distribution of the drug substance/ products.

-Parts 210 & 211 of CFR 21

- USFDA GMP Commission Directive 91/356/EEC

- EEC WHO Good Manufacturing Practices

The regulatory definition of validation is:

“Validation is an overall term for the establishing of documented evidence through defined tests and
challenges, that a system, manufacturing process, analytical method and / or piece of equipment
meets design criteria and that adequate provisions have been established to keep it in a State of
Control, so it will produce a product that meets pre-determined specifications and quality attribute.”

Methodology Under the scope of these services, Inotek shall follow the
following approach: Inotek uses a multi-task approach to
organize and execute the project.
By breaking the project into individual focused tasks, the
tasks can be scheduled and tracked more effectively.
The organization into tasks does not imply that the tasks are
necessarily sequential; many of the tasks will run
concurrently.
Approximately 2-4 workshops will be conducted at site at
periodic intervals to orient & train the project team on
ongoing Qualification activities. The Tasks include:
 Project Kick off Meeting
 Development of Validation Master Plan
 Preparation of Risk Analysis
 Preparation of DQ Report
 Control of FAT / SAT
 Writing of IQ / OQ as protocols
 Writing Media fill protocols
 Witness the execution and reporting of IQ/OQ protocols
Note: The above tasks are stipulated to utility and facility
only The execution of the pre-approved protocols
documents that the systems and equipment within the
scope of work are installed, function, controlled, and
perform according to the specifications and within the
process parameters.
The purpose and scope of each document are defined on the
following section.
Project Kick Off Meeting Inotek believes that the best way to start a project is with a
Project kick-off.
Meeting will be held between the Client, Inotek and other
involved parties.
The meeting has the following goals:
 Establish a mutually agreed upon mission.
 Establish a clear understanding of roles and
responsibilities.
 Set measurable goals and objectives for the definition of
success.
 Define the actions required to achieve the project goals.
Validation Master Plan Validation Master Plan
The Validation Master Plan is an approved summary
document of the Client. intentions and methods used to
establish the adequacy of performance of equipment,
systems, controls and processes to be validated.
This VMP shall serve to specify and to co-ordinate all
qualification and validation activities required to comply
with the international cGMP-standards.
The VMP programme shall serve to ensure that all
equipment and all applied processes are validated as per
cGMP requirements.
The VMP shall cover the qualification / validation principles
 as well as the design and nomenclature of the
documentation. Furthermore, instructions for approval
procedures of qualification documents are also included.
Project Validation Plans (PVP’s) shall be prepared as
subordinates to the VMP,
which will describe in detail the specific project related to
validation and qualification activities
Protocol Preparation Draft Validation
Protocols Inotek can prepare the bulk of the draft validation
protocols in our office, which keeps the Client expenses
down.
Our preferred word-processing program is Microsoft® Word
for Windows. We will tailor our protocols by incorporating
Client opinion / suggestion / preference / existing format
proposed during the workshop. The protocols (DQs, IQs,
OQs) that are developed for each system shall be defined in
a pre-agreed list of deliverables.
If required, Inotek will use Validation Master Plan and SOPs
of Client to develop the tests and acceptance criteria that
are required for each system. Automation validation is
usually included in the protocol covering the system that has
automation controls.
Protocol Preparation – General
An author having technical familiarity with the type of
equipment involved is assigned the protocol. Before starting
the protocol, the author reads the following documents:
 Validation Master Plan.
 Validation SOPs and Policies.
 Inotek guidance template for the specific piece of
equipment or utility system, if available.
All protocols prepared by Inotek are reviewed and signed by
at least two Inotek employees, before the protocols are
submitted to Client. The review and approval consist of
format, quality and technical review

