Production / Manufacturing Chemist- Life Sciences

CURRICULUM/SYLLABUS

This program is aimed at training candidates for the job of a “Production/ Manufacturing Chemist- Life
Sciences”, in the “Life Sciences” Sector/Industry and aims at building the following key competencies amongst
the learner

1. Knowledge about Life Sciences Industry, and 5. Ability to coordinate with Shift Supervisor, cross
Regulations (cGMP, ISO) to enable him/herself functional teams and within the team for
for establishing the Industry Standards in his/her effective supervision and development and
performance grooming of team
2. Scientific knowledge about Basic of Industrial 6. Ability to ensure all-time audit readiness and
Chemistry for API and Formulation Production, participate in shop floor audits and/ or one-o-one
Production Process for API & Formulations, discussion with auditors as a production team
Equipment and Machinery and how to use them, member and generate the responses for audit
QMS for Production, EHS requirement and queries.
Industrial practices, detailed norms of cGMP,
Quality Risk Management and required
documentation to enable him/herself able to
supervise the Production Process and to enable
him/ her to deal with potential risks and
challenges for quality and data integrity
3. Ability to supervise production process activities 7. Professional Skills like Decision Making, Planning
and how to manage staff and inventory to & Organizing, Customer Centricity, Problem
achieve the Organizational Goals. Solving, Objection Handling, Analytical Thinking,
Critical Thinking
4. Ability to maintain a healthy, safe and secure
working environment at the pharmaceutical
manufacturing shop floor and area around that.
He/ she become capable of managing
emergency procedures.

This course encompasses Three (3) out of Three (3) National Occupational Standards (NOS) of “Production/
Manufacturing Chemist- Life Sciences (LFS/Q 0202)” Qualification Pack issued by “Life Sciences Sector Skill
Development Council, India”.

S. Topic/Module Duration Key Learning Outcomes Corresponding

No (in Hours) NOS Code

1 Orientation 1 To understand Brief outline of Life Sciences LFS/N0203,

Module Industry, its sub-sectors LFS/N0101,
LFS/N0204
1 Brief introduction of Regulatory Authorities and LFS/N0203,
Government Policies, rules and Regulations and LFS/N0101,
their impact on manufacturing in Life Sciences LFS/N0204
Industry in India and Emerging Markets (Both
Regulated and Semi Regulated)

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 4 To understand the Standards for Manufacturing LFS/N0203,
in Life Sciences like cGMP, ISO, etc. Orientation LFS/N0101,
with Pharmacopeia and how to read them. LFS/N0204
2 To Orient with Existing Organisation in Life LFS/N0203,
Sciences Industry (in context of Large/Medium/ LFS/N0101,
Small Enterprises): Their Organization Structure LFS/N0204
and Benefits. Orientation on typical
manufacturing function in a Life Sciences
organization.
2 To understand the Role of a Production Chemist LFS/N0203,
and required skills and knowledge (As per LFS/N0101,
Qualification Pack) and its Career Path LFS/N0204
2. Fundamentals of 8 To have a detailed knowledge about Basics of LFS/N0203
Pharmaceutical Pharmaceutical Science inclusive of Organic
Production Nomenclature System, Organic Reaction
Mechanism, and Basic Chemistry fundamentals
8 To know about Quality Management System for LFS/N0203,
Production in Life Sciences Industry including its LFS/N0204
introduction and importance, QC and QA
Systems, Productivity norms and how to
calculate the overall equipment efficiency
(OEE), Techniques of improving productivity
(Lean and 6 sigma), Techniques to control the
rejects, Quality by Design. Techniques to
control and predict the breakdown, Handling of
market complaints, General introduction about
Deviation ,incident and change control
procedure and Required Documentation
practices by QMS, and its implementation at
shop floor
2 To learn the concepts and practical skills of LFS/N0203,
Quality Risk Management and Data Integrity LFS/N0204
aligned to cGMP in the context of Indian
Culture. To learn the documentation practices
required by cGMP and how to implement these
learnings at shop floor
3 Production Process 8 To have a detailed knowledge of Fundamental LFS/N0203
for API Science in API Production including Size
Separation, Mixing and homogenization
Process, Mass Transfer, Fluid Flow, Heat
Transfer, Size Reduction, Role of API in typical
Pharmaceutical Manufacturing and role of API
particle size in formulations
24 A detailed orientation on Production Process of LFS/N0203,
API with an in depth understanding and LFS/N0101
practical skills on following:
(1) Unit processes: Oxidation, Reduction,
Hydrogenation, Sulfonation, Nitration, and
Halogenation.

