Birla Institute of Technology & Science, Pilani

Work-Integrated Learning Programmes Division

Second Semester 2016-17

Course No. : POM ZG522

Course Title : Quality Assurance and Regulatory Affairs

Course Instructor : Dr. Aniruddha Roy

Course Description

Quality control, quality assurance, quality management, various parameters for achieving
quality pharmaceutical products, application of statistics in quality assurance, reliability, current
good manufacturing practice (cGMP) for pharmaceutical manufacturing, pharmaceutical
process validation, drug regulatory affairs, clinical research protocols, new drug applications,
drug product labeling.

Scope and Objective

Quality control, assurance and management, various parameters for achieving quality pharmaceutical
products, application of statistics in quality assurance, reliability, cGMP for pharmaceutical
manufacturing , pharmaceutical process validation, drug regulatory affairs , new drug applications.

Prescribed Text Book:

T1. Sidney H. Willig, Murray M. Tuckerman and William S. Hitchings IV, " Good Manufacturing
Practices for Pharmaceuticals: A Plan for Total Quality Control" Marcel Dekker, New York,
4th Edn., Vol. 78, 1997.

T2. Bernard T. Loftus and Robert A. Nash, " Pharmaceutical Process Validation" Marcel Dekker,
New York, 2nd Edn., Vol. 57, 1993.

Reference Books :
R1. Richard A. Guarino, " New Drug Approval Process" Marcel Dekker, New York, 2nd Edn.,
Vol. 56, 1993.

R2. Dale H. Besterfield, Quality ControlPrentice Hall International Inc., New Jersey, 5th Edn.,
1998.

R3. Sandy Weinberg, Good Laboratory Practices Marcel Dekker, New York, 2nd Edn., Vol. 69,
1995.

R4. Leon Lachman, Herbert L. Lieberman and Joseph L. Kanig " The Theory and Practice of
Industrial Pharmacy" Varghese Publn., Bombay, 3rd Edn., 1987.

R5. U.S. Pharmacopeia, U.S. Pharmacopeial Convention Inc., Rockville, MD, 23rd Edn., 1995.
POM ZG522 (Course Handout) Second Semester 2016-2017 Page 2

Lecture Plan and Plan of Study

Week Topics Reference to

No. Text Book

1-2 Drug Discovery and Development: R1Ch.1-3, 5,

10, 11
New Drug Approval Process

a) Pre-clinical studies

b) Brochure preparation for IND & ANDA

c) Clinical Trials

3-4 Overview of quality control and validation process in a T1- Chapter 1

pharmaceutical industry.
Class notes
Interrelation of factors influencing quality and customer acceptability
of Pharmaceutical products

5-8 Quality improvement techniques R2 Ch. 3-9

Application of statistical approaches for quality control

9 Review Session

Syllabus for Mid-Semester Test (Closed Book): Topics in Week No. 1 to 8

10-11 Concepts and tools for effective implementation of TQM R2 Ch. 13

12-13 Good Manufacturing Practices in the Pharmaceutical industry: T1 Ch. 3-13

a) Organization & Personnel

b) Buildings & Facilities

c) Equipment

d) Components, Containers & Closures

e) Production & Process control

f) Packaging & Labeling control

g) Laboratory controls- Reports & Records

h) Return Goods & Relabeling

14-15 Process and significance of ISO certification, Quality audit (means Class notes
and mechanism) as a tool for manufacturing and quality control
system development

15-17 Understanding the significance and implementation of Good R3 Ch. 2

Laboratory Practices (GLP)
 Pharmaceutical Process Validation

a) Organization

b) Pharmaceutical Products (Solid dosage forms and Sterile T2 Ch. 2-9

products)

c) Prospective validation

d) Retrospective validation & Analysis

e) Raw material validation

f) Analytical method validation

18 Review Session

Syllabus for Comprehensive Exam (Open Book): All topics given in Plan of Study

Evaluation Scheme:
Legend: EC = Evaluation Component; AN = After Noon Session; FN = Fore Noon Session
No Name Type Duratio Weight Day, Date, Session, Time
n
EC-1 Quiz-I/ Assignment-I Online - 5% February 1 to 10, 2017

Quiz-II Online 5% March 1 to 10, 2017

Quiz-III/ Online 5% March 20 to 30, 2017

Assignment-II
EC-2 Mid-Semester Test Closed 2 hours 35% 25/02/2017 (FN) 10 AM to 12 Noon
Book
EC-3 Comprehensive Open 3 hours 50% 08/04/2017 (FN) 9 AM 12 Noon
Exam Book

Important links and information:

Elearn portal: https://elearn.bits-pilani.ac.in
Students are expected to visit the Elearn portal on a regular basis and stay up to date
with the latest announcements and deadlines.
Contact sessions: Students should attend the online lectures as per the schedule
provided on the Elearn portal.
Evaluation Guidelines:
1. EC-1 consists of either two Assignments or three Quizzes. Students will attempt
them through the course pages on the Elearn portal. Announcements will be
made on the portal, in a timely manner.
2. For Closed Book tests: No books or reference material of any kind will be
permitted.
3. For Open Book exams: Use of books and any printed / written reference material
(filed or bound) is permitted. However, loose sheets of paper will not be allowed.
Use of calculators is permitted in all exams. Laptops/Mobiles of any kind are not
allowed. Exchange of any material is not allowed.
4. If a student is unable to appear for the Regular Test/Exam due to genuine
exigencies, the student should follow the procedure to apply for the Make-Up
Test/Exam which will be made available on the Elearn portal. The Make-Up
Test/Exam will be conducted only at selected exam centres on the dates to be
announced later.
It shall be the responsibility of the individual student to be regular in maintaining the self
study schedule as given in the course handout, attend the online lectures, and take all
the prescribed evaluation components such as Assignment/Quiz, Mid-Semester Test and
Comprehensive Exam according to the evaluation scheme provided in the handout.