Quality Assurance in Pharmaceutical Industries detailed syllabus for Pharmacy (Pharma) for 2021 regulation curriculum has been taken from the Anna Universities official website and presented for the Pharma students. For course code, course name, number of credits for a course and other scheme related information, do visit full semester subjects post given below.
For Pharmacy 5th Sem scheme and its subjects, do visit Pharma 5th Sem 2021 regulation scheme. For Professional Elective-III scheme and its subjects refer to Pharma Professional Elective-III syllabus scheme. The detailed syllabus of quality assurance in pharmaceutical industries is as follows.
Course Objectives:
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Unit I
GOOD LABORATORY PRACTICE 9
Concept and evolution and scopes of Quality Control and Quality Assurance. Good Laboratory Practices: Scope of GLP, The principles of good laboratory practice, Test facility management, Quality assurance programme, protocol for conduct of non-clinical testing, CPCSEA guidelines.
Unit II
ANALYSIS OF RAW MATERIAL 9
Developing specification for new drug substances, new drug products and impurities as per ICH Q6 and Q3.
Unit III
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Unit IV
QUALITY ASSURANCE 9
Quality assurance of finished products – tablets, capsules, ointments, parenteral, creams according to Indian Pharmacopoeias.
Unit V
GUIDANCE FOR INDUSTRY PAT 9
Guidance development process and scope, process understanding-principles and tools – PAT tools-Risk based approach-Integrated systems approach-Real time release – strategy for implementation- PAT regulatory approach.
Course Outcomes:
- Apply GLP regulation in pharmaceutical manufacturing.
- Perform an experiment using modern equipment’s in identifying the drug substance, drug products and impurities.
- Design and develop process to ensure the critical systems in pharmaceutical industries and products.
- Demonstrate the different assessments involved in the finished products.
- Understand the principle and process involved in the process analytical technology
- Understand the various regulations, modern methods and assessment techniques in maintaining the quality of the product in pharmaceutical industries.
Text Books:
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Reference Books:
- Root Cause Analysis, The Core of Problem Solving and Corrective Action, Duke Okes, 2009, ASQ Publications.
- Good laboratory Practice Regulations – Allen F. Hirsch, Volume 38, Marcel Dekker Series, 1989.
- The drugs and cosmetics act 1940 – Deshpande, Nilesh Gandhi, 4 th edition, Susmit Publishers, 2006.
- Sarker DK. Quality Systems and Controls for Pharmaceuticals. John Wiley & Sons; 2008
For detailed syllabus of all the other subjects of Pharmacy 5th Sem, visit Pharma 5th Sem subject syllabuses for 2021 regulation.
For all Pharmacy results, visit Anna University Pharma all semester results direct link.