Food and Drugs Authority Ghana
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Questions and Answers

What is the Food and Drugs Authority's vision?

  • To conduct clinical trials in the country
  • To create and sustain a Regulatory Centre of Excellence on the African Continent (correct)
  • To ensure the safety of food and drugs
  • To regulate the sale of tobacco products

    • What is the primary mission of the FDA?

  • To conduct inspections of medical devices
  • To ensure the quality of household chemical substances
  • To regulate the sale of cosmetics
  • To protect public health by assuring the safety, efficacy and security of human and veterinary drugs (correct)

    • What is the FDA's quality policy?

  • To continually ensure quality, safe and efficacious products through Registration, Inspections, Licensing, Surveillance and Clinical Trials activities (correct)
  • To conduct clinical trials in the country
  • To ensure the safety of food and drugs
  • To regulate the sale of tobacco products

    • What is the FDA's mandate?

    <p>To regulate food, drugs, food supplements, herbal and homeopathic medicines, veterinary medicines, cosmetics, medical devices, household chemical substances, tobacco and tobacco products and the conduct of clinical trials protocols</p> Signup and view all the answers

    When was the FDA established?

    <p>1992</p> Signup and view all the answers

    What is the legal basis of the FDA's mandate?

    <p>Public Health Act, 2012 Act 851</p> Signup and view all the answers

    What is the responsibility of the FDA's Governing Board?

    <p>To ensure the effective implementation of the functions of the Authority</p> Signup and view all the answers

    How many members are on the FDA's Governing Board?

    <p>11</p> Signup and view all the answers

    What is the orientation of solubilisate within the micelle?

    <p>Preferred orientations depending on solubilisate nature</p> Signup and view all the answers

    Where can solubilisate be located within the micelle?

    <p>Between hydrophilic head groups and in the palisade layer</p> Signup and view all the answers

    What is the characteristic of the micelle interior?

    <p>Liquid-like</p> Signup and view all the answers

    What is the difference between solubilisation and emulsification?

    <p>Oil-phase concentration is lower in solubilisation</p> Signup and view all the answers

    What happens during storage of emulsification products?

    <p>Sedimentation/creaming occurs</p> Signup and view all the answers

    What is the characteristic of solubilisation end-products?

    <p>Transparent or translucent</p> Signup and view all the answers

    What is the primary reason for surfactant monomers to self-assemble in the bulk of the surfactant solution?

    <p>To avoid overcrowding of the interface</p> Signup and view all the answers

    What is the term used to describe the concentration at which micelles begin to form?

    <p>Critical micelle concentration</p> Signup and view all the answers

    What is the result of surfactant accumulation at the surface or interface?

    <p>A decrease in 𝛾</p> Signup and view all the answers

    What is the composition of the core of anionic micelles?

    <p>Hydrocarbon core</p> Signup and view all the answers

    What is the term used to describe the process of surfactant monomers forming aggregates in the bulk of the surfactant solution?

    <p>Micellisation</p> Signup and view all the answers

    What is the characteristic of the head groups of anionic micelles?

    <p>Ionic</p> Signup and view all the answers

    What is the layer that is adjacent to the Stern Layer?

    <p>Guoy-Chapman Layer</p> Signup and view all the answers

    What is the driving force behind the formation of micelles?

    <p>Hydrophobic interactions</p> Signup and view all the answers

    What is the primary factor that affects the solubility of a crystalline solid in a micelle?

    <p>Latent heat of fusion</p> Signup and view all the answers

    What happens to the CMC of an ionic micelle when an electrolyte is added?

    <p>It decreases</p> Signup and view all the answers

    Which type of surfactant is a better solubilising agent in very dilute solutions?

    <p>Non-ionic surfactant</p> Signup and view all the answers

    What happens to the extent of solubilisation of a polar solubilisate in an ionic micelle when the temperature is increased?

    <p>It increases</p> Signup and view all the answers

    What is the effect of increasing the size of a micelle on the amount of material solubilised?

