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    LTR Thund 3

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    laluroshan123
    Life science comprises all scientific studies related to living organisms including plants, animals, and humans. It includes fields like biology, biochemistry, biotechnology, genetics, and other branches of science and technology related to biology. The life science industry includes organizations researching, developing, manufacturing, and distributing pharmaceuticals, biotechnology products, medical devices, and other areas. Major activities include active ingredient development, generic and OTC drug manufacturing, formulation, bio-pharmaceutical development, and contract research. Key divisions are pharmaceuticals and biopharma, biotechnology, medical devices, and contract research organizations. Drug regulatory agencies are responsible for licensing, regulating, and monitoring life science industries and companies to ensure safety, efficacy, and quality.

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    LTR Thund 3

    Uploaded by

    laluroshan123
    8 views2 pages
    Life science comprises all scientific studies related to living organisms including plants, animals, and humans. It includes fields like biology, biochemistry, biotechnology, genetics, and other branches of science and technology related to biology. The life science industry includes organizations researching, developing, manufacturing, and distributing pharmaceuticals, biotechnology products, medical devices, and other areas. Major activities include active ingredient development, generic and OTC drug manufacturing, formulation, bio-pharmaceutical development, and contract research. Key divisions are pharmaceuticals and biopharma, biotechnology, medical devices, and contract research organizations. Drug regulatory agencies are responsible for licensing, regulating, and monitoring life science industries and companies to ensure safety, efficacy, and quality.

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    LTR THUND 3

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    Life science comprises all scientific studies related to living organisms including plants, animals, and humans. It includes fields like biology, biochemistry, biotechnology, genetics, and other branches of science and technology related to biology. The life science industry includes organizations researching, developing, manufacturing, and distributing pharmaceuticals, biotechnology products, medical devices, and other areas. Major activities include active ingredient development, generic and OTC drug manufacturing, formulation, bio-pharmaceutical development, and contract research. Key divisions are pharmaceuticals and biopharma, biotechnology, medical devices, and contract research organizations. Drug regulatory agencies are responsible for licensing, regulating, and monitoring life science industries and companies to ensure safety, efficacy, and quality.

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    © All Rights Reserved
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    8 views2 pages

    LTR Thund 3

    Uploaded by

    laluroshan123
    Life science comprises all scientific studies related to living organisms including plants, animals, and humans. It includes fields like biology, biochemistry, biotechnology, genetics, and other branches of science and technology related to biology. The life science industry includes organizations researching, developing, manufacturing, and distributing pharmaceuticals, biotechnology products, medical devices, and other areas. Major activities include active ingredient development, generic and OTC drug manufacturing, formulation, bio-pharmaceutical development, and contract research. Key divisions are pharmaceuticals and biopharma, biotechnology, medical devices, and contract research organizations. Drug regulatory agencies are responsible for licensing, regulating, and monitoring life science industries and companies to ensure safety, efficacy, and quality.

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    LIFE SCIENCELife science comprisers of all scientific studies of life include plans animals and

    humans. It include Biology biochemistry biotechnology Genetics and all other branches of Science
    and Technology related to biology LIFE SCIENCE INDUSTRY:Lfe science industry to force to
    all organisations and companies who research on living thingsLIFE SCIENCE INDUSTRY:Licence
    industry comprises Research Development and manufacturing of Pharmaceuticals,biotechnology
    based food and medicines, medical devices,biomedical Technology,cosmetics,food processing,
    contract Research Organisation etc. PHARMA Pharmaceuticals (medicinal
    products,therapeutics,profiletics vaccines etc companies are collectively called as
    Pharma.BIOPHARMA. Pharmaceuticals with active agents biological in nature and manufactured
    using biotechnology are called biopharma. MAJOR ACTIVITIES OF PHARMA AND
    BIOPHARMA.: a)Active ingredient development and manufacturing b) generic drugs OTC drugs
    manufacture and distribution c) formulation/ contract formulation d) bio Pharmaceutical development
    /manufacturing BIOTECHNOLOGY. Natural process of living organisms are used to manufacture
    products, food and medicinal products.eg. Of product sugar bread BT brinjal and anti biotic etc
    MAJOR DIVISIONS OF LIFE SCIENCE INDUSTRY: a. Pharma and biofarma b. Biotechnology
    c. Medical devices d. Contract Research Organisation PHARMACEUTICALS COMPRISES OF
    FOUR : 1.Domestic formulation companies 2. Export oriented formulation companies 3. API
    manufacturers 4. Contract manufacturing of formulations.FORMULATION: Formulation is a multi
    step process where active drug is mixed with all other components to make a final medicinal product
    eg. Tablet, capsule etc Duties Of Drug Regulatory Agency They are government authorities
    responsible for licensing regulating and monitoring of life science industries and companies price
    to people

    Drug Regulatory Agency In India: 1. Central drug standard control organisation (CDSCO) 2.National
    Pharmaceutical pricing authority(NPPA) THE FUNCTION OF CDSCO: It ensure the safety
    efficiency and quality of drugs cosmetics diagnosis and devices in the country TWO DRUG
    REGULATORY ACTS OF INDIA: ?medicine and cosmetic act of 1940 and rules 1945?the pharmacy
    act of 1948?the drugs and magic remedies act of 1954?drug prices control order( dpco )1995
    CLINICAL TRIALS A type of research studies performed in people to find out if a new treatment
    like a new drug or diet or medical device is safe and effective in people. FOUR PHASES OF
    CLINICAL TRIALS a) Phase 1- test new drugs for the first time in a small group of people b)
    Phase 2- test treatments that have been found to be safe in Phase 1 done in a large human group
    c)Phase 3- conducted on large populations and different regions and countries d)phase 4- done after
    approval for further testing in wide populations over longer time FUNCTIONS OF KSPC It is
    a body functioning under Kerala State Health Department. It is constituted under section 19 of
    Pharmacy act 1948. It regulate the professional practice of Pharmacy in Kerala PHARMACOPOEIA:
    Is a book containing a list of drugs, their formulas, and methods for making medicinal
    preparations,requirements and test for the strength and purity, and other related information. The
    description of preparation is called monographs

    PHARMACY:The art practice or profession of preparing processing compounding and dispensing


    medicinal drugs. Pharmacy is derived from Greek word pharmkon name of a
    drug.PHARMACEUTICALS.:A pharmaceutical is any kind of drug used for the medicinal purpose
    to prevent diagnose treat and cure disease.PHARMA: A company that makes and sells
    Pharmaceuticals.PHARMACEUTICAL EXCIPIENTS:An excipient is pharmacological inactive
    substance formulated along with active ingredients.Example filler diluvent wetting agent solvent
    etc.SCHEDULES OF DRUG:Schedules are set of provisions for classification of drugs forms
    standard requirements and regulations related to drug and cosmetic act 1940 and rules 1945
    IMPORTANT SCHEDULES OF DRUGS AND COSMETIC ACT. 1. Schedule D. Dealing with
    exception in drug imports 2.Schedule M. Deals with good manufacturing practices. Premises plants
    etc. 3.Schedule y. Guidelines for clinical trials import and manufacture of new drugs GLP: It is
    a quality system of controls research labs organisations to ensure uniformity, quality, reliability,
    of products used for human or animal health. TOPIC INVOLVED IN GLP 1.audit and inspection
    2.standard operating procedure 3.data recording 4.correct use of equipment 5.test items.6.staff.
    7.correct training 8.environment PARTS OF PHARMACOPOEIA: General notice?General
    chapters?General monographs ?Specific monograph

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