PY-803 PHARMACEUTICAL ANALYSIS-III SYLLABUS

RGPV B. PHARMACY PHARMACEUTICAL ANALYSIS-III PY-803 SYLLABUS

UNIT-I

Doasage forms evaluation as per monograph with special reference to I.P.Development of new analytical methods.

UNIT-II
Concepts in validation, validation of manufacturing and analytical equipment, validation of analytical procedures.
Documentation: Protocols, forms and maintainance of records in pharmaceutical industries, preparation of documents for new drug approval and export registration to United States, United Kingdom, Europe and Africa.Patent processing and its appcations.

UNIT-III
Requirement of GLP, ISO 9000, WHO and U.S. F.D.A.

UNIT-IV
Basic concept of quality assurance, quality assurance system, sources and control of quality variation.In-process quality control tests, IPQC problems in Pharmaceutical Industries, Total quality management.

UNIT-V
Sampling plans, sampling and operating characterictics curves,Interpretation of analytical data.
Regulatory control, regulatory drug analysis.

VIII-P-3 PHARMACEUTICAL ANALYSIS –III PRACTICALS

Evaluation of dosage formulations as per I.P. monographs. Experiments based on theory.

Books Recommended
1. Willing, S. H., IV, Good Manufacturing Practices for Pharmaceuticals, Marcel Dekker Inc., New York.
2. Loftus, B. T. and Nash R., Pharmaceutical Process Validation, Marcel Dekker Inc., New York.
3. Svehla, G. Vogel’s Text Book of Micro and Semi Micro Qualitative Inorganic Analysis, Orient Longman, Hyderabad.
4. Beckett, A.H. and Stenlake, J.B., Practical Pharmaceutical Chemistry, The Athlone Press of the University of London.
5. Pharmacopoeia Of India, Ministry of Health and Family Welfare, Govt. of India, New Delhi.