Model Curriculum

QP Name: Chemist Store (Pharma, Biological Products and Medical Devices)

Option:
1.Automated warehouse operations =90 Hours

QP Code: LFS/Q0601
QP Version: 3.0
NSQF Level: 4
Model Curriculum Version: 1.0

Life Sciences Sector Skill Development Council

14, Palam Marg, 2nd Floor Rear, Vasant Vihar, New Delhi, 110057
 Table of Contents
Program Overview .................................................................................................................................. 4
Training Outcomes .............................................................................................................................. 4
Notional Hours Distribution: ............................................................................................................... 5
Details of Modules (Compulsory & Option) and Apprenticeship ....................................................... 6
Compulsory Modules .......................................................................................................................... 6
Optional Modules ............................................................................................................................... 9
Module Details ...................................................................................................................................... 10
Module 1: Introduction to Life Sciences industry and the job role .................................................. 10
Module 2: Managing environmental sustainability .......................................................................... 11
Module 3: Warehouse operations .................................................................................................... 12
Module 4: Inspection of goods ......................................................................................................... 13
Module 5: Reporting and documentation for storage of materials ................................................. 14
Module 6: Disposal of waste material .............................................................................................. 15
Module 7: Coordinate with Manager, colleagues and auditors ....................................................... 16
Module 8: Sensitivity towards all genders and people with disability ............................................. 17
Module 9: Cleaning and Sanitization at workplace .......................................................................... 18
Module 10: Comply EHS rules in GMP/GLP controlled area............................................................. 19
Module 11: Employability Skills (60 Hours) ...................................................................................... 20
Module 12: Preparation for operations ............................................................................................ 21
Module 13: Documentation and quality control .............................................................................. 22
Module 14: Apprenticeship Training ................................................................................................ 23
Annexure 1 ............................................................................................................................................ 24
Trainer Requirements ....................................................................................................................... 24
Assessor Requirements ..................................................................................................................... 25
Assessment Strategy ......................................................................................................................... 26
Annexure -2........................................................................................................................................... 29
Model Curriculum for Employability Skills ............................................................................................ 29
References ............................................................................................................................................ 30
Glossary ............................................................................................................................................. 30
Acronyms and Abbreviations ............................................................................................................ 31

1 | Chemist Store (Pharma, Biological Products and Medical Devices)

 Training Parameters

Sector Life Sciences

Sub-Sector Pharmaceutical, Bio Pharmaceutical, Contract Research

Occupation Supply Chain Management

Country India

NSQF Level 4

Aligned to NCO/ISCO/ISIC Code NCO-2015/4321.0100

NCO-2015/4321.9900
Minimum Educational Qualification and D. Pharma with 1 Year of work experience
Experience or
Graduate in Any Field
or
B. Pharma
or
NSQF Level 3 Certificate of Store Assistant- Life Sciences
with 3 Years of Exp. in relevant field
or
NSQF Level 3 Certificate of Associate- Store (Pharma/ Bio
Pharma / Medical Devices) with 3 Years of Exp. in relevant
field

Pre-Requisite License or Training -

Minimum Job Entry Age 19 Years

Last Reviewed On 28/07/2022

Next Review Date 28/07/2025

NSQC Approval Date 28/07/2022

QP Version 3.0

Model Curriculum Creation Date 18 October 2022

Model Curriculum Valid Up to Date 28 July 2025

Model Curriculum Version 1.0

Minimum Duration of the Course Compulsory Notional Hours

Theory= 210Hours

2 | Chemist Store (Pharma, Biological Products and Medical Devices)

 Practical= 240 Hours
Employability Skills= 60 Hours
Total Compulsory Notional Hours= 510 Hours

Min Notional Hours = 510 Hours

Maximum Duration of the Course Compulsory Notional Hours
Theory= 210 Hours
Practical= 240 Hours
Employability Skills= 60 Hours
Total Compulsory Notional Hours= 510 Hours

Notional Hours for Optional Module

Theory=30 Hours
Practical= 60 Hours
Total Notional Hours for Optional Module= 90 Hours

Max Notional Hours with 1 Option= 600 Hours

Apprenticeship Duration=6 months

Note:
Apprenticeship is exempted for B. Pharma Students

3 | Chemist Store (Pharma, Biological Products and Medical Devices)

 Program Overview
This section summarizes the end objectives of the program along with its duration.

Training Outcomes
At the end of the program, the learner should have acquired the listed knowledge and skills.

 Discuss performance of Store Supervisor in compliance with Good Manufacturing

Practices (GMP) and other environmental regulatory guidelines.
 Explain the concept of material inspection and waste disposal .
 Demonstrate good documentation practice (GDP) and data integrity while reporting
and documentation as per standard operating procedures (SOP).
 Demonstarte how to coordinate with supervisor, colleagues and respond to audit
queries during GMP/ regulatory audits.
 Demonstrate sensitivity towards genders, cultures and specially-abled persons.
 Demonstrate receiving and dispatching activities.

