Faculty of Pharmacy

Industrial Pharmacy
Course Specification

Programme(s) on which the course is given: Bachelor Degree in Pharmaceutical Sciences

Major or minor element of programmes: Single major
Department offering the programme: Interdisciplinary
Department offering the course: Drug Technology
Academic year / Level: Third professional year- first term
Date of specification approval: 7/10 /2009

Basic Information

Title: Industrial Pharmacy

Code: 451
Credit Hours: 3/ week
Lecture: 2/ week
Tutorial: - -
Practical: 3/week
Total: 5/ week

Professional Information

1 – Overall Aims of Course

This course aims at explaining the principles of industrial pharmacy through

studying the flow of fluids, heat and mass as well as particulate solid
characteristics, importance of the unit operations such as evaporation,
distillation, drying, mixing, humidification, extraction, filtration,
centrifugation, crystallization, refrigeration, dehumidification & air
conditioning.
2 – Intended Learning Outcomes of Course (ILOS):

a- Knowledge and Understanding:

The students should be able to:

1. Define and describe the basic concepts of different pharmaceutical unit

operations performed in pharmaceutical industry like filtration, mixing
crystallization, heat transfer, evaporation, drying, extraction,
centrifugation and distillation.
2. Enumerate the factors affecting different unit operations.
3. Describe the equipment used in pharmaceutical industry.
4. Mention the different units and dimensions used in the industry.

b- Intellectual Skills
The students should be able to:

1. Determine the most suitable equipment used for each of the various unit
operations.
2. Estimate and solve problems emerging during technical operations with
respect to machine capacity and product quality.
3. Solve problems related to heat transfer, filtration and humidity using the
suitable dimensions and units.
4. Interpret the breakdown of different pharmaceutical processes and their
flow sheets.

c- Professional and practical skills

The students should be able to:

1. Use the appropriate machines safely and effectively.

2. Draw diagrams and sketches of different equipment used in
pharmaceutical industry.
3. Use appropriate units, dimensions and scientific notation.
4. Select the suitable equipment used for the different
pharmaceutical unit operations.

d- General and transferable skills

The students should be able to:

1. Demonstrate critical thinking, decision making, synthesis

and interpretation of pharmaceutical information and data,
 production of pharmacy-specific scientific documentation,
and presentation of pharmaceutical information.
2. Keep up with the pharmaceutical literature and with new
developments of the pharmacy profession and
pharmaceutical industry and appreciate the need for
independent life-long continuing education, starting the day
after the student graduates.
3. Perform online computer search to develop information
technology skills and know how to retrieve information
from a variety of sources.
4. Adopt ethical, legal and safety guidelines, plan and
implement efficient and effective working environment in
different settings contributing to organization and
management of time.
5. Apply numeric and computation methods such as natural
logarithms, exponential and mathematical functions
including differentiation and integration.

3- Contents

Topic No. of hours Lecture Tutorial/Practical

Introduction to industrial pharmacy

1 1 -
Breakdown of processes and flowsheets 1 1
Dimensions and units 3 - 3
The fundamentals of heat transfer
8 2 6
Evaporation and evaporators
5 2 3

Fluid flow and transportation of fluids 2

5 2
Mixing
8 2 6

Homogenization 2 2 -

Mass transfer and distillation

5 2 3
Extraction
4 2 2

Drying 7 4 3

5 2 3
 Humidity, air conditioning, refregeration and
gas absorption

Crystallization 4 2 2

Filtration 5 2 3
2 2 -
Centrifugation

4– Teaching and Learning Methods

ƒ Lectures (Tools: board, overhead projector, pc and data- show
projector)
ƒ Practical sessions
ƒ Assignments (Report writing)

5- Student Assessment Methods

ƒ Written exams to assess the knowledge and understanding of
intellectual and professional skills.
ƒ Oral exams to assess intellectual, general skills of analysis,
scientific thinking as well as scientific discussion.
ƒ Practical exam to assess professional and practical skills.
ƒ Periodic exams to assess the knowledge, understanding,
intellectual and professional skills.