    <p>It increases</p> Signup and view all the answers

    What is the primary factor that affects the solubility of a non-polar solubilisate in a micelle?

    <p>Size of the micelle</p> Signup and view all the answers

    What happens to the aggregation number of an ionic micelle when an electrolyte is added?

    <p>It increases</p> Signup and view all the answers

    What is the effect of increased thermal agitation on the solubility of a solubilisate in a micelle?

    <p>It increases</p> Signup and view all the answers

    Study Notes

    Food and Drugs Authority Ghana (FDA Ghana)

    • Vision: To create and sustain a Regulatory Centre of Excellence on the African Continent.

    Mission

    • Protect public health by assuring the safety, efficacy, and security of:
      • Human and veterinary drugs
      • Food
      • Biological products
      • Cosmetics
      • Medical devices
      • Household chemical substances
      • Tobacco
      • Conduct of clinical trials in the country

    Quality Policy

    • Ensure quality, safe, and efficacious/ effective/ wholesome products through:
      • Registration
      • Inspections
      • Licensing
      • Surveillance
      • Clinical Trials activities
    • Conformity with national and international standards to meet customer satisfaction

    Mandate

    • National Regulatory Body responsible for the regulation of:
      • Food
      • Drugs
      • Food supplements
      • Herbal and homeopathic medicines
      • Veterinary medicines
      • Cosmetics
      • Medical devices
      • Household chemical substances
      • Tobacco and tobacco products
      • Conduct of clinical trials protocols

    History

    • Established in 1992 as the Food and Drugs Board (FDB) based on the 1992 Food and Drug Law (PNDCL 305B)
    • Renamed to Food and Drugs Authority in 2012 after the Food and Drugs Act of 1996 and Public Health Act 581, 2012

    Governance

    • Legal mandate found in Part 6 (Tobacco Control Measures), Part 7 (organisation and responsibilities of the FDA), and Part 8 (Clinical trials) of the Public Health Act, 2012 Act 851
    • Eleven-member Governing Board responsible for ensuring effective implementation of the Authority's functions
    • Administered by the Chief Executive Officer, who reports to the Governing Board and oversees daily operational management, service delivery, and strategic issues.

    Micellisation

    • The number of surfactant monomers increases at the interface until a concentration is reached where they self-assemble in the bulk of the surfactant solution to form aggregates called micelles.
    • Micelles are formed as an alternative to overcrowding of the interface.
    • The concentration at which micelles begin to form is the critical micelle concentration (CMC).

    Types of Micelles

    • Non-ionic micelle
    • Anionic micelle
    • Cationic micelle

    Structure of Micelles

    • Micelles have a hydrocarbon core and a Stern layer with ionic head groups.
    • Guoy-Chapman layer is present at the surface of the micelle.

    Solubilisation

    • Micelles are dynamic species with liquid-like interiors.
    • Certain orientations and locations within the micelle may be greatly preferred depending on the nature of the solubilisate.
    • Solubilisates can be located in different parts of the micelle, including:
      • The surface of the micelle
      • Between the hydrophilic head groups
      • Palisade layer
      • Deeper in the palisade layer
      • Micelle core

    Factors Affecting Solubilisation

    • Surfactant:
      • Size of micelle affects solubilisation, with larger micelles generally solubilising more material.
      • CMC affects solubilisation, with non-ionic surfactants being better solubilising agents than ionics in very dilute solutions.
    • Solubilisate:
      • Crystalline solids have less solubility in micelles than liquids of similar structure.
    • Electrolyte:
      • Addition of electrolyte to ionic micelles decreases CMC and increases aggregation number, leading to increased solubilisation.
    • Temperature:
      • Increased temperature for ionic surfactants increases the extent of solubilisation for both polar and nonpolar solubilisates.
      • Increased thermal agitation generally increases the space available for solubilisation in the micelle.

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    Description

    This quiz covers the vision, mission, and quality objectives of the Food and Drugs Authority in Ghana, responsible for ensuring public health and safety.

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