COMPLIANCE MADE EASY

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COMPANY OVERVIEW
INCEPBIO AT A GLANCE
✓ IncepBio was founded in the year 2016.
✓ IncepBio was established with a clear purpose: to
assist you in achieving your vision of delivering
high-quality and safe products to patients around
the world.
✓ We bring to the table a collective experience of
over 40 years in the pharmaceutical industry,
making us seasoned professionals in this field.
✓ Our teams are characterized by their dynamism
and versatility, enabling us to adapt effectively to
diverse challenges.
✓ We have successfully addressed the challenges of
more than 100 clients, showcasing our ability to We are the only company to provide End to End
provide effective solutions. integrated services focused on DESIGN, CONSULTATION &
✓ We are an ISO 9001:2015 certified company EXECUTION

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 VISION, MANTRA & CORE VALUES

OUR CORE VALUES

OUR VISION
OUR MANTRA Be Caring
To Assure a Productive
Quality Life Every Day Be Empathetic
Human Life
Be Responsible

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OUR SERVICES
CONSULTING
1. Regulatory Compliance and
Quality Assurance
2. Provide strategic guidance for
2. Customization and Compliance
drug development
3. Enhance efficiency, accuracy,
and productivity
4. Manage data effectively for
decision-making
5. Integrate emerging technologies
for efficiency
6. Identify and implement
innovative solutions
TURNKEY PROJECTS
1. End-to-End Solution
3. Project Management
4. Cost and Time Efficiency
5. Validation and Regulatory
Approval
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CQV, CSV & AUTOMATION VALIDATION AND QUALIFICATION
1. CQV (Commissioning,
1. GMP Compliance
Qualification, and Validation):
a) Systematic approach.
b) Lifecycle perspective.
2. Risk-Based Approach
c) Risk assessment.
d) Documentation and records.
e) Cross-functional collaboration 3. Documentation and Records
2. CSV (Computer System
Validation): 4. Equipment and Process
a) Regulatory compliance. Validation (IQ, OQ, PQ)
b) Data integrity and security.
c) Validation lifecycle. 5. Validation Lifecycle
d) Risk-based approach.
e) Change control
3. Automation:
a) Efficiency and consistency.
b) Data integration and
monitoring.
c) Scalability.
d) Maintenance and validation.
e) Personnel training
INCEPBIO SCOPED PROJECTS MODEL Regulatory
Approval &
Compliance

Build / Construction Qualification-

Pre-CD Commissioning
(Feasibility Study) Design (CD, BD, DD) (Support) Verification Validation

Quality & QMS

Compliance
SOPs

Regulatory Affairs Forms

Records

Facilities & Change Management

Equipment VMP

Process & Utilities

Commissioning
Automation & Construction Support
DQ- Process
Laboratory Controls URS FS DS (RFIs, confirm design- IQ/OQ PQ
RA Validation
System build etc.)

Project & Change

Management

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Engineering Expertise

Multi-Discipline Organization Design Services

• Process: Cell Culture to fill finish, Single-use & Hybrid

• Support Systems: CIP, SIP, process support equipment

• Clean Utilities: WFI, gases

• Plant Utilities & HVAC

MEP:
Process and utilities:
• Automation (PLC, DeltaV etc.) P&ID, PFD
Process Modeling
Pipe routing and layouts
Transfer & Utility Panel Drawings
Line list
•
Valves and Relief Device Sizing
Laboratory controls systems (LIMS, SCADA, PI) Data Sheets Electrical Diagrams0
BOM, Line, and equipment list
• Building Automation System
Architectural & Facility: Instrumentation & Controls:
• Instrumentation & Controls
Room layout
Flows (personal, material, waste)
I/O List and Configuration
Air Supply Diagrams

• Lead equipment, utility system, product and process

Automation: Other Competences Include:

• Good Engineering Guide, Specs, Process Descriptions

Software Architectural Drawings
Hardware/Network Arch Drawings
FS, HDS, SDS, SMDS
• Modelling & Simulation
Technical Specifications Tender
Review and Bid Evaluation
Report
Design Review Workshops
Design Review Report

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COMMISSIONING QUALIFICATION AND VALIDATION
Hybrid Risk based Approach considering CQV Approach
criticality of systems, critical/non-critical components

Historical Paradigm New Paradigm

• Risk Management Tools: SIA, CA, FRA
• Commissioning / Qualification / Validation Master
V-model ( ISPE baseline guide 5)
ASTM E-2500 (ISPE QRM FSE)
ICH-Q9
Plans

• Commissioning Test Procedures Quality System Good Engineering Practice

o Facility, Utilities, Process, Equipment and
Qualify Everything Risk Assessments SIA, CCA
Automation
URS, FS URS, FS, Trace Matrix
• Qualification (DQ/IQ/OQ/PQ) Protocols:
o Critical Utilities Commissioning, IQ,OQ, PQ Verification by SMEs
o Equipment and Instrument
o Process System
o Controlled Temperature Units
o Process Control Systems
o Packaging Lines
o Automation
o Facilities

