Quality Control and Quality Assurance of Pharmaceuticals

1. Quality Control and Quality Assurance of
Pharmaceuticals
Sapan K. Shah
Assistant Professor, Department of Pharmaceutical Chemistry,
Priyadarshini J. L. College of Pharmacy, Nagpur
Email: shah.sapan@rediffmail.com
PHARMACY PRACTICE SCHOOL
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2. Email: shah.sapan@rediffmail.com
Course Overview
 In the VII semester, every candidate shall undergo practice school for a
period of 150 hours evenly distributed throughout the semester.
 The student shall opt any one of the domains for practice school
declared by the program committee from time to time.
 At the end of the practice school, every student shall submit a printed
report (in triplicate) on the practice school he/she attended (not more
than 25 pages).
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3. Email: shah.sapan@rediffmail.com
Course Overview
 WHO directions says “make sure that the drugs and devices made
should meet acceptable standards of quality, safety and efficacy”.
 Goal of quality control is to ensure that the products, services, or
processes meet specific requirements and are dependable,
satisfactory, and fiscally sound.
 The quality has to be incepted and maintained into the product from
the start to the end.
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4. Email: shah.sapan@rediffmail.com
Course Overview
• Safety and
Regulatory
Standards
• Enviromental
• Examination
of Process
• Examination
of Product
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5. Email: shah.sapan@rediffmail.com
Course Objectives
 The goal of preparing and making ready experienced
professionals from the industry which after attending the
pharmacy school on this course will have better and clearer
view of the quality testing methods, tools and fixing
techniques.
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6. Email: shah.sapan@rediffmail.com
Career Opportunities
 This course will help students to understand and implement
quality assurance and quality control for the particular
operation during drug development.
 The course helps in better understanding of drug
development process and its importance in the Pharma
Industry and appraise them for following careers.
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7. Email: shah.sapan@rediffmail.com
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8. Email: shah.sapan@rediffmail.com
Source: Jiangsu Hankuo Biology Co., Ltd.
Quality
Assurance
Engineer
Quality
Assurance
or Control
Managers
Quality
Researcher
Quality
Assurance
Technicians
or Analysts
Quality
Assistant
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9. Email: shah.sapan@rediffmail.com
Course Design
1. Introduction to analytical
techniques.
2. Quality Assurance
and Quality Control
in pharmaceutical
industry
3. International perspective of
(USA, WHO, ICH & Europe /
India etc).
4. Preparations of SOPs
Module 1
Introduction
Potentiometer
Conductometer
UV spectrometer
HPLC
HPTLC
FES
Fluorimeter
Module 2
Instruments
Handling
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10. Email: shah.sapan@rediffmail.com
Module 3
Industrial Aspects
of QA & QC
Calibration of
glassware,
Calibration of
analytical
instruments
Preparation of
analytical reagents
and working
standards
Monograph analysis of
pharmaceuticals
Analytical method
development and
Validation
Module 4:
Documentation
•Documentation in
pharmaceutical
industry:
Module 5:
Assignment
• Printed report
(in triplicate) on
the practice school
he/she attended
(not more than 25
pages)
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11. Email: shah.sapan@rediffmail.com
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