4 | Chemist Store (Pharma, Biological Products and Medical Devices)

Notional Hours Distribution:
NOS/ Module Details Total Level Credit
Duration
Hours

Compulsory Bridge Module 60:00 Level-4 2.00

Introduction to Life Sciences industry and
the job role & managing environmental
sustainability
Compulsory Module 90:00 Level-4 3.00
LFS/N0601 v3.0:Supervise warehouse
operations
Compulsory Module 60:00 Level-4 2.00
LFS/N0602 v3.0: Carry out reporting and
documentation for appropriate storage of
material/ products
Compulsory Module 60:00 Level-4 2.00
LFS/N0656 v3.0: Supervise waste disposal
as per environment sustainable practices
Compulsory Module 60:00 Level-4 2.00
LFS/N0118 v2.0: Coordinate with
supervisor, teammates, and cross-functional
teams
Compulsory Module 60:00 Level-4 2.00
LFS/N0113 v2.0: Ensure a hygienic and
clean work area to avoid contamination
Compulsory Module 60:00 Level-4 2.00
LFS/N0101 v3.0: Follow Environment,
health and safety guidelines in GMP/GLP
controlled areas and laboratory
DGT/VSQ/N0102: Employability Skills (60 60:00 2.00
Hours)
Option 1 : Automated warehouse 90:00 Level-4 3.00
operations
LFS/N0667 v2.0: Supervise automated
warehouse operations
Total Duration of Maximum Notional Hours 600:00 20.00
Mandatory Apprenticeship 6 Months

5 | Chemist Store (Pharma, Biological Products and Medical Devices)

 Details of Modules (Compulsory & Option) and Apprenticeship

Compulsory Modules
The table lists the modules and their duration corresponding to the Compulsory NOS of the
QP.

NOS and Module Details Theory Practical On-the-Job On-the-Job Total

Duration Duration Training Training Duratio
Duration Duration n
(Mandator (Recomme
y) nded)
Bridge Module 30:00 30:00 00:00 00:00 60:00

Module 1:Introduction to 15:00 00:00 00:00 00:00 15:00

Life Sciences industry and
the job role
Module 2:Managing 15:00 30:00 00:00 00:00 45:00
environmental
sustainability
LFS/N0601:Supervise 30:00 60:00 00:00 00:00 90:00
warehouse operations
NOS Version No. 3.0
NSQF Level-4
Module 3: Warehouse 15:00 30:00 00:00 00:00 45:00
operations
Module 4: Inspection of 15:00 30:00 00:00 00:00 45:00
goods
LFS/N0602: Carry out 30:00 30:00 00:00 00:00 60:00
reporting and
documentation for
appropriate storage of
material/ products
NOS Version No. 3.0
NSQF Level-4
Module 5: Reporting and 30:00 30:00 00:00 00:00 60:00
documentation for storage
of materials
LFS/N0656: Supervise 30:00 30:00 00:00 00:00 60:00
waste disposal as per
environment sustainable
practices
NOS Version No. 3.0

6 | Chemist Store (Pharma, Biological Products and Medical Devices)

 NSQF Level-4
Module 6: Disposal of 30:00 30:00 00:00 00:00 60:00
waste material
LFS/N0118: Coordinate 30:00 30:00 00:00 00:00 60:00
with supervisor,
teammates, and cross-
functional teams
NOS Version No. 2.0
NSQF Level-4
Module 7: Coordinate with 15:00 15:00 00:00 00:00 30:00
manager, colleagues and
auditors
Module 8: Sensitivity 15:00 15:00 00:00 00:00 30:00
towards all genders and
people with disability
LFS/N0113: Ensure a 30:00 30:00 00:00 00:00 60:00
hygienic and clean work
area to avoid
contamination
NOS Version No. 2.0
NSQF Level-4
Module 9: Cleaning and 30:00 30:00 00:00 00:00 60:00
sanitization at workplace
LFS/N0101 : Follow 30:00 30:00 00:00 00:00 60:00
Environment, health and
safety guidelines in
GMP/GLP controlled areas
and laboratory
NOS Version No. 3.0
NSQF Level-4
Module 10: Comply EHS 30:00 30:00 00:00 00:00 60:00
rules in GMP/GLP
controlled area
DGT/VSQ/N0102 : Employability Skills (60 Hours)
NOS Version No. 1
Module 11: Employability Skills
Introduction to 01:30 00:00 00:00 00:00 01:30
Employability Skills
Constitutional values – 01:30 00:00 00:00 00:00 01:30
Citizenship

