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This course is designed to impart basic knowledge and concepts of various quality management principles and systems used in the manufacturing industry. Pharmaceutical Quality Management: Fundamentals of Quality Management, Total Quality Management (TQM), Principles of Six Sigma, ISO ISO Pharmaceutical Quality Management - ICH Q10, Knowledge Management, Quality Measurements, Operational Excellence and Quality Management Review. Regulatory Compliance through Quality Management and Development of Quality Culture Benchmarking: Definition of Benchmarking, Reasons for Benchmarking, Types of Benchmarking, Benchmarking Process, Benefits of Benchmarking, Limitations of Benchmarking.

The Quality Management Sourcebook: An International Guide to Materials and Resources By Christine Avery; Diane Zabel, Routledge, 1997. Introduction, Types of Intellectual Property Rights (Patents, Trademarks, Copyrights, Geographical Indications, Industrial Designs and Trade Secrets), Patentable Subject Matter (Novelty, Non-obviousness, Utility, Empowerment and Best Mode).

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Course Objective: The topics present in the drug regulatory affairs are very useful and enhance the knowledge regarding the regulatory aspects in the pharmaceutical industry. A study of regulatory aspects affecting the design, manufacturing and distribution of pharmaceuticals in India, with special emphasis on the detailed study of the following laws (with latest amendments). A detailed study of regulatory aspects affecting the design, production and distribution of pharmaceuticals in a developed country such as the US and in a developing country such as Brazil, Hatch Waxmann Act;

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Also, it aims to provide knowledge of the basic concepts, assumptions, terminology and methods related to Pharmacoeconomics and health-related outcomes, and when appropriate the Pharmacoeconomic Model should be applied to a health care regimen. Definition, Scope, Need, Purposes and Applications; Outcome Measurement: Outcome Measures, Drug Use Measures: Monetary Units, Number of Prescriptions, Units of Drug Dispensed, Prescribed Daily Doses, Prescribed Daily Doses, Diagnosis and Therapy Surveys, Prevalence, Incidence Rate, Units monetary, number of prescriptions, unit of drugs dispensed, prescribed daily doses and prescribed daily doses, measures of medication adherence. Qualitative models: Drug use review; Quantitative models: case reports, case series, Cross-sectional studies, Cohort and case-control studies, Odds ratio calculation, meta-analysis models, Study of drug effects in populations: Spontaneous reporting, Prescription event monitoring , Postmarketing surveillance, Registry linkage systems, Pharmacoepidemiology applications.

Pharmacoeconomics Outcomes and Measurements: Types of outcomes: Clinical Outcomes, Economic Outcomes, Humanistic Outcomes; Quality-adjusted life years, Disability-adjusted life years Incremental cost-effectiveness ratio, average cost-effectiveness ratio. Definition, Steps involved, Applications, Advantages and disadvantages of the following pharmacoeconomic models: Cost Minimization Analysis (CMA), Cost Benefit Analysis (CBA), Cost.

16 Effective Analysis (CEA), Cost Utility Analysis (CUA), Cost of Illness (COI), Cost Consequences

Course objective: The topics that are present in pharmaceutical management are very useful for students in developing the personality to become a perfect pharmaceutical professional. These topics are useful for students to know how to manage a pharmaceutical industry and its various departments like QA, QC, RA, Manufacturing etc. Management helps to understand the concept of managerial control, its levels and role, importance in the pharmaceutical industry.

Fundamental concepts of production, financial, personnel, legal and marketing functions with special emphasis on pharmaceutical management. Motivational aspects, theories of motivation, group dynamics, rewards and incentives, interpersonal skills, the importance of communication, its processes, measures for effective communication, conflict management.

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The subjects help students to be exposed to processes involved in the manufacture of herbal cosmetics, including the preparation of herbal products for skin and hair care and their evaluation. Course outcomes: Students will learn about the raw materials used in herbal cosmetics and be exposed to different preparations of herbal cosmetics. Skin care products: Method of manufacture, pharmaceutical and pharmacological evaluation procedures for various formulations like creams, lotions, lipsticks, face packs.

Detailed study of five formulations under each category regarding their composition and claims for various herbs used in them. Hair care products: Method of preparation, pharmaceutical and pharmacological evaluation procedures for various formulations such as hair dyes, creams, lotions, gels, oils and shampoos. A brief description of the following plants or plant extracts or plant products of cosmetic importance such as Acacia concinna pods, Aloe Vera, Almond oil, Neem, Citrus peels, Henna, Turmeric, Licorice, Olive oil, Oil of tea tree and wheat germ oil with special emphasis on their source, active principles and cosmetic properties.

UNIT - V. a) General principles of quality control and standardization of cosmetics-Control of raw materials, Control of packaging material, control of finished product, Shelf testing.

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Quantitative Risk Assessment in Chemical Process Industries” American Institute of Chemical Industries, Center for Chemical Process safety.

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This course is designed to provide knowledge and skills necessary to train students with industrial activities during Pharmaceutical Manufacturing. Upon completion of this course, students are expected to be able to understand. Will be familiar with the principles and practices of aseptic process technology, non-sterile manufacturing technology and packaging technology.

