St Aloysius (Deemed to be University) LMS | Quality Assurance and Quality Control

Course / Course Details

Quality Assurance and Quality Control

By - Dr Shreelalitha Suvarna
63 students
30 Hours
(0)

Course Requirements

Course Description

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, 2^nd ed., New Delhi: Vallabh Prakashan.

9. Sharma, P. P. (2004). How to Practice GMPs, 4^th 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.