7 | Chemist Store (Pharma, Biological Products and Medical Devices)

 Becoming a Professional in 02:30 00:00 00:00 00:00 02:30
the 21st Century
Basic English Skills 10:00 00:00 00:00 00:00 10:00
Career Development & 02:00 00:00 00:00 00:00 02:00
Goal Setting
Communication Skills 05:00 00:00 00:00 00:00 05:00
Diversity and Inclusion 02:30 00:00 00:00 00:00 02:30
Financial and Legal Literacy 05:00 00:00 00:00 00:00 05:00
Essential Digital Skills 10:00 00:00 00:00 00:00 10:00
Entrepreneurship 07:00 00:00 00:00 00:00 07:00
Customer Service 05:00 00:00 00:00 00:00 05:00
Getting ready for 08:00 00:00 00:00 00:00 08:00
apprenticeship & Jobs
Apprenticeship Training 00:00 00:00 990:00 00:00 990:00
Total Duration 270:00 240:00 990:00 00:00 1500:00

*detailed Curriculum of employability skills is enclosed as Annexure-2

8 | Chemist Store (Pharma, Biological Products and Medical Devices)

Optional Modules
The table lists the modules and their duration corresponding to the Optional NOSs of the
QP.

Option 1: Automated warehouse operations

NOS and Module Details Theory Practical On-the-Job On-the-Job Total

Duration Duration Training Training Duratio
Duration Duration n
(Mandator (Recommen
y) ded)
LFS/N0667: Supervise 30:00 60:00 00:00 00:00 90:00
automated warehouse
operations
NOS Version No. 2.0
NSQF Level-4
Module 12: Preparation 15:00 30:00 00:00 00:00 45:00
for operations
Module 13: 15:00 30:00 00:00 00:00 45:00
Documentation and
quality control
Total 30:00 60:00 00:00 00:00 90:00

9 | Chemist Store (Pharma, Biological Products and Medical Devices)

 Module Details

Module 1: Introduction to Life Sciences industry and the job role

Bridge Module

Terminal Outcomes:

 Explain the overview of the Life Sciences industry in regulation applicable to store
chemist/supervisor.
 Discuss the importance of a skilled store chemist/supervisor.

Duration: 15:00 Duration: 00:00

Theory – Key Learning Outcomes Practical – Key Learning Outcomes
 Discuss the Life Sciences industry in
Indian and global context.
 Discuss the regulatory authorities,
regulations, legislation, and good
practices (GxP) relevant to the Chemist-
store in a life sciences manufacturing
facility.
 Explain the basic skills required to
perform the job of Chemist-store.
 Explain the importance of a Chemist-
store.
 Explain the impact of non-compliance on
the quality of the product and the
environment.

Classroom Aids:
Whiteboard, Marker Pen, Computer or Laptop attached to LCD projector/ screen,
Scanner, Computer speakers, Pencil
Tools, Equipment and Other Requirements
N/A

10 | Chemist Store (Pharma, Biological Products and Medical Devices)

Module 2: Managing environmental sustainability
Bridge Module

Terminal Outcomes:

 Discuss the importance of environmental sustainability.

 Demonstrate the adoption of environmental sustainability methods at work for
minimizing pollution, water wastage, and maximizing energy conservation.

Duration: 15:00 Duration: 30:00

Theory – Key Learning Outcomes Practical – Key Learning Outcomes

 Explain the concept and importance of  Create a checklist of energy conservation

energy conservation practices during and post-work.
 Describe the possible actions to optimize  Segregate waste into recyclable, non-
energy consumption and minimize recyclable, and hazardous.
energy wastage.  Demonstrate the sustainable waste
 Explain the concept of environmental disposal process.
pollution and its impact on the health of
self, community, and planet.
 Describe the possible actions to be taken
to minimize environmental pollution at
work
 Explain various guidelines to be followed
for hazardous waste management and
disposal of waste.
Classroom Aids:

Whiteboard, Marker Pen, Computer or Laptop attached to LCD Projector/ Screen, Scanner,
Computer Speakers, Pencil

Tools, Equipment and Other Requirements

Color-coded waste bin bag, Color-coded waste container

11 | Chemist Store (Pharma, Biological Products and Medical Devices)

Module 3: Warehouse operations
Mapped to LFS/N0601, v3

Terminal Outcomes:

 Explain about various warehouse operations.