Have a better understanding of principles and implementation of Quality by design (QbD) and process analytical technology (PAT) in pharmaceutical manufacturing. Developments in the Pharmaceutical Industry: Regulatory Requirements and Licensing for the API and Formulation Industry, Plant Location - Influencing Factors. Aseptic process technology: Manufacturing, production of flowcharts, in process quality control tests for the following sterile dosage forms: Ointment, Suspension and Emulsion, Dry powder, Solution (Small Volume & Large Volume).

Automation of processes in the pharmaceutical industry: with special emphasis on the production of sterile semi-solids, low volume parenteral drugs and large volume parenteral administration (SVP & LVP), parenteral drug production plant monitoring, cleaning in place (CIP), sterilization in place (SIP) , pre-filled syringe , powder jet, needle-free injections and form filling technology (FFS). Non-sterile manufacturing process technology: production, manufacturing flow charts, process quality control tests for the following non-sterile solid dosage forms: tablets (compressed and coated), capsules (hard and soft). Advanced non-sterile solid product manufacturing technology: automation of processes in the pharmaceutical industry with special reference to the production of tablets and coated products, improved tablet production: tablet manufacturing process, granulation and pelletizing equipment, continuous and batch mixing, rapid mixing granulators, rotary granulators, spheronizers and marbleizers and other specialized equipment for granulation and drying.

Containers and closures for pharmaceuticals: Types, performance, quality assurance of glass; types of plastic used, plastic drug interactions, biological tests, modification of plastic by drugs; various types of sealants and sealants; film wrappers; blister packs; bubble wrap; shrink wrap; foil/plastic bags, bottle seals, strip seals, frangible seals and sealed tubes; quality control of.

28 packaging material and filling equipment, flexible packaging, product package compatibility, transit

Course Objective: The student will know the introduction, scope of biostatistics and research work, calculation and presentation of the data. Course outcome: The student knows the preparation, presentation and formation of tables and graphs in biostatistics. They also know correlation and regression and application of different methods, analysis of data and also learn how to write a dissertation, thesis and research paper.

Measures of central tendency: calculation of means, median and mode from grouped and ungrouped data. Variables - Definition of variables, types of variables (dependent and independent variables, confounded variables), measurement of variables, types of measurement scales and their comparison.

30 9. References

Course objectives: The students will acquire knowledge about the various aspects of X-ray diffraction methods, all types of IR methods, particle size methods, also DSC, DTA, TGA etc. Course outcomes: At the end of the subjects, the students will come out with the in-depth knowledge of various spectral aspects of X-Ray, IR, SEM, ORD etc. which help them in further project work and also industrial opportunities. FT-NIR: Principle (overtones, combinations, Fermi resonance, interferences, etc.), instrumentation (dispersive spectrometer and FT-NIR), advantages and disadvantages, qualitative and quantitative applications, including PAT and non-destructive analysis.

ATR: Principle (total internal reflection, evanescent wave, etc.), instrumentation (ATR crystal, IR beam), advantages and disadvantages, pharmaceutical applications. Spectrofluorimetry: theory of fluorescence, factors affecting fluorescence (characteristics of drugs that can be analyzed by fluorimetry), quenchers, instrumentation and applications of fluorescence spectrophotometer. FT-Raman: Principle (absorption, diffraction, scattering and emission of waves, molecular interaction), instrumentation (Dispersive Raman, FT-Raman), advantages and disadvantages, pharmaceutical applications including counterfeit detection.

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Objective of the course: These topics are intended to impart specialized knowledge to preserve the properties of drugs and dosage forms during production storage and shelf life. Understanding properties and evaluating storage stability in solution and solid state against multiple degradation agents. Course outcome: Students must describe the evaluation of the stability of solutions, solids and formulations against adverse conditions.

Students must be able to propose measures to maintain stability and storage conditions to preserve the effectiveness of products. Oxidation: nature of oxidation, kinetics of oxidation, oxidation pathways of pharmaceutical products, interesting inhibition of oxidation. Chemical degradation of solid state: Kinetics of solid state degradation, Pharmaceutical examples of solid state degradation, Pure drugs, drug excipient and drug-drug interaction in solid state, methods of stabilization.

Analysis of drugs from biological samples, including biological sample selection, drug extraction using various methods such as LLE, SPE and membrane filtration. General analytical method for determining the quality of raw materials used in the cosmetic industry. Indian Standard Specifications (ISI) laid down by the Bureau of Indian Standards for sampling and testing of various finished cosmetic products.

Methods of analysis to determine the quality of cosmetics in the finished forms, such as hair care products, skin care products, baby care products, dental products, personal hygiene products, color cosmetics, ethnic products, color makeup preparation, lipsticks, hair setting products and Eye shadows.

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This course is designed to provide the knowledge and skills necessary to train students on business management. Upon completion of this course, students are expected to be able to understand. Requirements and challenges of Growth and Networking Strategies UNIT I. Conceptual framework Work: The concept of need and process in the development of entrepreneurship.

Development of entrepreneurial skills - requirements and understanding of the entrepreneurial development process, self-awareness, interpersonal skills, creativity, assertiveness, achievement, factors influencing the role of entrepreneur.

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Introduction to Nanotechnology

Synthesis of Nanomaterials

Biomedical applications of Nanotechnology a) Nanotechnology products used for in vitro diagnostics

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References

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