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 (2) Bulk organic chemicals as building blocks for
manufacture of drugs and drug intermediates
(3) Catalysis and Bio catalysis in Industrial
production.
(4) Downstream processes like Filtration,
Centrifugation, Extraction, Evaporation,
Crystallization, Drying and Size reduction
(5) Pharmaceutical Manufacturing Equipment’s
(6) Chemical Technologies for selected drugs.
4. Production Process 8 To have a detailed knowledge about Basics of LFS/N0203
for Formulations Formulations including Route of Drug
Administration and Various Dosage Forms like
Oral Solid Dosage, Liquid Oral Dosage, Sterile
Dosage, Dermatological Dosage and their
relevant benefits, Assay calculation procedure
and assay role in formulation, Standard weight
procedure or standard quantity effect in
formulation
12 To learn the conceptual and practical skills LFS/N0203
about Production process of Oral Solid Dosage
including Process of Granulation, Compression,
Coating, Capsule Filling
12 To learn the conceptual and practical skills LFS/N0203
about Production process of Liquid Oral Dosage
covering aspects like:
Types of oral liquids
Types of Monophasic liquid dosage forms
Theoretical aspects of vehicles and additives for
Monophasic liquid oral dosage forms
Mixing processes
Filtration : Definition, theory, filter media,
selection of the filter media and filter aid
Operation, cleaning and maintenance of filter
press
Biphasic dosage forms : Suspensions:
Preparation of suspensions
Types of suspensions
Adjuvants used in suspension, types, selection,
quantity used in formulation
Biphasic dosage forms : Emulsions:
Preparation of Emulsions
Formulation of different types of emulsions
Selection of Emulsifying agents based on HLB
values
Machineries required for preparation of
Emulsions
In process control parameters for Emulsions
Processing of Liquid Orals

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 Operation, cleaning and maintenance of Filling
Lines
Cleaning of manufacturing tanks and validation
of cleaning process.
12 To learn the conceptual and practical skills LFS/N0203
about Production process of Sterile Dosage
covering aspects like:
Definition and scope of Aseptic and terminally
sterilized processing
Water for injection production, testing and
maintenance
Gowning procedures
Good aseptic techniques
Basic microbiology and environmental
monitoring
Sterilization techniques and sterilization
qualification
Operation and maintenance of autoclave
Liquid Filtration and filter integrity testing
Lyophilisation
Manage SIP and CIP processes
Components preparations
Operation and maintenance of Laminar flow
hood
Operation and maintenance of Isolators
Filling of ampoules, vials prefilled syringes, bags
Facility Design and HEPA system
Handle Change Parts- SMED concept
Good documentation practices
Environmental Data trending and excursion
analysis
Testing of ampoules and vials for particulate
matter.
Equipment handling skills used in the Sterile
Dosage production
12 To learn the conceptual and practical skills LFS/N0203
about Production process of Dermatological
Formulations covering aspects like:
Definition of Dermatological products
Classification and types of dermatological
products
Dermatological product formulations
Excipients used in formulation and their
characteristics
Process flow chart
Manufacturing equipment’s and process for
different types of Dermatological products
Filling line equipment’s and processes

