A Glimpse into the Pharmaceutical Industry
1
By: Aseel Abuhamdah
Learning
Outcomes
Receive
statistical
overview of
pharma
industries
Learn
fundamental
ingredients in
tablets
Know the main
processes to
manufacture
tablets
Know the sub-
departments
present in a
Pharmaceutical
plant
2
Glossary
Good Manufacturing Practices (GMP): set of guidelines/practices that ensure medicines
produced are consistent to quality standards.
Active Pharmaceutical Ingredient (API): main ingredient in tablet that causes therapeutic
effect
Excipients: additional additives in tablet present for a function other than causing a
therapeutic effect
In –Process Control: mini Quality Control department that checks quality of tablets before
moving it to next step
3
Statistics
Top pharmaceutical companies in the world and revenues
4
Source: Wikipedia
Examples of Pharmaceutical
Companies in Jordan..
5
Tablet
Ingredients
Tablets have 6 main
ingredients; The API and other
five which are considered
excipients.
(Where did we mention API and
excipients before?)
API = main ingredient to cure a disease
Filler = fills the shape of a tablet mould
Lubricant = facilitates flow of particles from one
place to another
Glidant = prevents particles sticking to one another
or sticking to machines
Disintegrant = allows tablet to disintegrate into
smaller particles in the body
Binder = binds all aforementioned ingredients
together
6
Manufacturing
Processes
7
Main steps in manufacturing tablets
PackagingCoatingCompressionGranulationDispensing
8
The dispensing room is where required quantities of raw materials (mainly powders) are dispensed, using
scoops and drums for storage. The dispensing booth has special fans and filters to ensure there is no air
turbulence which causes contamination.
Scoop: to dispense powders/
raw materials
Dispensing booth that has balance
to measure weight of dispensed
material
Plastic Drum: dispensed materials
are placed here
Dispensing
9
Granulation
• Granulation is where raw materials are
mixed, dried and milled to change
powders to granules.
• The pictures represent machines in
granulating room.
• Granules have a rougher texture
compared to powders, this rougher
texture aids in the following step;
compression.
Granules vs Powders
10
Compression
• We input granules and receive tablets using
compression machines.
• Defected tablets are tablets with broken edges or
sticky ends.
• The In-Process Control (IPC) separates faulty tablets
from proper ones if the defect is considered major
Input
Granules
Receive
Tablets
Example of Tablet with broken edge
11
Coating
• A barrel rotates clockwise
and sprays coating layer to
tablet (red layer in image)
• A coating layer is sprayed to
improve taste, color or
protect tablets against UV
rays and physical
disruptions.
12
Packaging
• Tablets are nicely and attractively packaged.
The primary package is in direct contact
with tablets. Ex: blisters
• Secondary package is in direct contact with
blisters Ex: boxes
• Tertiary package is in direct contact with
boxes. Ex. Cartons
• The classification to primary, secondary or
tertiary is based on what the package
material contacts.
Primary Package
Tertiary Package
Secondary Package
13
Sub-departments in manufacturing plant
• Maintenance
14
• Compliance • Planning
Compliance team checks if processes and
technicians comply to GMP standards.
The team plans and sets
schedules of different
medicines to be produced in
upcoming months.
Maintenance team is present
24/7 for possibility of faulty issue
either in machines or elevators.
 Calibration
Ensure measuring devices read
correct measurements
15
Sub-departments in manufacturing plant
 In-Process Control
(IPC)
Ensure quality of products by
performing physical tests before going
to the next manufacturing step
Self-Assessment
• 1. What does API, GMP, and IPC stand for? (3 points)
• 2. What is the main difference between API and
Excipients? (1 point)
• 3. Mention three excipients and their functions. (3
points)
• 4. List the five stages in tablet manufacturing (3
points)
16
Sources
17
• Wikipedia- statistics
• http://www.worldstopexports.com/drugs-medicine-exports-country/
Thank You!
