Pharmaceutical Company Departments
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Questions and Answers

What is considered when evaluating a Manufacturing Pharmacy Plant site?

  • Only the land space and parking requirements
  • Demographic, trade area, site economics, and competition factors (correct)
  • Only the total population of the surrounding area
  • Only the site's connectivity to road, rail, and water transport

    • What is the primary function of the Research & Development department?

  • Creating new products and innovations (correct)
  • Clinical studies and publications
  • Quality control and master batch records
  • Producing and accepting raw materials

    • What type of equipment is used to cleanse the air in a Manufacturing Pharmacy Plant?

  • Fibrous filters
  • HEPA filters (correct)
  • Ozone generators
  • Ultra Violet filters

    • In a Manufacturing Pharmacy Plant, what is the purpose of maintaining a certain temperature and humidity in the tableting area?

    <p>For acceptable quality product manufacturing</p> Signup and view all the answers

    What is the purpose of having separate sections for Antibiotics, biologicals, and cytotoxic materials in a Manufacturing Pharmacy Plant?

    <p>To reduce the risk of contamination and cross-contamination</p> Signup and view all the answers

    What happens when a door to a clean room is opened in a Manufacturing Pharmacy Plant?

    <p>Air flows outward from the clean room</p> Signup and view all the answers

    What is the primary purpose of stability testing in pharmaceutical products?

    <p>To assess the physical, chemical, biological, and microbiological characteristics of the product</p> Signup and view all the answers

    What is the recommended temperature range for storage under refrigeration, according to stability testing results?

    <p>Between 2 and 8 °C</p> Signup and view all the answers

    What is the purpose of assessing the content of products of decomposition in stability testing?

    <p>To identify potential degradation products that may affect product quality</p> Signup and view all the answers

    What is the term for the temperature range that does not exceed 40% of average relative humidity at controlled room temperature?

    <p>Dry place</p> Signup and view all the answers

    What is the purpose of dissolution tests in stability testing?

    <p>To demonstrate the efficacy of additives in the product</p> Signup and view all the answers

    What is the requirement for analytical methods used in stability testing?

    <p>They should be validated or verified, and the accuracy and precision recorded</p> Signup and view all the answers

    What is the primary purpose of enteric coating in tablet manufacturing?

    <p>To protect the tablet from the gastric environment</p> Signup and view all the answers

    What is the function of a surfactant in film-coating?

    <p>To enhance the spreadability of films</p> Signup and view all the answers

    What is the primary difference between a standard coating pan and a perforated coating pan?

    <p>The perforated pan is enclosed in a housing</p> Signup and view all the answers

    What is the purpose of the syruping/smoothing step in sugar-coating?

    <p>To apply a heavy layer of sugar</p> Signup and view all the answers

    What is the primary advantage of fluid bed coating over pan coating?

    <p>It produces a more uniform coating</p> Signup and view all the answers

    What is the function of a film former in film-coating?

    <p>To produce smooth and thin films</p> Signup and view all the answers

    What is the primary purpose of Current Good Manufacturing Practice regulations?

    <p>To define quality systems that ensure products are consistently produced and controlled to quality standards</p> Signup and view all the answers

    What does the 'Purity' aspect of PIQS ensure in a drug product?

    <p>The drug product contains only one substance without any impurities</p> Signup and view all the answers

    What is the result of non-compliance with CGMP guidelines?

    <p>License to manufacture drugs is not issued</p> Signup and view all the answers

    What is the purpose of quality control in drug manufacturing?

    <p>To ensure the quality of the final drug product</p> Signup and view all the answers

    What does the 'Identity' aspect of PIQS ensure in a drug product?

    <p>The drug product is the medicine that it claims to be</p> Signup and view all the answers

    What is the outcome of implementing Current Good Manufacturing Practice?

    <p>Improved quality of drug products</p> Signup and view all the answers

    What is the term for the uneven discoloration of a film?

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

    What is the process of fusing two gelatin surfaces together using a warm gelatin solution?

    <p>Heat welding</p> Signup and view all the answers

    What is the term for the dulling or fading of a film?

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

    What is the oldest method of manufacturing soft gelatin capsules?

    <p>Plate process</p> Signup and view all the answers

    What is the term for the detachment of a film from the tablet surface?

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

    What is the term for the rough, non-glossy surface of a tablet?

    <p>Orange Ped</p> Signup and view all the answers

    Study Notes

    Manufacturing Basics

    • CGMP (Current Good Manufacturing Practice) ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization
    • CGMP is part of QA (Quality Assurance) which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization
    • CGMP comprises of:
      • P: Purity - element containing one substance without any other drug tarnishing its existence
      • I: Identity - particular substance is the medicine that it claims to be
      • Q: Quality - manufacturing quality is conformance to specifications
      • S: Strength - testing methods and acceptable ranges for potency of the drug

    CGMP History

    • AO 43 s. 1999 and AO 153 s. 2004

    Manufacturing Plant/Facilities

    • Considerations for manufacturing pharmacy plant:
      • Demographic (total population, age composition, per capita income, educational level)
      • Trade area/traffic (geographical area to assess feasibility of continued clientele)
      • Site economics (estimate of potential passers-by/customers)
      • Competition (costs for establishment and operation)
    • Criteria for manufacturing pharmacy plant:
      • Connected with road, rail, and water transports
      • Sufficient supply of labor
      • Efficient sewage for disposal of water and wastes
      • Good and peaceful surroundings; safe
      • Sub-soil capable of bearing the load of the building, plant, and equipment
      • Sufficient land space requirements, also for parking of transport, and residential accommodation for staff and workers
      • Suitable climate (not humid)

    CGMP Organization

    • Departments involved:
      • Research & Development (innovation/new products, pilot)
      • Marketing Department (Advertisement/promotions)
      • Quality Control Department (Master Batch Records)
      • Production Department (produce, accept RM, personnel control)
      • Engineering Department (equipment)
      • Purchasing Department (procurement)
      • Medical Department (personnel, clinical trials)

    Stability Testing

    • Analytical methods: physical, chemical, biological, and microbiological test characteristics
    • Characteristics evaluated:
      • Assay value or potency
      • Content of products of decomposition
      • Physicochemical properties (hardness, disintegration, particulate matter)
    • Results of stability testing:
      • Storage conditions prominently indicated on the label
      • Storage temperatures: cold (2-8°C), refrigerator (no freezing), freezer (-5 to -20°C), deep freezer (-18°C)

    Manufacturing Process

    • Tablet manufacturing process:
      • Coating reasons: aesthetic appeal, enteric-coating, increase palatability, identification, modify release, protection, and stability
      • Coating equipment: standard coating pan, perforated coating pan, fluid bed coater
    • Capsule manufacturing process:
      • Hard gelatin capsules: pin method, preparation, compounding, filling, sealing, polishing/cleaning
      • Soft gelatin capsules: plate process, rotary die process, reciprocating die process, Accogel Capsule machine

    QC Tests

    • QC tests: determine the quality of the finished product
    • Types of defects in coating: mottling, sweating, bridging, erosion, cratering, blistering, blooming, blushing, twinning, orange peel

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    Quiz Team

    Description

    This quiz covers the various departments found in a pharmaceutical company, including Research and Development, Marketing, Quality Control, Production, Engineering, Purchasing, Medical, and Manufacturing. Learn about the roles and responsibilities of each department in the pharmaceutical industry. Test your knowledge of the different departments and their functions.

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