Assessment schedule

Assessment 1 Periodic exam Week 7

Assessment 2 Practical exam Week 13
Assessment3 Written exam Week15
Assessment 4 Oral exam Week 15

Weighting of assessments
Periodic Examination 10 %
Final-term Examination 50 %
Oral Examination 20 %
Practical Examination 20%
Total 100%
 6- List of references
ƒ Course notes:
Lecture notes and practical notes of industrial pharmacy prepared by the staff
members.
ƒ Essential books:
………………
ƒ Recommended books:
Pharmaceutics : the Science of Dosage Form Design by Michael E. Aulton
(1993).
ƒ Web sites :
http://pharm.shams.edu.eg

7- facilities required for teaching and learning:

overhead projector , pc and data- show projector. Laboratory equipment and chemicals

Course coordinator:
Prof. Omaima Ahmed Sammour

Date: 7 /10 /2009

 Faculty of Pharmacy

INDUSTRIAL PHARMACY

Course Specification

Programme(s) on which the course is given: Bachelor Degree in Pharmaceutical Sciences

Major or minor element of programmes: Single major
Department offering the programme: Interdisciplinary
Department offering the course: Drug Technology
Academic year / Level: Third professional year- second term/ 400
Date of specification approval 21/2/2010.

Basic Information

Title: Industrial pharmacy

Code: 472
Credit Hours: 3/ week
Lecture: 2/ week
Tutorial: - -
Practical: 3/week
Total: 5/ week

Professional Information

1 – Overall Aims of Course

Based upon the knowledge of students gained in industrial pharmacy 451
course, the students in this course will be familiar with elements
complementary to the principles of industrial pharmacy. This will be achieved
by following up on the topics of pharmaceutical operations like water
treatment & methods of particle size reduction enlargement, separation and
analysis. Applications of such knowledge is done through studying principles
of production of dosage forms with its different types including solids, liquids
& semisolids.
2 – Intended Learning Outcomes of Course (ILO):

c- Knowledge and Understanding:

The students should be able to:

1. Describe the different machines used for the production of

pharmaceutical products.
2. Summarize and understand the whole production process of different
pharmaceutical products starting from raw materials ending with the
finished product brought into the market.
3. Enumerate the factors affecting different manufacturing problems.

d- Intellectual Skills
The students should be able to:

1. Solve problems encountered with the manufacture of tablets.

2. Solve problems related to particle size analysis& flowability of powders.
3. Estimate and solve problems emerging during technical operations with
respect to machine capacity and product quality.

c- Professional and practical skills

The students should be able to:

1. Design an appropriate experiment to measure the

flowability of powders.
2. Manufacture and evaluate certain solid dosage forms like
tablets.
3. Conduct standard industrial procedures and instrumentation
professionally.
4. Use the appropriate machines safely and effectively.
5. Draw diagrams and sketches of different machines used in
pharmaceutical industry.

d- General and transferable skills

The students should be able to:

1. Demonstrate critical thinking, decision making, synthesis
and interpretation of pharmaceutical information and data,
 production of pharmacy-specific scientific documentation,
and presentation of pharmaceutical information.
2. Keep up with the pharmaceutical literature and with new
developments of the pharmacy profession and
pharmaceutical industry and appreciate the need for
independent life-long continuing education, starting the day
after the student graduates.
3. Perform online computer search to develop information
technology skills and know how to retrieve information
from a variety of sources.
4. Adopt ethical, legal and safety guidelines, plan and
implement efficient and effective working environment in
different settings contributing to organization and
management of time.

3- Contents

Topic
No. of hours Lecture Tutorial/Practical
The Pharmaceutical Industry:
-Primary Pharmaceutical Production -
2 2
-Secondary Pharmaceutical Production

Size reduction 5 2 2

Size separation
5 2 3

8 2 6
Particle size analysis

Particle size enlargement

7 4 2

Powder flow
4 1 3

Tablets Manufacture
Introduction
Tablet formulation
Manufacturing
14 5 12
Machinary
Standards of quality
(pharmacopoeial and non
pharmacopoeial tests)
 Parentral dosage forms manufacture
1 2 -

Ophthalmic dosage forms manufacture

6 2 -

Inhalation dosage forms manufacture 2 2 -

Suppositories manufacture 5 2 -

Capsules manufacture 5 2 -

4– Teaching and Learning Methods

ƒ Lectures (Tools: board , pc and data show projector)
ƒ Discussion sessions.
ƒ Assignments (Report writing)