 Explain the guidelines related to material safety and handling

Duration: 15:00 Duration: 30:00

Theory – Key Learning Outcomes Practical – Key Learning Outcomes
 Describe the characteristics of the raw  Perform wall to wall inventory count and
material ,packaging materials and generate report.
Finished Goods  Perform visual inspection of inbound and
 Explain good storage practices outbound goods.
 Explain the different inventory models  Demonstrate the methods of recording
and type of warehouses. results of action taken in a standard
 Discuss the instructions regarding format.
shipments, MHEs, equipment and  Demonstrate how to update stock
work-place. control systems .
 Explain the special characteristics and  Demonstrate how to check the material
handling requirements of shipments. specification for proper storage
 Discuss the guidelines related to conditions
material safety.
 Explain requirements for maintaining
security and safety during delivery and
storage of goods.
 Explain the coding system of finished
goods.
 Discuss the levels of hygiene required
by storage area.
Classroom Aids:
Whiteboard, Marker Pen, Computer or Laptop attached to LCD projector/ screen,
Scanner, Computer speakers, Pencil
Tools, Equipment and Other Requirements
SOP, Role plays,Equipments used for material movement,Flip charts

12 | Chemist Store (Pharma, Biological Products and Medical Devices)

Module 4: Inspection of goods
Mapped to LFS/N0601, v3

Terminal Outcomes:

 Discuss the process and procedures for inspection in storage area.

Duration: 15:00 Duration: 30:00

Theory – Key Learning Outcomes Practical – Key Learning Outcomes

 Discuss the concept of Just in Time (JIT).  Identify reason for variation between
 Discuss the correct methods of storage physical and system inventory.
of goods according to GMP.  Demonstrate the methods of recording
 Explain the the role and purpose of an results of action taken in a standard
effective stock taking program. format.
 Explain the principles/techniques of  Demonstrate how to check he material
good inspection practices and visual specification for proper storage
standards applied in the workplace. conditions.
 Discuss the standard method of  Perform stock checks to ensure raw
drawing samples and preparing them material availability.
for testing.  Demonstrate how to calculate taxable
 Discuss the Standard Operating values.
Procedures (SOP) related to segregation  Prepare claims reports for damaged
of damaged goods. goods.
 Describe the Enterprise Resource  Demonstrate how to check and facilitate
Planning (ERP) system. disposal of contaminated or leakage
 Explain the procedure for dealing with items.
loss or damage of goods.  Perform total range of checks on the
 Explain the principles of different packaging material.
material handling equipment and their
uses.
Classroom Aids:

Whiteboard, Marker Pen, Computer or Laptop attached to LCD projector/ screen,

Computer speakers, Pencil

Tools, Equipment and Other Requirements

SOP, Role plays,Flip charts

13 | Chemist Store (Pharma, Biological Products and Medical Devices)

Module 5: Reporting and documentation for storage of materials
Mapped to LFS/N0602, v3

Terminal Outcomes:

 Explain the methods of reporting and documentation for the storage operations.
 Discuss how to perform documentation for storage operations in compliance with
Good Documentation Practices(GDP) and other regulatory guidelines.

Duration: 30:00 Duration: 30:00

Theory – Key Learning Outcomes Practical – Key Learning Outcomes
 Describe the types of documentation in  Demonstrate how to perform reporting
an organization and the importance of and documentation as per GDP and
maintaining the same. other regulatory guidelines.
 Explain the method of reporting and  prepare inspection reports as per
documentation as per Good inspection activity performed.
Documentation Practices(GDP) and  Demonstrate the use of computer/ and
other regulatory guidelines. software like MS Office, or it's alternative
 Describe the Attributable, Legible, for reporting.
Contemporaneous, Original, and
Accurate Plus (ALCOA +) principle and its
importance.
 Discuss how to use lab information
management system.
 Explain statistical concepts and
application of statistical tools.
 Discuss guidelines for Electronic Records
& Electronic Signatures, Audit Trails,
Date and Time Stamps, Data Integrity in
the life sciences sector.

Classroom Aids:
Whiteboard, Marker Pen, Computer or Laptop attached to LCD projector, Scanner,
Computer speakers
Tools, Equipment and Other Requirements
N/A

14 | Chemist Store (Pharma, Biological Products and Medical Devices)

Module 6: Disposal of waste material
Mapped to LFS/N0656, v3

Terminal Outcomes:

 Supervise the waste disposal of materials.

Duration: 30:00 Duration: 30:00

Theory – Key Learning Outcomes Practical – Key Learning Outcomes

 Explain various guidelines to be followed  Demonstrate the correct methods of

for hazardous waste management and disposal of waste according to GMP.
disposal of waste  Demonstrate how to dispose the non-
 Explain WHO regulations and Good conforming packaging material as per
Manufacturing Practices (GMP) SOP.
guidelines for waste management  Perform waste disposal under
supervision in compliance with WHO
guidelines and ICH-cGMP rules.

