My technical internship in Pharma Industry.

1. TECHNICAL INTERNSHIP PROGRAM A033 Sunita Sharma

2. TECHNICAL TRANING IN 2ND YEAR OF
B.PHARM AT KLITCH PVT LTD.

3. TECHNICAL TRANING IN 2ND YEAR OF
B.PHARM AT KLITCH PVT LTD.

4. 1. TABLET MANUFACTURING INDUSTRIAL
PRACTICE: AN OVERVIEW
Ms. Maitri Talati
• Introduction to Pharma Industry- API, Excipients, Bulk Products
• Departments in a Pharmaceutical Industry and their functions in depth
• Types of Modified release Tablets-
Orally Disintegrating Tablets (ODTs), Effervescent Tablet
• Stages of tablet manufacturing and equipment
• IPQC Tests for tablets
• Attented virtual industrial tour of both companies

5. 2. ROLE OF TABLET COATING IN INDUSTRY
Mr. Deepak Singh, Head Technical Sales, Gansons Limited
•Tablet Coating
•Objectives of Coating
•Types of Tablet coating
•Conventional coating plan
•Tablet Coating Equipment
•Coating Process
•The GansCoater
•Important parameters to take care properly-
•Tablet Coating Process and Parameters
•Tablet coating defects

6. 3. INVESTIGATIONAL NEW DRUG
APPLICATION
Mr. Siddarth Singh
•Investigational New Drug application
•Current DCGI
•About CDSCO
•Why apply for NDA
•Steps Involved in Approval Prerequisite
•Different Forms Requirement and Name- Test License, Biologicals, BA/BE for Export
•Milestones
•Expert showed us how to actually apply for IND application through CDSCO Sugam Portal. This knowledge will definitely help
me in real life.

7. 4. R&D ACTIVITIES FOR DEVELOPMENT OF ORAL
SOLIDS
Dr. Agnivesh Shrivastava Regional Technical manager, Gattefosse India
•Individual Department and Role
•Various stages of trials
•Advantages of generic products
•Applications
•Key databases
•Lipid excipients
•I have understood that people are going natural and organic ingridents and excipients are the new trend now.
•This niche segment offers quality excipients, luxury ingrident, and personalized technical support.

8. 5. CLONE DEVELOPMENT AND ADJUSTING TO
LIFE IN INDUSTRY COMING FROM ACADEMIA
Dr. Praveen Rao, Reliance Life Sciences
•Platforms for cell line development- to get proteins expressed in host- E.coli, Yeast, CHO cells
•Features of an ideal cell line
•Current approaches and practices
•Changing trends in cell line development
•The issue of clonality. Clonality is absolutely essential
•Automation is key to cut down timelines in clone development from months to few weeks and sometimes
days.

9. 6. INVENTORY MANAGEMENT,
DOCUMENTATION- SOP & BMR
Assignments
▪Inventory Management: Definition, Objectives, Conponents
I have understood how the raw material is handled and stored for the
pharma production and manufacture with the importance of labelling and
packaging.
▪SOP: Definition, Significance, Components, Common SOPs in
Pharmaceutical Industry
I have understood that key to quality system is having detailed SOPs
▪BMR, Parts, Significance, Numbering system, Preparation, Example

10. 7. PHARMACOVIGILANCE FROM
INDUSTRIAL PERSPECTIVE
Dr. Rahul Somani, ALKEM LABS
•Detailed understanding on the need, aim, framework, Programme, scope, objectives, activities and
components of pharmacovigilance
•I have understood the various methods that I can adopt to report an adverse event
•I have learnt that pharmacovigilance has a lot of scope as it is present in all phases of medicinal product
life cycle to ensure patient safety
•Saw the aim of pharmacovigilance and role of various partners and their role in the pharmacovigilance
programme.
•Understood the need for pharmacovigilance. “Death by disease is inevitable, but death due to medicine
is unacceptable.”
•Understood the framework of pharmacoviligence in risk assessment, people involved, their role and
how data is collected for decision.

11. 8. PHARMA INNOVATION: PERSPECTIVE ON DRUG
DISCOVERY
Mr. Prashant Bhavar
•Product Life Cycle
•Evolution from Chemistry driven approach to Biology driven approach
•The complex pharma network
•Understood the difference in research of generics and New drug development and the IP along with the
government regulations.
•Stages of project selection
•Case Study on Oncology
•Overview of US, Chinese and Indian Biotech Firm

12. 9. GLOBAL STABILITY STUDIES ( DRUG SUBSTANCE
AND DRUG PRODUCTS)
Dr. Ashok Omray Retired Head R&D, USV Ltd
•Why stability studies needed- Signifucance
•Why expiry date is needed? Arrhenius equation.
•Potential risks are associated with expired drugs
•What is shelf life
•Accelerated studies and their significance
•ICH - Q (Quality) – Documents
•Global Stability Protocol, In-use stability, Climate Zones, Testing Frequency, Complete Stability Program
•Bracketing & Matrixing - Reduced Testing

13. 10. OVERVIEW OF DIAGNOSTICS AND MEDICAL
DEVICES
Mr. Ketan Chaudhari, Cipla
•Understanding of the Medical devices sector, its scope and application. Understanding consumables in the medical
industry, its licesnsing and changes in the covid-19 scenario.
•3D Printing and AI role in Medical Device Market for personalising implants according to patient need.
•Majour focus- Biochemistry, Haematology, Immunology.
•Ideal Characteristics
•Include "point of care" (for doctor) and "walk away" tests (home tests)
•types of medical devices.
•Manufacturing, Assembly, Steralisation, Quality lab tests, End customers
•Artificial intelligence is being used for diagnosing