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VALIDATION

Temperature Validation / Process Validation

Thermal Mapping

Routine validation outsourcing

• Carry both the qualification documentation (IQ, OQ and
PQ) and the temperature, pressure and calibration
tests
• Have all the necessary validation plans, reports, and
SOPs
• Products and processes are customer-fit
Support on-site in projects: Onsite validation services
• Steam and dry heat sterilization processes
• Temperature and humidity mappings
• Cooling and Heating processes
• Freezing and thawing processes
• Specializes in qualification of CIP / SIP system of
reactors, tanks, etc.
Method Validation
• Analytical method validation
• Method transfer
• Validating pharmaceutical and biopharmaceutical
manufacturing processes
• Execution incorporates evaluating the process
capability of the manufacturing and testing
procedures using statistical techniques
• Leachable/extractable by board certified
toxicologist
Cleaning Validation
• CV master plans, cleaning validation protocols,
swab recovery studies and CV SOPs
• Aligning CV with toxicological evaluation to meet
Computer System
regulatory expectations
Validation • Determine the most effective analytical methods
and rationalize the appropriate limits for the
• Integrity of automated processes and Manufacturing acceptance criteria
Systems • Evaluate toxicity of biopharmaceutics, therapeutic
• Electronic data integrity assurance proteins, API and chemicals
• Form complex LIMS application to validate an Excel
spreadsheet

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PROJECT MANAGEMENT

Service Offerings

Skilled PMP Certified Project Managers Certified Scrum Masters Change Records Managers

Change Records Coordinators Traditional Project Management Agile Project Management

Previous Experiences in: Tools Utilized Our PMs Continually Develop Skills in:

• Pharma & Biotech Facility Engineering and Process

• Leadership & Communication

• Facilities/Utilities
• Risk (FMEA etc.) and Quality Management

• IT Software Implementation, Upgrades (SDLC)

• Schedule Management and Tracking

• Automation & IT Infrastructure

• Project Controls

• Manufacturing & Laboratory Systems

• Stakeholder and Vendor Management

• Regulatory Submissions and Remediation

• Change Management

• Research and Development

• Environmental Impact Management
• Resource Planning

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KEY UTILITIES SYSTEM / EQUIPMENT EXPERIENCE

• GMP HVAC Units • Oxygen Microbulk Systems

• Clean Compressed Air Distribution Systems • Nitrogen Systems
• Revers Osmosis / Deionization (RODI) • Compressed Air Systems
Pretreatment/Generation Systems
• Clean in Place (CIP)
• Revers Osmosis / Deionization (RODI) Distribution
• Steam in Place (SIP)
• Tank and Skids
• Process Air Systems
• Water for Injection (WFI) Distribution Tank and Skids
• Process Water Systems
• Pure Steam Generator and Distribution Systems
• Glycol Distribution Systems
• Carbon Dioxide Generation and Distribution
• Systems • Building Management System (BMS)
• Oxygen Microbulk Systems • Building Automation System (BAS)

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KEY PROCESS LAB EQUIPMENT / SYSTEM EXPERIENCE

• Incubators • Osmometers
• Temperature Control Units (TCU) • Floor Scales Blood Gas Analyzers
• LIMS Support and Implementation • Tabletop Centrifuges
• Refrigerators • ph/Conductivity
• Cell Viability Analyzers • Thaw Baths
• Filter Integrity Testers • Biosafety Cabinets
• Spectrophotometers

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KEY QC MICRO LAB EQUIPMENT / SYSTEM EXPERIENCE

• Complete Environmental Monitoring Programs

(EMPQ) Including Room Qualifications, Sample Sites
and Sampling.
• Incubators
• Refrigerators
• Particle Counters
• Air Samplers
• Endotoxin Reader Systems
• Laminar Flow Hoods
• Biosafety Cabinets

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KEY PROCESS SYSTEM / EQUIPMENT EXPERIENCE

• Bioreactors (Single Use and Fixed Piping)

• Cyrogenic Freezers
• Harvest Vessels
• Cold Rooms
• Centrifuges
• Parts Washers
• Single Use Mixing Systems
• ELPRO Monitoring System
• Clarification Skids
• Process Control System (PCS)
• Harvest Tangential Flow Filtration (TFF) • Heat Exchangers
• Ultrafiltration / Diafiltration (UF/DF) Skid (Single • Recovery Vessels
Use, Purification)
• Centrifuges
• Chromatography Skids
• Homogenizer
• Clean in Place (CIP) Skids
• Autoclaves

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STRENGTHS

1. Experienced 2. Efficient 3. Proven

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From Concept to Completion: Our Success Stories

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LEONID CHEMICALS PVT LTD

Laboratory chemical manufacturing company

Design Consultancy Order (Arch & MEP)
Project Value : 27 Lakhs

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SENSES PHARMA

Pharmaceutical Manufacturing
Project Management (Arch & MEP)
Project Value : 12 lakhs

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Sartorius India Private Limited

Life Science Research and the Biopharmaceutical Industry

Turnkey Execution of MEP services
Project Value : 4 Crores

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BIO GENOMICS

Biopharmaceuticals
Turnkey Execution of Civil, Interior's MEP services
Project Value : 9 Crore

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CLIENTELE

The top Brands that witnessed Growth while

working in sync with us

Are you the next one

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 THANK YOU

For more log on to www.Incepbio.com

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