Classroom Aids:

Whiteboard, Marker Pen, Computer or Laptop attached to LCD projector/ screen,

Computer speakers, Pencil

Tools, Equipment and Other Requirements

N/A

15 | Chemist Store (Pharma, Biological Products and Medical Devices)

Module 7: Coordinate with Manager, colleagues and auditors
Mapped to LFS/N0118, v2

Terminal Outcomes:

 Describe various scenarios at work that demand coordination and collaboration with the
manager, team, and cross-functional stakeholders.
 Demonstrate the effective coordination and collaboration with manager, cross-functional
teams.

Duration: 15:00 Duration: 15:00

Theory – Key Learning Outcomes Practical – Key Learning Outcomes
 Explain the reporting structure of the  Demonstrate how to effectively
organization. communicate and collaborate with
 List the functional and cross-functional various stakeholders (e.g. manager,
stakeholders for Machine operator. groups etc.) in a simulated environment
 Explain efficient and clear communication for multiple scenarios.
methods for reporting incidents/  Demonstrate how to resolve conflict in
deviations. multiple scenarios.
 Explain the techniques for gaining  Demonstrate how to communicate with
emotional stability. auditors and regulatory inspectors
 Discuss various ways for conflict during inspections/audits.
resolution.
 Explain the best strategies of
collaborating with others.
 Describe the problem-solving techniques
for routine work-related issues.
 Explain the type of audits in the life
sciences sector for the quality operations.

Classroom Aids:
Whiteboard, Marker Pen, Computer or Laptop attached to LCD projector, Scanner,
Computer speaker, Pencil

Tools, Equipment and Other Requirements

N/A

16 | Chemist Store (Pharma, Biological Products and Medical Devices)

Module 8: Sensitivity towards all genders and people with disability
Mapped to LFS/N0118, v2

Terminal Outcomes:

 Describe the prevention of sexual harassment (POSH) rules at the workplace.

 Demonstrate how to respect all genders and cultures at the workplace.
 Explain the importance of sensitivity towards people with disability.
Duration: 15:00 Duration: 15:00
Theory – Key Learning Outcomes Practical – Key Learning Outcomes
 Discuss the rules laid by the Sexual  Demonstrate appropriate verbal and
Harassment of Women at Workplace nonverbal communication that is
(Prevention, Prohibition, and Redressal) respectful of gender, religion, disability,
Act and the provided penalties for etc.
violation.  Prepare a list of gender neutral
 Explain the importance of gender communication terms.
sensitive behaviour.
 Explain the procedure to report
inappropriate behaviour e.g. sexual
harassment.
 Describe the importance of an equal
opportunity work culture.
 Discuss the importance of respecting
other’s cultures, religion, and caste.
 Explain the need for sensitivity towards
people with disabilities.
 Explain the correct ways of
communication and collaboration with
people with disabilities in compliance
with the legal framework.
 Identify stereotypes and prejudices
associated with people with disabilities
and the negative consequences of
prejudice and stereotypes.
Classroom Aids:
Whiteboard, Marker Pen, Computer or Laptop attached to LCD projector, Scanner,
Computer speakers, flip charts
Tools, Equipment and Other Requirements
N/A

17 | Chemist Store (Pharma, Biological Products and Medical Devices)

Module 9: Cleaning and Sanitization at workplace
Mapped to LFS/N0113, v2

Terminal Outcomes:

 Demonstrate how to perform cleaning and sanitation activities before, during and
after work.

Duration: 30:00 Duration: 30:00

Theory – Key Learning Outcomes Practical – Key Learning Outcomes
 Describe levels of hygiene standards  Prepare a check list of the hygiene
required in the production area and the standards required in the production
importance of maintaining the same. area.
 Explain the methods, materials, and checks  Demonstrate how to clean and check
required for cleaning a variety of surfaces surfaces, equipment, and instruments
and equipment. by applying appropriate methods and
 Explain the list of various equipment, materials.
machines, instruments, different materials,  Perform cleaning and sanitation of
and chemicals used in cleaning and production area using various
sanitation of production area. equipment and chemicals.
 Explain the essential Good Manufacturing  Demonstrate how to handle different
Practices (GMP) and WHO guidelines and types of hazards by applying critical
rules for cleaning, sanitation, and hygiene thinking skills.
activity.
 Explain waste disposal guidelines as per
WHO and GLP/GMP and relevant
organizational Standard Operating
Procedures (SOPs).
 Discuss the concept of cleaning validation
and its importance.

Classroom Aids:
Whiteboard, Marker Pen, Computer or Laptop attached to LCD projector, Scanner,
Computer speaker, Pencil

Tools, Equipment and Other Requirements

Cleaning agents (soap/alconox etc.), Glassware for cleaning ,Half Face Mask, Gloves(Nitrile,
{Heat, acid, chemical} resistant, washing etc..), and PPE

18 | Chemist Store (Pharma, Biological Products and Medical Devices)

Module 10: Comply EHS rules in GMP/GLP controlled area
Mapped to LFS/N0101, v3

Terminal Outcomes:

 Explain the health and hygiene protocols to be followed in production and GMP
controlled area.
 Describe safety, security and emergency procedures at the production and GMP
controlled area.

