PY3213 REGULATORY REQUIREMENTS IN PHARMACEUTICAL INDUSTRIES SYLLABUS | ANNA UNIVERSITY BTECH PHARMACEUTICAL TECHNOLOGY 4TH SEM SYLLABUS REGULATION 2008 2011 2012-2013 BELOW IS THE ANNA UNIVERSITY FOURTH SEMESTER B TECH PHARMACEUTICAL TECHNOLOGY DEPARTMENT SYLLABUS, TEXTBOOKS, REFERENCE BOOKS,EXAM PORTIONS,QUESTION BANK,PREVIOUS YEAR QUESTION PAPERS,MODEL QUESTION PAPERS, CLASS NOTES, IMPORTANT 2 MARKS, 8 MARKS, 16 MARKS TOPICS. IT IS APPLICABLE FOR ALL STUDENTS ADMITTED IN THE YEAR 2011 2012-2013 (ANNA UNIVERSITY CHENNAI,TRICHY,MADURAI, TIRUNELVELI,COIMBATORE), 2008 REGULATION OF ANNA UNIVERSITY CHENNAI AND STUDENTS ADMITTED IN ANNA UNIVERSITY CHENNAI DURING 2009
PY3213 REGULATORY REQUIREMENTS IN PHARMACEUTICAL INDUSTRIES
UNIT I REGULATORY CONCEPTS 9
Quality assurance – Quality control – Practice of cGMP – Schedule M – USFDA.
UNIT II REGULATORY ASPECTS 9
Pharmaceuticals – Bulk drug manufacture – Biotechnology derived products.
UNIT III INTELLECTUAL PROPERTY RIGHTS 9
Patent system – Different types of patents – Filing process of application for patent –
Infringement of patents – The patent rules 2003 as amended by the patents
(amendment) rule 2006.
UNIT IV ICH GUIDELINES 9
Quality guidelines – Impurities in new drug substances (Q3A R) – Impurities in new
drug products – Validation of analytical procedures text and methodology (Q2 R1).
UNIT V QUALITY AUDIT AND SELF INSPECTIONS 9
SOPs – Documentation – Loan license auditing – Common technical documentation
(CTD) – Drug master file (DMF).
TOTAL: 45 PERIODS
TEXT BOOKS
1. Robert, I.R., Nash, R.A., Wachter, A.H. and Swarbrick, J., “Pharmaceutical
Process Validation”, 3rd Edition, Maarcel Dekker Inc., 2003.
2. Willig, H., Tuckeman, M.M. and Hitchings, W.S., “Good Manufacturing Practices
for Pharmaceuticals”, 5th Edition, Marcel Dekker Inc., 2000.
REFERENCES
1. Subbaram, N.R., “What Everyone Should Know About Patents”, 2nd Edition,
Pharma Book Syndicate, 2005.
2. Banker, G.S. and Rhodes, C.T., “Modern Pharmaceutics”, 4th Edition, Marcel
Dekker Inc., 2002.
3. Sharma, P.P., “How to Practice GMPs”, 3rd Edition, Vandana Publications, 2006.
PY3213 REGULATORY REQUIREMENTS IN PHARMACEUTICAL INDUSTRIES
UNIT I REGULATORY CONCEPTS 9
Quality assurance – Quality control – Practice of cGMP – Schedule M – USFDA.
UNIT II REGULATORY ASPECTS 9
Pharmaceuticals – Bulk drug manufacture – Biotechnology derived products.
UNIT III INTELLECTUAL PROPERTY RIGHTS 9
Patent system – Different types of patents – Filing process of application for patent –
Infringement of patents – The patent rules 2003 as amended by the patents
(amendment) rule 2006.
UNIT IV ICH GUIDELINES 9
Quality guidelines – Impurities in new drug substances (Q3A R) – Impurities in new
drug products – Validation of analytical procedures text and methodology (Q2 R1).
UNIT V QUALITY AUDIT AND SELF INSPECTIONS 9
SOPs – Documentation – Loan license auditing – Common technical documentation
(CTD) – Drug master file (DMF).
TOTAL: 45 PERIODS
TEXT BOOKS
1. Robert, I.R., Nash, R.A., Wachter, A.H. and Swarbrick, J., “Pharmaceutical
Process Validation”, 3rd Edition, Maarcel Dekker Inc., 2003.
2. Willig, H., Tuckeman, M.M. and Hitchings, W.S., “Good Manufacturing Practices
for Pharmaceuticals”, 5th Edition, Marcel Dekker Inc., 2000.
REFERENCES
1. Subbaram, N.R., “What Everyone Should Know About Patents”, 2nd Edition,
Pharma Book Syndicate, 2005.
2. Banker, G.S. and Rhodes, C.T., “Modern Pharmaceutics”, 4th Edition, Marcel
Dekker Inc., 2002.
3. Sharma, P.P., “How to Practice GMPs”, 3rd Edition, Vandana Publications, 2006.
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