Protocol Review
Documents Format Review: The author is responsible for the format review. This
involves looking at the protocol for proper fonts, page
breaks, spell check, table of contents numbering, pagination,
etc.
Technical Review: Each document has a technical review.
This review is performed by the Project Manager or
designee of sufficient experience.
It is not expected that the protocol be rewritten or
researched.
The review is for general technical accuracy, and is not
expected to catch subtle differences between similar
systems.
That is the author’s responsibility.
Quality Review: Each document has a Quality review.
This review may be performed by the Senior Staff, the
Project Manager, or a designee of sufficient experience.
The purpose of this review is to verify as best possible that
the tests and data collected will produce a documented
record that the system is what it purports to be, and
operates in a state of control.
 Transmission Once the protocols have been reviewed, they are
transmitted to the Client.
Project Manager as an electronic copy.
Since this phase is designed to incorporate one review cycle,
the Client. shall be requested to compile and assemble all of
the review team's comments into one document, which
then is returned to Inotek. Inotek generates a final version
and submits it to the Client. project manager for final
approval and signatures.
Note: Any further review and revision after first cycle of review shall be charged extra as per the man-
day rates applicable

Installation Qualification Protocol

Inotek reviews the complete system before writing an Installation Qualification protocol to assess the
GMP relevance of each component (mechanical, electrical, instrumental and computer related
components).

Operational Qualification Protocol

OQ Protocols are developed to verify proper equipment operation with functional testing throughout all
anticipated ranges and modes of operation.

The operational tests are designed to challenge and demonstrate the equipment's ability to operate in
accordance with the approved Equipment Specifications.

The Protocol generally contains following tests:
1. Documentation verification e.g. presence of IQ
report, full loop calibration reports and SOPs
identified during risk analysis
2. Start up and shut down tests e.g.
a. Draft SOP verification
b. Emergency shutdown and recovery
c. Sequence testing
3. Automatic / Computerized system tests, e.g.
a. Human Machine Interface Verification
b. Input/output status verification
c. Alarm and Interlock tests
d. User Access Test
e. Verification of configurable parameter
f. Power failure test
g. Real clock verification
h. Verification of interface and communication
4. Equipment specific functional verification
(verification of operational ranges of critical

Control and contact point
Time of notification
Mode of communication
Minor Changes
Major Changes
Change Management
process parameter)
5. Verification of relevant operational parameter
and as identified during risk assessment
Only the project manager of two sides (Inotek & Client)
Within 48 hours of the need realised / anticipated for the
change
Notification to be sent via phone and documented via Email,
fax or letter.
Some changes during the design development phase are
inevitable and can occur due to any of the following reason:-
 Genuine drafting/ typographical errors.
 Change in Regulatory requirements and regulatory
environments.
 Change/ revision of process and process technology.
These changes should be notified and rectified in the earlier
stages of development before commencement of detail
engineering to avoid time and cost over-runs.
Minor changes in the equipment orientation will result in
changing the layout which may have a cascading effect on
other departments of engineering
e.g. HVAC, piping and electrical etc. In this connection only
those changes will be entertained which do not have a
cascading effect and are merely cosmetic (The Project
Managers will mutually decide the effect of the changes).
Re-engineering will only commence once there is a clear
consensus arrived at and additional compensation package
due to Inotek for this change control fixed.
The changes will also include the following (but not limited
to these):
1. Changes caused due to the mistakes made by supplier/
vendor. This is irrespective of whether the supplier has been
pre-qualified by Inotek.
2. Changes caused due to change in technical knowhow.
3. Changes due to regulatory authority guidelines.
4. Changes due to EHS considerations. 5. Force Majeure
Price & Conditions:

FEES :

A. Concept Design: USD 25,000 (Section 3, a & b).

B. Basic and Detailed Engineering: USD 200,000

Payment Terms:

a.Concept Design

100 % Advance payment along with purchase order.

b. Basic and Detailed Engineering

30 %- As Advance along with PO

15 % After Submission of Civil tender

10 % after Submission of HVAC Tender

10 % after Submission of Mechanical Tender

10 % after Submission of Electrical Tender

5 % After Submission of Water system Tender

5 % After Submission of Fire Fighting Tender

10 % Against release of Construction Drawings

5 % against Mechanical Completion of the facility.