14. 11. VACCINE: A TRANSITION AFFAIR FROM
ACADEMIA TO INDUSTRY
Mr. Nilanshu Manocha
• Vaccine
• Our body's defence system- Innate, Adaptive
• Lab research- Identification of Pathogen and Disease Pathology, In-Vitro
• Preclinical and Clinical Stage
• Manufacturing- upscaling in Bioreactors
• Distribution- Temperature Control and Handling
• Classification of vaccine
• COVID 19 Vaccine Development- Moderna Timeline, Prototype Prepardeness
• New Technologies are Transforming Vaccinology

15. 12. DMPK IN NEW DRUG DISCOVERY
Dr. Jakir Pinjari, Sai Life Sciences
• Hit-To-Lead, Lead Optimization, Candidate Selection, CYP Inhibition Assays in Discovery
• PK/PD Correlation
• Rodent Mini Capsule for salt screening PK in rat
• Alzet Osmotic Pump minimses need for round the clock dosing
• ADME Parameters

16. 13/14- SELECTING ANIMAL MODELS
DURING DRUG DISCOVERY
Mr. Ramnath, Reliance Life Sciences
•What Is an animal model
•Importance of animal models
•Understanding specific objectives to check clinical endpoints assessed- Increases clinical success rates of drugs
in development
•Multiple differences between human and animal models
•Alternative approaches
•Mr. Sameer Shaikh, Reliance Life Sciences
•Preclinical development and Its importance
•Animals used, classification , R & D
•Exposure Concept, Toxicology, and NOAEL

17. 15- QUALITY – GENERAL DISCUSSION ON
“QA AND QC AND INDUSTRY EXPECTATIONS”
Mr. Adil Billimoria (President- Quality and Compliance), Alkem Laboratories LTD
•What is quality
•Quality control and Quality assurance
•Good Manufacturing practices
•QMS - Data Integrity, Audits, Complaints,
Validation, Deviation, Change Control
•Standard Operating Procedure (SOP)
•Drug Regulatory Affair

18. 16/17- PATENTS AND DEMONSTRATION
OF MULTIPLATE READERS
Madhav Kulkarni
•What is patents
•How does it protects
•Conditions of Patentability
•Orange Book, Paragraph IV, Authorized Generics
Neha More, BioTek
•Multiplate readers
•offer flexibility and ease of use over a broad range of applications.
•value for laboratory budgets

19. 18. UNDERSTANDING TABLET TOOLING
Jayendra Patel, R&D Technical Lead – India Region Natoli Engineering Company Inc
•How tablet shape impacts acceptance
•Factors affecting the process
•Punch, Dies
•Types- B,D,BB, DB

20. 19. DATA INTEGRITY IN
PHARMACEUTICAL INDUSTRY
Dr. Adil Billimoria President – Quality & Compliance Alkem Laboratories Limited“
•Importance of Data Integrity- Violations, Enablers, Impact
•Raw data, Meta Data
•Current scenario]
•Documentation control
•Data integrity enablers.

21. 20. RECENT TRENDS IN COSMETIC
FORMULATION DEVELOPMENT
Dr. Shreedevi Shetty, MARICO
•Introduction to the cosmetic industry
•Drift towards sustainability
•Current industry trends
Organic natural skincare
Shift to plant based and organic skincare
Environment friendly
Reduces carbon footprint
• Importance of ethical behaviour towards animals in cosmeceutical industry

22. 20. CLINICAL TRIALS
Dr. Pramod Kashid, Clinical Trial Management-Asia Pacific Medpace Singapore Pte. Ltd.
•Stages of Drug Development
•Accelerated Clinical Development : case study
•Clinical Research: Overview
•Stakeholders
•Departments
•Life Cycle of Clinical Research Project
•Recent Advances
•Impact of Clinical COVID-19 on Clinical Trial Need and Market
•Opportunities

23. 21. TECHNOLOGY
TRANSFER
Chandramani Chandrakar, Cipla
-Key Elements Of Technology Transfer
-Technology Transfer Process Flow Chart
- Scenario Of Technology Transfer
-Lifecycle View Of Control Strategy
-Technology Transfer Team & Responsibility
-Technology Transfer Documenation
-Technology Transfer Checklist
Case Study
-Qbd Approach To Product Development Technology Transfer

24. 22. VARIOUS DEPARTMENTS OF ACG
•What are capsules
•Equipment in the manufacture of capsules- Capsule Checkweighers Packaging Films And Foils Emiity Hard
Capsules Blister Packing Machines Capsule Filling Machines
•Equipment in the manufacture of tablets, Process flow
•Packaging- Role, Level
•Technology
•Track & Trace and Camera Inspection
•Internet of Things

25. 23. REGULATORY OVERVIEW OF
PHARMACEUTICALS
Medical Device by Amit Kumar, Alcon
•Why regulatory affairs?
•Primary roles in regulatory affairs department
•What is a dossier?
•Drug/Device Master File (DMF)
•CTD Triangle for ICH
•IMDRF
•MD Classification

26. 23. OVERVIEW OF F&D AND
PRODUCTION OF COSMECEUTICALS
Dr. Mudra Rathode
•Classification of cosmetics
•Cosmetics vs cosmeceuticals
•Rise of the Korean Skincare and cosmetics industry
•Formulation Development Scientist
•Loreal- Face masks, Clean and clear, Kumar Kajal

27. 24. OVERVIEW OF R & D AND PROJECT
MANAGEMENT
Purnima Warrior
•Typical R&D function
•What is a project
•What is Project Management
•Flow of project management
•Constraints
•Why do we need Project Management
•Gantt chart

28. THANKYOU