Minia University Faculty of Pharmacy
Course Specification
Quality Control of Drugs
5th Year Pharmacy students
جمانرب سويرولاكب
لديصلا ي
ة ( ةحئلا 6
) 201
University: Minia Faculty : Pharmacy
Department: Analytical Chemistry
Program: Clinical pharmacy students
1- Administrative Information
Course Title:
Quality Control of Drugs
Code:
PA518
Academic Year/level:
5th year Pharmacy students/ first semester
Department(s) offering the course:
Analytical Chemistry
Lecture:… 1 hr/week (X12 week= 12 hrs/semester) Practical 2 hrs/week (x12 week~24 hrs/semester) Total: … 36 hr/year…
2- Aims (Module purpose)
The aim of this course is to:
1. Introduction
to quality control and quality assurance,
2.
sampling,
3.
documentation storage and hazardous materials,
4.
validation of analytical methods
5.
stability indicating.
3- Overall aims of Course:
A- Knowledge
A1-Provide a critical evaluation of methods available for detectingةيليلحتلا ءايميكلا مسق
Analytical Chemistry Department
and
Understanding
and/or quantifying a range of analytes and their degradation products A2-Gain knowledge about the chemical stability of pharmaceutical
products and different method used in the stability testing
A3-Understand the importance & advantages of quality control and quality assurance in the pharmaceutical analysis.
A4- Gain knowledge about the validation of analytical methods used in the analysis.
B- Intellectual Skills:
B1- Improve the ability of scientific thinking and using the studied information properly in the fields of pharmaceutical analysis.
B2- Solve problems concerning quantitative determination of active constituents in bulk and pharmaceutical products.
B3- develop an understanding of the selection and the applicability of different techniques by reflection on taught material and hence to suggest appropriate strategies for developing analytical methods.
B4- Analyze and evaluate the analytical information to the pharmaceutical compounds needed in pharmacy practice.
B5- Interpret and explain the different parameters concerning analytical method validation
B6- Improve the ability to create method suitable for stability testing using different techniques.
C- Professional and Practical Skills:
C1- Use the different analytical instruments such as pH meter, Spectrofluorimeter, Spectrophotometers ….etc.
C2-Evaluate the analytical data.
C3-Learn and practice lab techniques, lab safety and pharmaceutical calculation.
C4-Evaluate the performance and calibration of instruments used in pharmaceutical analysis,
C5-Learn and validate an analytical procedure.
C6-Develop proper skills to keep up with the requirements for pharmacy professional position in Industry, such as quality control and quality assurance of pharmaceutical products, and also raw materials
D- General and transferable skills:
D1-Utilize computers to get and use on-line data base and improve professional competencies.
D2-.Give oral presentations.
D3-Plan and manage a scientific project.
D4- Write detailed reports on analysis of sample.
4- Course Contents:
Topic Practical Lecture No. of hours
Quality control and quality assurance, in -- 2 2
pharmaceutical analysis
Sampling process in pharmaceutical analysis 2 2 8
documentation storage and hazardous materials, 1 8
Validation of analytical methods 12 3 14
Stability and stability testing of drugs and pharmaceutical product.
10 4 14
Total 24 36 60
Matrix I- Coverage of the course ILOs by different topics
D- general and transferable skills C- Professional and practical
skills:
B- Intellectual skills:
ge and Knowled - A
Understanding Topics
D 4 D 3 D 2 D 1 C 6 C 5 C 4 C 3 C 2 C 1 B 6 B 5 B 4 B 3 B 2 B 1 A 4 A 3 A 2 A 1
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● Quality control and ●
quality assurance,
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● Sampling
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● documentation storage ●
and hazardous materials,
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● Validation of analytical ●
methods
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● Stability and stability testing of drugs and pharmaceutical product.
Matrix II- Coverage of the course ILOs by different learning methods
D- general and transferable skills C- Professional and practical
skills:
B- Intellectual skills A-Knowledge and
Understanding
Teaching and learning
method
D4 D3 D2 D1 C6 C5 C4 C3 C2 C1 B6 B5 B4 B3 B2 B1 A4 A3 A2 A1
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● Lecture
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lessons
5- Teaching and Learning Methods:
Lecture: Computer, data show, white board, marker Practical:
White board, marker, laboratory chemicals, laboratory glassware.
6- Teaching and Learning Methods: to Students with Limited Capacity
The same as given under teaching and learning methods. In addition encourage them to attend office hours and to solve problem sets in the available books.
7- Student Assessment Methods:
1. Written examination to assess the ability of student to understand the theoretical courses.
2. Oral examination to assess the ability of student to explain and solve problems.
3. Practical examination to assess the ability of student to deal with practical problems
4. Assignments to assess the ability to write a scientific report.
Matrix III- Coverage of the course ILOs by different Assessment methods
D- general and transferable skills
C- Professional and practical skills:
B- Intellectual skills:
A-Knowledge and Understanding
Assessment method
D4 D3 D2 D1 C6 C5 C4 C3 C2 C1 B6 B5 B4 B3 B2 B1 A4 A3 A2 A1
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● Written
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● oral
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● Practical
Assessment Schedule:
Assessment 1: Practical exam in the 13th week.
Assessment 2: Sheet in the 11th week
Assessment 3: Med-term exam in the 7th week.
Assessment 4: Written exam in the 14th week Assessment 5: Oral exam in the 14th week
Weighting of Assessment:
Written exam 50 %
Practical exam 25 %
Med-term exam 10
Oral exam. 15 %
Total 100%
8- List of References:
A- Course Notes
B- Essential Books: 1. Encyclopedia of Analytical Chemistry, 1999-
Writt Practi en
cal Med-
term Oral
2010 by John Wiley and Sons, Inc.
2. Fundamental of analytical chemistry, Skoog 3. Quantitative Analytical Chemistry, Flashka,
1969.
4. Harris, D.C. Quantitative Chemical Analysis (2007).
Publisher: W H Freeman. 7th Ed.
5. Validation and qualification in analytical laboratories, Ludwig Huber, 2nd Edn., Informa heathcare, NY 2007.
C- Recommended Books: 1.
Analytical chemical Acta
2. Journal of Biomedical and pharmaceutical analysis 3.
Analytical Chemistry (journal)
Others
D- Periodicals, Web sites, etc.