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 Cleaning and disinfection of the manufacturing
and filling equipment’s
In process testing for Dermatological
Common manufacturing and filling defects and
trouble shooting
Critical process parameters and critical quality
attributes
5. Supervising a 4 To learn the concept and practical skills for LFS/N0203,
Production Team Production Planning, monitoring shift-wise LFS/N0204
production and required documentation like
scheduled reports, weekly and monthly review
and analysis reports, DPRs etc.
8 To learn the key concept and practical skills for LFS/N0203,
Training, Supervising and delegating & LFS/N0204
monitoring in a manufacturing shop floor of Life
Sciences Industry including the practical use of
psychological concepts
4 Learn the concepts and practical skills for the LFS/N0203,
required documentation in various production LFS/N0204
process. Learn how to check documents like log
book, BMR /BPR, On line documentation
entries. Learn the Concepts of GDP and learn
how to respond to an audit query from QA.
2 Orientation with generic Organizational Policy & LFS/N0203,
various internal Process relevant for Production LFS/N0101,
Chemist LFS/N0204
8 Related Core Skills and Professional Skills: LFS/N0203
Reading, writing, listening and speaking,
Observation & Critical thinking, problem
solving, decision making, customer centricity,
plan and organizing, Analytical thinking,
Execution and Escalation
6. Maintain a healthy, 4 To learn the Basic Concepts of Safety including LFS/N0101
safe and secure Hazards, Accidents, Safety Signs and Signals and
working Henriech Pyramid
environment in the
pharmaceutical
manufacturing
facility
8 To orient with Water Systems at Plant, LFS/N0203,
Engineering related tools and techniques to LFS/N0101
operate the machine safely. Understand the
clean room classifications and requirements,
Knowledge of Clean room behaviour practices
4 To Learn how to use Material Data Safety Sheet, LFS/N0101
Process of Safety Analysis. To orient with Fire
Safety concepts and how to act in case of Fire
Emergency at shop floor. To orient with various
PPEs used in different production operations

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 and to learn how to do Job Safety Analysis for
Various production machines/ equipment and
how to provide these critical information to
concerned team members.
2 To learn the Basic Concepts and practical skills LFS/N0101
for managing Emergency Procedures and how
to do first aid
8 Related Core Skills and Professional Skills: LFS/N0101
Reading, writing, listening, speaking, Plan and
organize, Critical thinking, problem solving,
decision making, customer centricity
7. Coordinate with 6 How to manage Supervisor- Reportee LFS/N0203,
Shift Supervisor, Relationship including how to identify LFS/N0204
cross functional Partnering Opportunities at work; orientation
teams and within on General reporting process, protocol and
the team escalation policy and Importance of reports and
communication with Supervisor including DPR
handover
4 To learn the practical use of techniques for LFS/N0204
Collaborating with Other Groups and Divisions
in order to achieve organizational goals
8 To learn the conceptual and practical skills LFS/N0203,
required by Production Chemist in Audits: LFS/N0204
Importance of cGMP/QMS/ SOP related
documentation
Method to Respond to Audit Queries
How to Face Internal Audit Interactions
Use of IT in communication and coordination
8 Related Core Skills and Professional Skills: LFS/N0204
Reading, writing, listening, speaking, Analytical
thinking, problem solving, decision making,
customer centricity
8. Information 36 Basic Computer Skills (Ms Office, Internet)+ LFS/N0203,
Technology Skills Typing Practice, Use IT Skills at Work. How to LFS/N0101,
use LMIS in a Production plant LFS/N0204
9. Internship 60 To learn the practical skills for instrument LFS/N0203
handling, documentation and supervision
required for API Production
90 To learn the practical skills for instrument LFS/N0203
handling, documentation and supervision
required for Formulations Production
20 Learn how to Maintain a healthy, safe and LFS/N0101
secure working environment in the
pharmaceutical facility of manufacturing
/testing/ analysis / research laboratory
30 Coordinate with Shift Supervisor, cross LFS/N0204
functional teams especially QA, QC,
Maintenance and SCM and within the team

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Total Programme Duration: 430 Hours

(This syllabus/ curriculum has been approved by Life Sciences Sector Skill Development Council.)

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