Duration: 30:00 Duration: 30:00

Theory – Key Learning Outcomes Practical – Key Learning Outcomes
 Explain relevant legislative requirements  Demonstrate how and when to report
and company’s procedures for the hazards at the workplace.
environment, health and safety including an  Demonstrate emergency procedures
individual’s role and responsibilities. to be followed in different
 Discuss workplace hazards in the emergencies.
manufacturing facility in the life sciences  Demonstrate how to evacuate
sector including how and when to report employees, contract staff and visitors
hazards. as per procedures in case of
 Explain all the emergency procedures for emergency.
different emergencies.  Demonstrate how to use different
 Explain the evacuation procedures for types of safety gears by following the
employees, contract staff and visitors. procedures to use them.
 Discuss health, safety and accident
reporting procedures.
 Explain the importance of material
segregation and 5S system.
 Discuss the type of safety gears and
procedure to use them.

Classroom Aids:
Whiteboard, Marker Pen, Computer or Laptop attached to LCD Projector/ Screen,
Scanner, Computer Speakers, Pencil
Tools, Equipment and Other Requirements
Printouts of WHO guidelines, Flashcards of signages, oding, and instructions, CO2 type Fire
Extinguisher, ABC Type Fire Extinguisher, Personal Protective Equipments and Gowning
material

19 | Chemist Store (Pharma, Biological Products and Medical Devices)

Module 11: Employability Skills (60 Hours)
Mapped to DGT/VSQ/N0102 - v1.0

Mandatory Duration: 60:00

Module Name: Employability Skills

This is compulsory module introduced by Directorate General of Training (DGT). For

further details regarding module please find at below link.

https://www.nqr.gov.in/national-skills-qualification-framework

20 | Chemist Store (Pharma, Biological Products and Medical Devices)

Module 12: Preparation for operations
Mapped to LFS/N0667, v2

Terminal Outcomes:

 Discuss the operations to be performed to set up computer.

 Demonstrate how to print all requisite lists, labels and forms.

Duration: 15:00 Duration: 30:00

Theory – Key Learning Outcomes Practical – Key Learning Outcomes
 Discuss the safety regulations  Demonstrate how to power up
and procedures. computer terminal and log.
 Explain the security procedures to  Demonstrate how to supervise and check
entries on the Warehouse Management
be followed.
System(WMS).
 Explain the stock recording
 Demonstrate how to complete
procedures.
software updates.
 Discuss the rules and regulations at  Perform verification of clients details on
pick- up site. the information system.
 Discuss the importance of ERP  Demonstrate how to calculate taxable
software and its applications. values.
 Prepare print list based on orders, labels for
inbound/outbound goods and details
available for incoming goods.
Classroom Aids:
Whiteboard, Marker Pen, Computer or Laptop attached to LCD projector, Scanner,
Computer
speaker, Pencil
Tools, Equipment and Other Requirements
N/A

21 | Chemist Store (Pharma, Biological Products and Medical Devices)

Module 13: Documentation and quality control
Mapped to LFS/N0667, v2

Terminal Outcomes:

 Discuss the procedures to complete requisite documentation.

 Discuss the safety, security and administrative procedures.

Duration: 15:00 Duration: 30:00

Theory – Key Learning Outcomes Practical – Key Learning Outcomes
 Discuss the risk and impact of not  Demonstrate how to generate print- outs for
following defined work, safety and all transports and maintain logs and files.
security procedures.  Demonstrate how to transcribe information
from customers' bill of lading into cargo
 Explain stock recording procedures.
management system.
 Explain the chain of command for
 Perform day-to-day
reporting problems and status of administrative documentation.
delivery.  Monitor the quality, quantity, cost and
 Discuss the rules and regulations at efficiency
pick-up site. of the movement and storage of goods.
 Discuss the importance of ERP  Demonstrate how to generate daily, monthly
and annual reports and MIS trackers based on
software and its applications.
performance.
 Discuss the importance of wearing
 Perform a physical check to reconcile data
safety gear on any visits to the with documentation/system.
shop
floor.
Classroom Aids:
Whiteboard, Marker Pen, Computer or Laptop attached to LCD projector, Scanner,
Computer
speaker, Pencil
Tools, Equipment and Other Requirements
N/A

22 | Chemist Store (Pharma, Biological Products and Medical Devices)

Module 14: Apprenticeship Training
Mapped to Chemist Store (Pharma, Biological Products and Medical Devices)

Mandatory Duration: 990:00 (6 Months) Recommended Duration: 00:00

Module Name: On the Job Training
Location: On-Site
Terminal Outcomes

 Allocate resources and streamline operations at warehouse.

