Course / Course Details
By - Dr Shreelalitha Suvarna
SYLLABUS
Quality
Assurance and Quality Control
Module 1:
(15 hrs)
Use of the quality
systems approach within the pharmaceutical industry such as Total Quality
Management and Process steps of Total Quality Management (TQM). ISO 9000, ISO
14000, ICH GCP and Schedule Y.
Module II: (15 hrs)
Historical background, Good
Laboratory Practices (GLP), Historical background and principles of GMP, Current
Good Manufacturing Practices (cGMP) and Good documentation practices (GDP)
Mode
of Evaluation: Test-02 & Assignment-02 (Each module)
REFERENCES:
1.
Cooper,
B. N. (2017). Good Manufacturing Practices for Pharmaceuticals-GMP in Practice.
California: Create Space Independent Publishing Platform.
2.
James,
P. A., & Frederick, J. C. (2007). Validation of Pharmaceutical Processes,
New York: CRC Press.
3.
Jordi,
B. (2015). Good Quality Practice (GQP) in Pharmaceutical Manufacturing: A
Handbook, United Arab Emirates: Bentham Science Publishers.
4.
McCormick,
K. (2002). Quality, Pharmaceutical Engineering Series, Oxford: Butterworth- Heinemann.
5.
McDowall,
R. D. (2018). Data Integrity and Data Governance Practical Implementation in
Regulated Laboratories, United Kingdom: Royal Society of Chemistry.
6.
Nancy,
R. T. (2005). The Quality Toolbox, United States of America: ASQ Quality Press.
7.
Rick,
N. G. (2004). Drugs from discovery to approval. New Jersey: John Wiley &
Sons.
8.
Subrahmanyam,
C. V. S. (2015). Pharmaceutical Production and Management, 2nd ed.,
New Delhi: Vallabh Prakashan.
9.
Sharma,
P. P. (2004). How to Practice GMPs, 4th ed., Delhi: Vandana
Publications Pvt. Ltd.
10.
Syed,
I. H. (2002). Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA,
GMP, and GLP Compliance, United States: St. Lucie Press.
Beginner
Discover Additional Learning Opportunities
Static