Validation in Pharmaceutical Industries Pharma 6th Sem Syllabus for B.Tech 2017 Regulation Anna Univ (Professional Elective II) detail syllabus for Pharmacy (Pharma), 2017 regulation is collected from the Anna Univ official website and presented for students of Anna University. The details of the course are: course code (PY8005), Category (PE), Contact Periods/week (3), Teaching hours/week (3), Practical Hours/week (0). The total course credits are given in combined syllabus.
For all other pharma 6th sem syllabus for b.tech 2017 regulation anna univ you can visit Pharma 6th Sem syllabus for B.Tech 2017 regulation Anna Univ Subjects. For all other Professional Elective II subjects do refer to Professional Elective II. The detail syllabus for validation in pharmaceutical industries is as follows.
Course Objective:
- To provide the information on GMP/GLP regulation involved in the manufacturing OfAPI and biological products.
- To provide the importance of impurity profile and stability testing of drugs.
Unit I
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Unit II
Impurities in Drug Substances and Drug Products
Definition of impurities-Validation and impurity issue related to manufacturing -Processing of drug substances -Enantiomers as impurities -Polymorphs as unwanted components.
Unit III
Cleaning Procedure Inapimanufacturingfacilities
Regulatory requirements-Multiple vs dedicated equipment- Unique nature of API-Multiple level approach to cleaning-Nature of contaminants-Selection of a worst case-Cleaning techniques -Sampling – Analytical methods – Limits and acceptance criteria, documentation.
Unit IV
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Unit V
Process Validation
Process validation as a quality assurance tool-General QA tools, purpose of process validation, Qualification activities, Process validation activities. Prospective process validation-Organization, documentation, product development, development of manufacturing capability, full scale production development, defining experimental programs, experimental design and analysis.
Course Outcome:
The students will be able to
- Understand regulatory practices and administrative functions adopted in the Pharmaceutical organizations.
- Understand the importance of impurity and the procedure for determination of expiry date.
- Understand the role of cleanliness in manufacturing high purity products and reducing adverse products
Text Books:
- R.A. Nash, A.H. Wachter, Pharmaceutical Process Validation, 3rd ed., CRC Press, Taylor and Francis Group, 2003.
- Y. Anjaneyulu,R.Maraya, Quality Assurance and Quality Management in PharmaceuticalIndustry,PharmaBookSyndicate,2005.
- J. P. Agalloco,F.J. Carleton, Validation of Pharmaceutical Processes, 3rd ed., Informa Healthcare, NY, USA, 2007.
References:
- Willig,S.H., Good Manufacturing Practice for Pharmaceuticals, 5th Edition, MarcelDekker,2005.
- A.A. Signore, T. Jacobs, Good Design Practices for GMP Pharmaceutical Facilities 1st ed., CBS Publishers and Distributors Pvt. Ltd., 2009.
- S.C. Chow, Statistical Design and Analysis of Stability Studies Chapman and Hall/CRC, 2007.
For detail syllabus of all other subjects of B.Tech Pharma, 2017 regulation do visit Pharma 6th Sem syllabus for 2017 Regulation.
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