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  • Welcome To The World of "Pharmaceutical Packaging"

    Caricato da

    Binu Skaria
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    The document discusses pharmaceutical packaging for exports. It notes that the global pharma market was worth $535 billion in 2005, with the largest markets being the USA, Europe, and Japan. Pharmaceutical packaging serves several important purposes, including route of administration, statutory compliance, pharmacopoeial standards, patent protection, dosage delivery, customer convenience, and product protection up to shelf life. Packaging requirements vary for regulated and generic markets and include items like a drug master file, material safety data sheets, and packaging identical to innovator products. The document outlines packaging-related documents needed for an abbreviated new drug application, including container/closure specifications and characterization data. It also discusses constraints in the Indian packaging industry and expectations for improvements.

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    The document discusses pharmaceutical packaging for exports. It notes that the global pharma market was worth $535 billion in 2005, with the largest markets being the USA, Europe, and Japan. Pharmaceutical packaging serves several important purposes, including route of administration, statutory compliance, pharmacopoeial standards, patent protection, dosage delivery, customer convenience, and product protection up to shelf life. Packaging requirements vary for regulated and generic markets and include items like a drug master file, material safety data sheets, and packaging identical to innovator products. The document outlines packaging-related documents needed for an abbreviated new drug application, including container/closure specifications and characterization data. It also discusses constraints in the Indian packaging industry and expectations for improvements.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Scarica in formato PDF, TXT o leggi online su Scribd
    Segnala contenuti inappropriati
    28 visualizzazioni16 pagine

    Welcome To The World of "Pharmaceutical Packaging"

    Caricato da

    Binu Skaria
    The document discusses pharmaceutical packaging for exports. It notes that the global pharma market was worth $535 billion in 2005, with the largest markets being the USA, Europe, and Japan. Pharmaceutical packaging serves several important purposes, including route of administration, statutory compliance, pharmacopoeial standards, patent protection, dosage delivery, customer convenience, and product protection up to shelf life. Packaging requirements vary for regulated and generic markets and include items like a drug master file, material safety data sheets, and packaging identical to innovator products. The document outlines packaging-related documents needed for an abbreviated new drug application, including container/closure specifications and characterization data. It also discusses constraints in the Indian packaging industry and expectations for improvements.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Scarica in formato PDF, TXT o leggi online su Scribd
    Segnala contenuti inappropriati
    di 16

    02.09.

    2006

    Welcome to the
    world of
    “Pharmaceutical
    Packaging”
    1
    Packaging for Pharma Exports
    Global Pharma market size 535 Billion USD in 2005

    Sale through Pharmacies in 2003-2004 in Billion USD

    USA Europe Japan Latam Others

    163.15 76.6 52.8 12.08 13.31

    Growth at the rate of 7.7%


    2
    Significance of Pharma packaging

    1. Route of administration
    2. Statutory compliance
    3. Pharmacopoeial standards
    4. Patent Protection
    5. Dosage delivery
    6. Customer convenience
    7. Product protection upto shelf life

    3
    Requirements

    ™Regulated markets and Nearly regulated markets


    ™Generics & Branded formulations
    ™DMF
    ™MSDS
    ™Identification
    ™Declaration from Vendors for compliance
    ™ Identical to Innovator product/pack

    4
    Drug Master File
    A Drug Master File (DMF) is a submission to the Food & Drug Admn. (FDA)
    that may be used to provide confidential detailed information about facilities,
    processes, packaging & storing of one or more human drugs.

    Types of DMF
    Type I : Manufacturing site, operating procedures & personnel
    Type II : Drug substance & drug substance intermediate
    Type III : Packaging material
    Type IV : Excipient, colourant, flavour & essence
    Type V : FDA accepted reference information

    Holder Obligation
    A. Notice reqd. for changes in DMF
    B. Listing of persons authorized to refer to a DMF
    C. Annual update

    5
    ANDA
    “Abbreviated New Drug Application”contains data for review & ultimate approval
    of a generic drug product. Once approved, an applicant may manufacture & market
    the generic drug product, provided all issues related to patent protection & exclusi-
    vity associated with the RLD (Reference Listed Drug) have been resolved in.

    *Generic drug applications are termed “abbreviated” as they are generally not reqd.
    to include preclinical (animal) & clinical (human) data to establish safety & effectiv-
    eness.

    Annual Updation
    Change in primary container
    Equivalency data
    1. Material characterization
    2. Stability data

    6
    Packaging Related Documents for ANDA
    For Container/Closure System

    ¾Container/Closure specification
    ¾Test reports & procedures (GTP’s & STP’s)
    ¾IR spectrums & DSC thermograms of std. & sample
    ¾Manufacturer’s test report (COA)
    ¾Dimensional drawing of container & closure
    ¾DMF authorization letter from manufacturers
    ¾DMF authorization letter from resin supplier
    ¾DMF authorization letter from colourant supplier
    ¾DMF authorization letter from liner supplier
    7
    Specification for HDPE bottle as per
    USP
    9Multiple internal reflectance

    9Thermal analysis

    9Light transmission

    9Non-volatile residue

    9Heavy metals

    9Container permeation
    8
    Specs. for Absorbent cotton (filler) as per
    EP
    9Identification
    9Acidity/Alkalinity
    9Foreign Fibers
    9Fluoresence
    9Neps
    9Absorbancy
    9Ether soluble substances
    9Extractable colouring matter
    9Surface active substances
    9Water soluble substances
    9Loss on drying
    9Sulphated ash
    9Weight per yard
    9
    Other requirements
    ™Resin grade

    ™Colourant grade

    ™Vendor name (DMF)

    ™Liner

    ™Innovator pack characterization for all primary


    pkg. materials
    10
    Patent Protection

    ƒPack outsert

    ƒUsage of oxygen absorbent

    ƒPack design

    ƒChild Resistant Closures

    11
    Labeling Requirements

    ™Country specific requirements


    ™Pharmacode
    ™Barcode
    ™Part peel labels
    ™NDC No.
    ™Blister pocket to have barcode, lot no. & expiry
    ™Braille script on carton

    12
    Constraints in Indian Pkg. Industry
    ‰ Few vendors with DMF

    ‰ GMP practices
    -Manufacturing
    -Documentation

    ‰ Quality Assurance
    ‰ Low investment in R&D

    13
    Implications
    ¾Importation of materials

    ¾Higher price

    ¾Transportation cost

    ¾Long lead time

    ¾High inventory

    ¾Less competitive in product pricing


    14
    Expectations

    ¾cGMP standards

    ¾Facility upgradation

    ¾Infrastructure

    ¾DMF approvals

    ¾Alliancing/partenering on key components

    15
    16

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