 Supervise receiving and dispatching activities.
 Carry out reporting and documentation for appropriate storage of material/products.
 Ensure cleanliness in the work area.
 Maintain a healthy, safe and secure working environment in the life sciences facility
environment.

23 | Chemist Store (Pharma, Biological Products and Medical Devices)

 Annexure 1

Trainer Requirements

Trainer Prerequisites
Minimum Specialization Relevant Industry Training Experience Remarks
Educational Experience
Qualification Years Specialization Years Specialization

B. Sc. / B. 6 Pharma 1 NA
Graduate in Pharma/D.Pharma Store/
Sciences Warehouse
operations

M Sc. / M. Pharma 4 Pharma 1 NA

Postgraduate Store/
in Sciences Warehouse
operations

Trainer Certification
Domain Certification Platform Certification
Certified for Job Role: “Chemist-Store Recommended that the Trainer is certified for the
(Pharma, Biological Products and Medical Job Role: “Trainer (VET and Skills)”, mapped to the
Devices)” mapped to QP: “LFS/Q0601, v3.0” Qualification Pack: “MEP/2601, v2.0” with
with minimum accepted score of 80%. minimum score of 80%.

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Assessor Requirements

Assessor Prerequisites
Minimum Specialization Relevant Industry Training/Assessmen Remark
Educational Experience t Experience s
Qualificatio Year Specializatio Year Specializatio
n s n s n

Graduate in B. Sc. / B. 5 Pharma 2 NA

Sciences Pharma/D.Pharm Store/
a Warehouse
operations

Postgraduat M Sc. / M. 3 Pharma 2 NA

e in Sciences Pharma Store/
Warehouse
operations

Assessor Certification
Domain Certification Platform Certification
Certified for Job Role: “Chemist-Store Recommended that the Assessor is certified for
(Pharma, Biological Products and Medical the Job Role: “Assessor (VET and Skills)”,
Devices)” mapped to QP: “LFS/Q0601, v3.0” mapped to the Qualification Pack:
with minimum accepted score of 80%. “MEP/Q2701, v2.0” with minimum score of
80%.

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Assessment Strategy
This section includes the processes involved in identifying, gathering, and interpreting
information to evaluate the learner on the required competencies of the program.

The assessment for the Training will be conducted toward the end of the training duration.

Assessment Process:

For Execution of the assessment for training, LSSSDC will be engaging more than one
assessment agency/ body.

1.1 Criteria of selection of assessment body/agency:

The assessment body/agency is selected based on

 Prior experience and understanding of Life Sciences or similar sector.
 Experience in conducting assessments for similar job roles.
 Manpower and Technical capabilities.
 Geographical reach
 Existing Network in the Life Sciences Sector
 Agencies internal policies to maintain standards, quality & professional Integrity
 Agencies policy in assessor management

1.2 Assessment tool for Training:

For the Training assessment, the assessment instrument development is done by the selected
assessment body with close monitoring and support of LSSSDC at every stage.

1.2.1 Digital Written test for knowledge assessment:

Scope – Is used to test the knowledge component of the QP.

Tools –computer or tab based online or offline.

Method – objective type questions, match the columns, fill in the blanks, tick the odd man
out, choose the correct option, choose the best answer, True or false, Identify the object, tool
or machinery, arrange in proper sequence, case study, scenario-based responses.

Analysis – Question paper is divided into sections. Each Section intends to assess a particular
knowledge field of the trainee. Thus, section-wise calculation of marks gives a clear idea of
the areas of improvement or expertise of the trainee. While a consolidated mark gives the
overall rating of the trainee.

2.2.2 Digital Written test for skill assessment:

26 | Chemist Store (Pharma, Biological Products and Medical Devices)

Scope – Is used to test primarily the Skill component of the QP. Trainee’s expertise in handling
and managing the situation is tested.

Tools – computer or tab based online or offline questions

Method – A situation is narrated or created in the question posed to the trainee and he is
asked objective type questions to select the correct reaction to the situation. The selected
situations are based on real situations.

Analysis – Question paper is divided into sections. Each Section intends to assess a particular
skill field of the trainee. Thus, section-wise calculation of marks gives a clear idea of the areas
of improvement or expertise of the trainee. While a consolidated mark gives the overall rating
of the trainee.

2.3 Steps for assessment development:

 The selection of assessment tool(s) is done as per the assessment criteria prescribed
in Qualification Pack.
 For Chemist Store (Pharma, Biological Products and Medical Devices) assessment a
blueprint of the question paper is part of the assessment tool for training.
 Development of layout of Question paper is such that the entire PCs (Performance
Criteria) of that QP are covered.
 Score per question maps with the weightage given to that PC, in the assessment
criteria, and the level of difficulty of the question.
 An expert from industry is selected who is called “Subject Matter Expert” (SME). This
SME must have over 13-15 years of experience in the industry in Supply Chain
Management.
 SME is screened and approved by LSSSDC. He is oriented by both LSSSDC and
Assessment agency on – creating question Bank, level of questions, end the desired
outcome of the assessment.