5- Student Assessment Methods

ƒ Written exams to assess the knowledge and understanding of
intellectual and professional skills.
ƒ Oral exams to assess general skills of analysis, scientific thinking
as well as scientific discussion .
ƒ periodic exams to assess the knowledge and understanding
intellectual and professional skills .
ƒ practical exam to assess professional and practical skills

Assessment schedule

Assessment 1 Periodic exam Week 7

Assessment 2 Practical exam Week 14

Assessment3 Written exam Week15
Assessment 4 Oral exam Week 15

Weighting of assessments
 Quizzes assignment 10 %
Final-term Examination 50 %
Oral Examination 20 %
Practical Examination 20%
Total 100%

6- List of references

ƒ Course notes:
Lecture notes and practical notes of industrial pharmacy prepared by
instructors.
ƒ Essential books:
………………
ƒ Recommended books:

1. Pharmaceutics : the Science of Dosage Form Design by Michael E.

Aulton 3rd edition (2008).
2. Tablet and capsule machine instrumentation. Peter Ridgway and Antony
Armstrong. Pharm.Press (2008)
3. Pharmaceutical production facilities. Design and applications. Graham
C.Cole 2nd edition (2006)
4. Handbook of pharmaceutical technology. L.K.Ghosh. CBS Publishers
and distributors. (2006)
ƒ Web sites :
http://pharm.shams.edu.eg

7- Facilities required for teaching and learning:

Pc and data show projector, laboratory equipment and chemicals

Course coordinator:

Prof. Omaima Ahmed Sammour

Head of department :

Prof. Omaima Ahmed Sammour

Date: 21/2/2010
 Faculty of Pharmacy

Good Manufacturing Practice (GMP)

Course Specification

Programme(s) on which the course is given: Bachelor Degree in Pharmaceutical Sciences

Major or minor element of programs: Single major
Department offering the program: Interdisciplinary
Department offering the course: Drug Technology/ Analytical chemistry.
Academic year / Level: Fourth professional year- second term/ 500
Date of specification approval: 21/2/2010.

Basic Information

Title: Good Manufacturing Practice

Code: 542
Credit Hours: 2/ week
Lecture: 2/ week
Tutorial: - 2/ term
Practical: -
Total: 2 hours/ week

Professional Information

1 – Overall Aims of Course

The aim of the course is to ensure that students have the necessary knowledge
about the inter-relationship between quality control, quality assurance and good
manufacturing practice, personnel (management, training, hygiene and health);
premises and contamination control; equipment qualification and sampling methods;
stability studies and validation as well as documentation and quality auditing in
pharmaceutical factories. Then after graduation the students should be capable to
participate with an active role in programs of good manufacturing of drugs and
assuring quality of pharmaceutical products.
2 – Intended Learning Outcomes of Course (ILOs):

e- Knowledge and Understanding:

The students should be able to:

1. State the inter-relationship between QC, QA and GMP.

2. Enumerate laws, ethics of practice of profession used during the manufacturing process.
3. Illustrate the principles and basis of good manufacturing practice , regulations to be
followed in pharmaceutical plant in order to produce products with satisfying quality.

f- Intellectual Skills
The students should be able to:

1. Assess the quality of the manufacturing operations involved in

pharmaceutical industry.
2. Diagnose problems encountered in the manufacture processes and during
the quality control of pharmaceutical preparations and finished products.
3. Comprehend and apply GPMP, GSP and GCP guidelines in pharmacy
practice.

g- Professional and Practical Skills

The students should be able to:

1. Ensure the standard quality of the finished product accurately.

2. Apply validation aspects effectively.
3. Perform quality auditing.
4. Write different documentation required to ensure the different regulatory
requirements.

d-General and Transferable Skills

The students should be able to:

 1. Plan and implement efficient and effective working environments in
pharmaceutical factories with regarding the GMP and GLP standards and
regulations.
2. Demonstrate critical thinking, decision making, synthesis and
interpretation of pharmaceutical information and data, production of
pharmacy-specific scientific documentation, and presentation of
pharmaceutical information.
3. Keep up with the pharmaceutical literature and with new developments
of the pharmacy profession and pharmaceutical industry and appreciate
the need for independent life-long continuing education, starting the day
after the student graduates.
4. Perform online computer search to develop information technology skills
and know how to retrieve information from a variety of sources.