By: Aseel Abuhamdah
18

How Tablets are Manufactured?

  • 1.
    A Glimpse intothe Pharmaceutical Industry 1 By: Aseel Abuhamdah
  • 2.
    Learning Outcomes Receive statistical overview of pharma industries Learn fundamental ingredients in tablets Knowthe main processes to manufacture tablets Know the sub- departments present in a Pharmaceutical plant 2
  • 3.
    Glossary Good Manufacturing Practices(GMP): set of guidelines/practices that ensure medicines produced are consistent to quality standards. Active Pharmaceutical Ingredient (API): main ingredient in tablet that causes therapeutic effect Excipients: additional additives in tablet present for a function other than causing a therapeutic effect In –Process Control: mini Quality Control department that checks quality of tablets before moving it to next step 3
  • 4.
    Statistics Top pharmaceutical companiesin the world and revenues 4 Source: Wikipedia
  • 5.
  • 6.
    Tablet Ingredients Tablets have 6main ingredients; The API and other five which are considered excipients. (Where did we mention API and excipients before?) API = main ingredient to cure a disease Filler = fills the shape of a tablet mould Lubricant = facilitates flow of particles from one place to another Glidant = prevents particles sticking to one another or sticking to machines Disintegrant = allows tablet to disintegrate into smaller particles in the body Binder = binds all aforementioned ingredients together 6
  • 7.
  • 8.
    Main steps inmanufacturing tablets PackagingCoatingCompressionGranulationDispensing 8
  • 9.
    The dispensing roomis where required quantities of raw materials (mainly powders) are dispensed, using scoops and drums for storage. The dispensing booth has special fans and filters to ensure there is no air turbulence which causes contamination. Scoop: to dispense powders/ raw materials Dispensing booth that has balance to measure weight of dispensed material Plastic Drum: dispensed materials are placed here Dispensing 9
  • 10.
    Granulation • Granulation iswhere raw materials are mixed, dried and milled to change powders to granules. • The pictures represent machines in granulating room. • Granules have a rougher texture compared to powders, this rougher texture aids in the following step; compression. Granules vs Powders 10
  • 11.
    Compression • We inputgranules and receive tablets using compression machines. • Defected tablets are tablets with broken edges or sticky ends. • The In-Process Control (IPC) separates faulty tablets from proper ones if the defect is considered major Input Granules Receive Tablets Example of Tablet with broken edge 11
  • 12.
    Coating • A barrelrotates clockwise and sprays coating layer to tablet (red layer in image) • A coating layer is sprayed to improve taste, color or protect tablets against UV rays and physical disruptions. 12
  • 13.
    Packaging • Tablets arenicely and attractively packaged. The primary package is in direct contact with tablets. Ex: blisters • Secondary package is in direct contact with blisters Ex: boxes • Tertiary package is in direct contact with boxes. Ex. Cartons • The classification to primary, secondary or tertiary is based on what the package material contacts. Primary Package Tertiary Package Secondary Package 13
  • 14.
    Sub-departments in manufacturingplant • Maintenance 14 • Compliance • Planning Compliance team checks if processes and technicians comply to GMP standards. The team plans and sets schedules of different medicines to be produced in upcoming months. Maintenance team is present 24/7 for possibility of faulty issue either in machines or elevators.
  • 15.
     Calibration Ensure measuringdevices read correct measurements 15 Sub-departments in manufacturing plant  In-Process Control (IPC) Ensure quality of products by performing physical tests before going to the next manufacturing step
  • 16.
    Self-Assessment • 1. Whatdoes API, GMP, and IPC stand for? (3 points) • 2. What is the main difference between API and Excipients? (1 point) • 3. Mention three excipients and their functions. (3 points) • 4. List the five stages in tablet manufacturing (3 points) 16
  • 17.
    Sources 17 • Wikipedia- statistics •http://www.worldstopexports.com/drugs-medicine-exports-country/
  • 18.