PHARMACEUTICAL INDUSTRIAL

TRAINING
AS PART OF PRACTICE SCHOOL

At
SUN PHARMACEUTICALS MEDICARE LIMITED

BY,
Guided by,
Nikunj Unadkat
Ms. Vandana Parmar
Roll no:-25
Exam no:-701028
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 Table of contents
Company profile
Departments
• Warehouse
• Production
• Quality control
• Quality Assurance
• Engineering
• EHS
• IT
Certificate
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 Company profile
• Sun Pharma is the largest Pharma Company in
India and 4th largest in the world.
• The company offers formulations in various
therapeutic areas, such as cardiology,
psychiatry, neurology, gastroenterology and
diabetology. It also provides APIs such as
warfarin, carbamazepine, etodolac, and
clorazepate, as well as anti-cancers, steroids,
peptides, sex hormones, and controlled
substances.
• Company’s broad portfolio of more than 2000
high quality molecules covers multiple dosage
forms, including tablets, capsules, injectables,
inhalers, ointments, creams, and liquids.
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 Warehouse
• Warehouse Management System (WMS):

• A warehouse management system (WMS) consists of software and processes that allow
organizations to control and administer warehouse operations from the time goods or materials
enter a warehouse until they move out.

• Warehouses sit at the centre of manufacturing and supply chain operations because they hold all of
the material used or produced in those processes, from raw materials to finished goods.

• A WMS handles many functions that enable these movements, including inventory tracking, picking,
receiving and put away, it also provides visibility into an organization's inventory at any time and
location, whether in a facility or in transit.
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• There are 3 stations in WMS:

✓ Approved Picking Station (GREEN)

✓ Partial Picking Station (YELLOW)

✓ Rejected Picking Station (RED)

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 Production Department
Lyophilization
• Freeze drying is a method of extracting the water from biological samples, foods
and other products so that foods or products remain stable and are easier to store
at room temperature. Biological materials should be dried to stabilize them for
storage, preservation and shipping.
• In many cases this drying can cause damage and some loss of cellular or protein
activity. Lyophilization significantly reduces damage to biological samples.
• Principle of Lyophilization:
• Lyophilization is based on a simple principle of physics called “SUBLIMATION”.
Sublimation is the process of transition of a substance from solid to the vapor
state without passing through an intermediate liquid phase.
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Process of lyophilization
Freezing of the After freeze-
product to dried, the
Drawing off the
convert the water product be
in the product to water vapor.
removed from
ice form. machine.

Sublimation of Once the ice has

ice directly into been sublimated,
water vapor the products are
under vacuum. freeze-dried.
 Advantages:
Disadvantages:
• Speed and completeness of
rehydration • High capital cost of
equipment (about three times
• Possibility of accurate, clean more than other methods)
dosing into final product
containers • High energy costs (2-3 times
more than other methods)
• Minimum damage and loss of
activity in delicate heat-liable • Long process time (typically
materials 24-hour drying cycle)

• Porous, friable structure

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 Quality Control Department
• Quality Control (QC) is a process through which a business seeks to ensure that
product quality is maintained or improved. This is done by training personnel,
creating benchmarks for product quality, and testing products to check for
statistically significant variations.
• All the materials which are to be tested should be given to QC along with the test
requisition slip by the production unit.
• This slip includes the stage of production, name of the drug, quantity given for
test, date, and signature of the production head
• After conducting the test, QC will send the Certificate of Analysis (COA), to the
concerned department which has information about all the tests which were done
and their result along with the standard value

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 QC Micro
• There 5 types of tests performed in QC (Micro Department):
1. Sterility Testing: It is free from microbes.
2. Bacteria: Endotoxin test is performed to check endotoxin level
3. Preservative Efficacy Test: To check preservative content, if it is effective or not
4. Microbial Limit Test: To check how many viable microorganisms are present in
nonsterile pharmaceuticals
5. Water Testing: It is done for routine testing of water

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 Quality Assurance Department
• Quality assurance (QA) is a way of preventing mistakes and defects in
manufactured products and avoiding problems when delivering products or
services to customers; which ISO 9000 defines as "part of quality management
focused on providing confidence that quality requirements will be fulfilled".
• Quality Management System: It ensures every time a process is performed. The
same information, methods, skills & controls are used & applied in consistent
manner.
• There are 5 systems in QMS:

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1. Change Control: Used to ensure that changes to a product or system
are introduced in a controlled & co-ordinated manner.

2. Deviation: It is an unexpected event that occur during the on-going

operation or activity. The given standards should be followed

3. Corrective Action / Preventive Action (CAPA): To collect information,

analyse, identify & investigate product & quality problems to take appropriate
& corrective, preventive action to correct the recurrence.

4. Internal Audit (Self-Instructor): Offers risk management & evaluate the

effectiveness of a company, internal controls, corporate & accounting process.
It checks standard regulations & rules.

5. Compliance: It includes review of document such as batch record, charts,

logos, & meeting regulatory requirements.
 Engineering Department:

• AHU (Air Handling Unit) / Service Loop: An air handler, or

air handling unit (often abbreviated to AHU), is a device
used to regulate and circulate air as part of a heating,
ventilating, and air-conditioning (HVAC) system.
• An air handler is usually a large metal box containing a
blower, heating or cooling elements, filter racks or
chambers, sound attenuators, and dampers.
• Air handlers usually connect to a ductwork ventilation
system that distributes the conditioned air through the
building and returns it to the AHU.

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 Environment Health Safety Department (EHS):
• EHS stands for Environment, Health & Safety. Environment is the natural world around you
and in the context of compliance, the “E” of EHS indicates the regulations that are designed to
protect the environment. The “S” refers to regulations intended to protect the safety of
employees on worksites and the “H” is the health of employees.
• Fire Hydrant System: It is a safety measure or emergency equipment required in buildings that
comprises a series of components that when assembled together provide a source of water to
assist fire.
• Effluent Treatment Plant (ETP):
• The waste released out of pharmaceutical industries and drug manufacturing units contain
various ingredients, solvents and other substances that are harmful to humans and animals.
• Technologies such as aerobic / anaerobic treatment, membrane filtration and reverse osmosis
work efficiently for different streams of this industry that reduce Chemical Oxygen Demand
(COD), Biological Oxygen Demand (BOD)
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 Information Technology Department:

• SAP (Systems, Applications, and Products in Data Processing) is a leading

enterprise resource planning (ERP) software that helps organizations manage their
business operations efficiently.
• Key features of SAP software include:

1.Supply Chain 4. Sales and

Management Distribution
7. Financial
2. Regulatory 5. Production Management
Compliance Planning
8. Traceability
3. Research and 6. Quality
Development Management

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Certificate of training completion

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 Link to get final & weekly report:

https://drive.google.com/drive/folders/1u4hxgz21rOnjRrjvPJMPpl6PIO_L_fF9?usp=
drive_link

Thank You
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