3- Contents

Topic No. of hours Lecture Tutorial/Practical

Introduction. 1 1 -
The inter relationship between quality control, quality assurance and
GMP
Personnel. 2 2 -
ƒ PERSONAL Management
ƒ PERSONAL Training
PERSONAL Hygiene and health
Premises and contamination control 2 2 -
ƒ Premises: Location, design, structure, layout, services,
cleaning
Contamination types and sources
Documentation 2 2 -

Quality auditing 2 2

-
Regulatory aspects 1 1
Validation 3 3 -
ƒ Types of validation
ƒ Applications
ƒ Case studies

Technology transfer 1 1 -

High purity water 1 1 -

Introduction and sampling methods 3 3 -

Validation of analytical methods. 3 3 -

Equipment qualification. 3 3 -

Drug stability, stability studies and stability 4 4 -

indicating methods.

4– Teaching and Learning Methods

ƒ Lectures.(Tools: board, pc and data show).
ƒ Discussion sessions.
ƒ Assignments (Report writing).

5- Student Assessment Methods

o Written exam to assess knowledge and understanding of intellectual
and professional skills detailed in items 2a, 2b&2c.
o Oral exams to assess general skills of analysis, scientific thinking as
well as scientific discussion detailed in item 2d.
o Periodic exam(quizzes) to assess knowledge and intellectual skills
detailed in items 2a&2b.

Assessment schedule
Assessment 1 Periodic exam Week 7
Assessment 2 Written exam Week 15
Assessment 3 Oral exam Week 15

Weighting of assessments
Periodic examination 20 %
Final-term written examination 60 %
Oral Examination 20 %
Total 100%

6- List of references

- Course notes
Lecture notes on Good Manufacturing Practice prepared by instructors
 - Recommended books

• Good Manufacturing Practice for Pharmaceuticals ( A plan for total quality

control). By Sidney H. Willing, James R. Stoker, 1997, 4th edition , Marcel
Dekker, U.S.A.

• Pharmaceutical process validation. By R.A. Nash and A.H. Wachter, 2003,

Marcel Dekker, U.S.A.

• Quality in the manufacture of medicines and other health care products. By

J. Sharp, 2000, Pharmaceutical press.

• Pharmaceutical production facilities. Design and applications. Graham

C.Cole 2nd edition (2006)

• Rules and guidance for pharmaceutical manufacturers and distributors, 2007

Pharmaceutical press.

7- Facilities required for teaching and learning

Study halls, Data show, books, audiovisual tools & Internet

-Course coordinators:

Prof. Omaima Ahmed Sammour and Prof. Amira El Kasas

Head of department :

Prof. Omaima Ahmed Sammour and Prof. Amira El Kasas

Date: 21/2/2010
 Faculty of Pharmacy

Planning, Marketing and Economics of Drugs

Course Specification

Programme(s) on which the course is given: Bachelor Degree in Pharmaceutical Sciences

Major or minor element of programs: Single major
Department offering the program: Interdisciplinary
Department offering the course: Drug Technology
Academic year / Level: Fourth professional year- second term/ 500
Date of specification approval: 21/2/2010

Basic Information

Title: Planning, Marketing and Economics of Drugs

Code: 603
Credit Hours: 3/ week
Lecture: 3/ week
Tutorial: -
Practical: -
Total: 3 hours/ week

Professional Information

1 – Overall Aims of Course

This course aims at deepening the concept of planning ,economics and marketing of
pharmaceutical products . Studying principles of planning, marketing and pharmacoecomics
and the application of such knowledge in the pharmaceutical market will be achieved by
studying aims ,strategies & procedures of planning. Then marketing will be handeled from the
perspective of characteristics of drug market , strategies of marketing , distribution of
pharmaceuticals and pricing of drugs in addition to methods of forecasting and assessment.
This course also stresses on studying drug economics including some economical principles
related to drug product and the philosophy of products and services. Students will learn the
assessment of economical methods with necessary application in the field of drugs, drug
products and health together with some related problems to be solved. As well as practical
aspects of the subject.