2.4 Execution of Training Assessment:

 Once LSSSDC receives the OJT assessment results, the assessment date for training is
decided with common agreement of Industry and LSSSDC, and turn is directed to an
assessment body/agency.
 Assessment agency ensures the availability of required infrastructure, tools for the
assessment.
 The assessment is executed in two possible ways depending on the choice of the
industry:

2.4.1 Tab based assessment using physical proctoring

2.4.2 Smartphone-based assessment using e-proctoring
27 | Chemist Store (Pharma, Biological Products and Medical Devices)
2.4.1 Tab-based assessment using physical proctoring
 A representative from the Assessment agency is present on the day of assessment to
executing the assessment at the venue in case of physical proctoring.
 The assessment agency representative carries an identity card and letter from the
council authorizing to conduct the assessment.
 Assessment agency representative ensures the authenticity of Trainee’s identity by
verifying the documents (any document issued by GOI, such as Ration card, Aadhaar
Card, Driving Licence, Passport, Election card, etc)
 The assessment agency representative maintains the records of attendance, verified
documents, and tablet instruments used in the assessment.
 Assessment agency representative collects evidence of the assessment in the best
possible way (videos, pictures, voice recordings, etc)
 Assessment agency representative transfers the assessment scores from tab to
assessment agency server, using a secure, encrypted web-based program.
 The assessment agency after processing the results and putting them in standard
format hands over to LSSSDC within 7 days of assessment.

2.4.2 Smartphone-based assessment using e-proctoring

 All trainees due for assessments are registered on an assessment tool application
using their unique mobile number and e-mail ID along with a Govt. ID issued proof.
 An assessment link is sent to the mail ID of each trainee with a defined expiry date of
the link.
 Trainee at any location can click on the link using his/her smartphone or a web
camera-enabled computer system
 Using the unique credentials and Govt ID number, the trainee logs in for the start of
assessment and completes the assessment.
 The authenticity of Trainee’s identity is done by assessment application by verifying
the documents (any document issued by GOI, such as Ration card, Aadhaar Card,
Driving Licence, Passport, election card, etc.) and a live photo capture
 A live video of the candidate during the assessment is captured to collect the evidence
of the assessment
 Once the assessment is complete, the assessment application automatically
assessment scores to the assessment agency server, using a secure, encrypted web-
based program.
 The assessment agency after processing the results and putting them in standard
format hands over to LSSSDC within 7 days of assessment.

28 | Chemist Store (Pharma, Biological Products and Medical Devices)

 Annexure -2

Model Curriculum for Employability Skills

1. Employability Skills (60 hours)
Learning outcomes, assessment criteria, syllabus and Tool List of Employability Skills which is
common for all sectors, provided separately in

https://www.nqr.gov.in/national-skills-qualification-framework

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References

Glossary

Term Description

Declarative Declarative knowledge refers to facts, concepts, and principles that

Knowledge need to be known and/or understood to accomplish a task or to solve
a problem.
Key Learning The key learning outcome is the statement of what a learner needs to
Outcome know, understand, and be able to do to achieve the terminal
outcomes. A set of key learning outcomes will make up the training
outcomes. Training outcome is specified in terms of knowledge,
understanding (theory), and skills (practical application).
OJT (M) On-the-job training (Mandatory); trainees are mandated to complete
specified hours of training on-site

OJT (R) On-the-job training (Recommended); trainees are recommended the

specified hours of training on-site
Procedural Procedural knowledge addresses how to do something, or how to
Knowledge perform a task. It is the ability to work or produce a tangible work
output by applying cognitive, affective, or psychomotor skills.
Training Training outcome is a statement of what a learner will know,
Outcome understand, and be able to do upon the completion of the training.
Terminal The terminal outcome is a statement of what a learner will know,
Outcome understand, and be able to do upon the completion of a module. A
set of terminal outcomes helps to achieve the training outcome.

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Acronyms and Abbreviations

Term Description

QP Qualification Pack
NSQF National Skills Qualification Framework
NSQC National Skills Qualification Committee
NOS National Occupational Standards
GLP Good Laboratory Practices
GMP Good Manufacturing Practices
WHO World Health Organization
SOP Standard Operating Procedure
MSDS Material Safety Datasheets
GDP Good Documentation Practices
EHS Environment Health Safety
PPE Personal Protective Equipment

31 | Chemist Store (Pharma, Biological Products and Medical Devices)