Analytical Method Validation and Copyrights and Trademarks Detailed Syllabus for Pharmaceutical Management And Regulatory Affairs M.Pharm first year second sem is covered here. This gives the details about credits, number of hours and other details along with reference books for the course.
The detailed syllabus for Analytical Method Validation and Copyrights and Trademarks M.Pharm 2017-2018 (R17) first year second sem is as follows.
M.Pharm. I Year II Sem.
Course Objective: The students will know the validation guidelines, different methods of validation, implementation of validation. They also know about the law related to copyrights, trademarks and their implementation
Course Outcome: Students will get knowledge about ICH guidelines for validation, FDA drafts and techniques which are used for validation and their implementation. They also know the rights and laws related to copyrights and trademarks.
UNIT I : Validation guidelines
- ICH Q2A: Text on validation of analytical procedures: Definitions and terminology (March 1995)
- ICH Q2B: Validation of analytical procedures: Methodology (June 1997)
- FDA: (Draft) Guidance for Industry: Analytical procedures and methods validation
- Pharmacopoeias: USP and European Pharmacopoeia
UNIT II : What methods to be validated?
Defined for:
- Identification
- Quantitative tests for content of impurities
- limit tests for control of impurities
- Quantitative tests for active moiety in drug substances and drug products
Referred to:
- Dissolution testing
- Particle size determination (drug substance)
UNIT III : Implementation of Guidelines
- Standard protocols
- Set up as procedures
- Mutual agreement on tests
- Mutual agreement on criteria
- Mutual agreement on documentation ==> MUTUAL DEVELOPMENT PROCEDURES (MDP)
UNIT IV :
- Copyright: Law relating to copyright in India. Copyright Act, 1957and its amendments. Subject matter of copyright protection. Rights of owners of copyrights. Infringement of copyright, remedies against infringement of copyright. Authorities and institutions under the copyright Act.
- Trademarks: The trademarks legislation in India. Service marks, certification Marks, Collective marks, Distinctiveness of Trade Marks, Distinct Marks. Subject matter of Trade marks. Acquisition of registered Trade Mark. Register and conditions for Registration. Infringement of Trade marks.
UNIT V : Trade mark laws and governing of trademarks, role of Indian trade mark office.
TEXT BOOKS:
- Ira R. Berry and R.A. Nash ( eds ) Pharmaceutical Process Validation, Marcel Dekker Inc, New York
- Pharmaceutical Process Validation by Loftus and Nash.
- Remington’s Pharmaceutical Sciences, The science and practice of pharmacy, 20th Edition, Vol. I & II.
- Quality Assurance of Pharmaceuticals –A compendium of guidelines- WHO publication.
- Theory and practice of industrial pharmacy by Liberian and Lachman.
- Pharmaceutical Process validation by Berry and Nash.
- Intellectual properties rights by GB Reddy.
REFERENCE BOOKS:
- GMP by Sidney Herbal, Willing.
- Quality Assurance Guide – Organization of Pharmaceutical products of India.
- Drugs and Cosmetics Act 1969 and Rules 1945.
- S.H. Willing M. M. T. Tuckerman, W. S. Hitchings IV, Good Manufacturing Practices for Pharmaceuticals, Marcel Decker Inc, M. New York.
- P.P. Sharma, How to practice GMP’s Vandhana Publications, Agra
- Lippincott Williams Wilkins, Philadelphia, 2000
- Quality assurance guide supplied by Organization of Pharmaceutical procedure of India.
For all other M.Pharm 1st Year 2nd Sem syllabus go to JNTUH M.Pharm Pharmaceutical Management And Regulatory Affairs 1st Year 2nd Sem Course Structure for (R17) Batch.
All details and yearly new syllabus will be updated here time to time. Subscribe, like us on facebook and follow us on google plus for all updates.
Do share with friends and in case of questions please feel free drop a comment