2 – Intended Learning Outcomes of Course (ILOs):

h- Knowledge and Understanding:

The students should be able to:

1. Define the basic principles of marketing of pharmaceuticals.

2. Compare and differentiate between the different economical assessment
methods applied in the field of pharmaceuticals and treatment
intervention.
3. Comprehend administrative and economical aspects of pharmaceuticals,
marketing of medicines, principles of management, financial and human
resources, drug promotion as well as accounting.
4. Comprehend application of pharmacoeconomics to pharmacy services
and medical therapeutics.
5. Comprehend social, behavioral and environmental sciences and health
policy relevant to pharmacy.

i- Intellectual Skills
The students should be able to:

1. Apply different strategies of marketing to different pharmaceutical

products & evaluate the effectiveness of each strategy.
2. Implement marketing principles to position different pharmaceuticals to
maximize sales.
3. Implement pharmacoeconomic skills to solve relevant problems in the
treatment programmes.
 4. Apply the principles of pharmacoeconomics in promoting cost/ effective
pharmacotherapy.

j- Professional and Practical Skills

The students should be able to:

1. Solve economical problems of drugs with a

multidisciplinary and integrative approach.

d-General and Transferable Skills

The students should be able to:
1. Develop financial, sales and market management skills.
2. Demonstrate critical thinking, decision making, synthesis
and interpretation of pharmaceutical information and data,
production of pharmacy-specific scientific documentation,
and presentation of pharmaceutical information.
3. Keep up with the pharmaceutical literature and with new
developments of the pharmacy profession and
pharmaceutical industry and appreciate the need for
independent life-long continuing education, starting the
day after the student graduates.
4. Perform online computer search to develop information
technology skills and know how to retrieve information
from a variety of sources.
5. Apply numeric and computation methods such as natural
logarithms, exponential and mathematical functions
including differentiation and integration.
6. Adopt ethical, legal and safety guidelines, plan and
implement efficient and effective working environment in
different settings contributing to organization and
management of time.

3- Contents

Topic No. of hours Lecture Tutorial/Practical

The economic problems I 2 2 -

The economic problems II 2 2 -

Economics of business I 2 2 -

Economics of business II 2 2 -

Pharmacoeconomics (overview) 2 2 -

Pharmacoeconomics (models) 2 2 -

Pharmacoeconomics (methodologies I) 2 2 -

Pharmacoeconomics (methodologies II) 2 2 -

Pharmacoeconomics (methodologies III) 2 2 -

Decision analysis I 2 2 -

Decision analysis II 2 2 -

Practical applications I 2 2 -

Practical applications II 2 2 -

Practical applications III 1 1 -

The pharmaceutical market 1 1 -

Marketing strategy 2 2 -

Distribution Strategy 2 2 -

Pricing strategy 2 2 -

Communication strategy 2 2 -

Forcasting, planning and evaluating marketing 2 2 -

performance

Practical aspects I 2 2 -

Consume behaviour 1 1

Practical aspects II 1 1 -

4– Teaching and Learning Methods

- Lectures (Tools: board, data show).
- Discussion sessions.
 - Assignments (Report writing)

5- Student Assessment Methods

ƒ Written exams to assess the knowledge and understanding
intellectual and professional skills .
ƒ Oral exams to assess general skills of analysis, scientific thinking
as well as scientific discussion .
ƒ Periodic exams to assess knowledge and intellectual skills .

Assessment schedule

Assessment 1 Periodic exams Week 7

Assessment 2 Written exam Week 15
Assessment 4 Oral exam Week 15

Weighting of assessments
Periodic exams 20 %
Final-term written Examination 60 %
Oral Examination 20 %
Total 100%

6- List of references

ƒ Course notes
ƒ Hand outs of Planning, Marketing and Pharmacoeconomics prepared by
instructors.
ƒ Pharmaceutical Marketing by A.F. Taher Ph.
ƒ Essentials of pharmacoeconomics. Karen L. Rascati. Lippincott Williams
and Wilkins (2009)

ƒ Essential books:
………………
ƒ Recommended books

…………….

7- Facilities required for teaching and learning

Study halls, audiovisual aids, books.

Course coordinator:
Prof. Dr. A. Elshami

Head of department :

Prof. Dr. Omaima Ahmed Sammour

Date: 21/2/2010