Chapter 11 - Manufacturing Operations

43 Questions | Total Attempts: 147

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Manufacturing Quizzes & Trivia

Why do you build me up, build me up, Buttercup Baby, just to let me down, let me down, and mess me around? . . . It's stuck in your head now, right?


Questions and Answers
  • 1. 
    For what is Manufacturing Operations responsible?
    • A. 

      Producing a product to be distributed to clinical trial subjects

    • B. 

      Producing a product for mass distribution

    • C. 

      Labelling, packaging, and storage of drugs

    • D. 

      A and B

    • E. 

      A,B,C

  • 2. 
    True or False: Niche products face a different set of manufacturing hurdles than blockbuster products do.
    • A. 

      True

    • B. 

      False

  • 3. 
    Given manufacturing interruptions and product shortages, why is there only a small number manufacturing facilities?
    • A. 

      Companies like to spread out their operations to increase national and international presence, so it may opt to put its manufacturing facility in a different location than R&D.

    • B. 

      Stringent oversight is more effective and enforceable in a smaller number of locations

    • C. 

      It is more cost effective to mass produce all products at one facility than have multiple facilities that are each responsible for a different product.

    • D. 

      Manufacturing facilities are expensive, so if a company doesn't have to build a new one, it wont.

  • 4. 
    For what is supply chain management responsible?
    • A. 

      Planning for and coordinating the network of company facilities.

    • B. 

      Enforcing strict regulatory procedures at the manufacturing facilities.

    • C. 

      Planning and coordinating the shipping logistics and disbursement of a product.

    • D. 

      Distribution of product to wholesalers who "buy direct" from pharma companies.

  • 5. 
    Supply chain managers must be adept at many things. Which of the following is the supply chain management not responsible?
    • A. 

      Business forecasting

    • B. 

      Producing and capacity planning

    • C. 

      Supply procurement

    • D. 

      External distribution logistics

  • 6. 
    True or false: Manufacturing Operations is responsible for package labeling and distribution of the drug and Development/Commercial Operations is responsible for the production of the active ingredient.
    • A. 

      True

    • B. 

      False

  • 7. 
    At which stage in the product life cycle are manufacturing processes first designed?
    • A. 

      Preclinical development

    • B. 

      Phase I

    • C. 

      Phase II

    • D. 

      Phase III

    • E. 

      Post FDA approval

  • 8. 
    At which point in the product life cycle is production of a drug scaled up to commercial quantities?
    • A. 

      Preclinical development

    • B. 

      Phase I

    • C. 

      Phase II

    • D. 

      Phase III

    • E. 

      Post FDA approval

  • 9. 
    Many documents go into the filing of an IND (Investigational New Drug) Application.  Which of the following is not a necessary component of the IND?
    • A. 

      Description of the process for producing the API

    • B. 

      Description of the process for manufacturing the drug product

    • C. 

      Description of the proposed manufacturing facility for the drug product

    • D. 

      Full analytical analysis of the API characterization and test methods

  • 10. 
    Why does Manufacturing Operations need to be kept abreast of accounting information, such as the Cost of Goods Sold?
    • A. 

      Financial information must be communicated to all departments to keep budgets in check

    • B. 

      Cost of production with relation to projected revenue is critical to evaluating commercial feasibility of a product

    • C. 

      Manufacturing Operations works closely with finance teams to information flows freely between the two groups

    • D. 

      Manufacturing Operations doesn't care about cost of goods sold; that's why there's the finance in place, to monitor costs and revenue

  • 11. 
    True or false: The API manufacturing process is usually patented.
    • A. 

      True

    • B. 

      False

  • 12. 
    True or false: The drug product manufacturing process is usually patented.
    • A. 

      True

    • B. 

      False

  • 13. 
    For what does SOP stand?
    • A. 

      Standard Operating Procedures

    • B. 

      Statement of Purpose

    • C. 

      Safe Operating Procedures

    • D. 

      Scope of Practice

  • 14. 
    What is a batch record?
    • A. 

      A recipe for the entire drug product

    • B. 

      Recipe for discrete parts of the manufacturing process.

    • C. 

      A record of each batch that has been produced

    • D. 

      None of the above

  • 15. 
    What is an SOP?
    • A. 

      A yardstick used to assess the capabilities of a company's new product in terms of current treatment, added benefits, level of toxicity, and product cost.

    • B. 

      A terminology used by licensing boards for various healthcare-related fields that defines the procedures, actions, and processes that are permitted for the new manufacturing facility

    • C. 

      The act of delivering or distributing the new drug product

    • D. 

      Official, detailed, written instructions for the management of clinical trials or drug formation manufacturing.

  • 16. 
    In what case would a larger pharma company partner with a drug delivery company to co-manufacture a new product?
    • A. 

      To save money

    • B. 

      When the new drug product is administered via alternate delivery mechanisms

    • C. 

      When the drug delivery company has new technology that will revolutionize the administration method of the product.

    • D. 

      To increase production capacity.

  • 17. 
    The first type of manufacturing facility is the
    • A. 

      Pilot facility

    • B. 

      Small scale manufacturing process facility

    • C. 

      Large scale manufacturing facility

    • D. 

      Part of a current manufacturing facility

  • 18. 
    At which state in the product life cycle are the refinements to the API manufacturing process completed?
    • A. 

      Prior to IND application

    • B. 

      During preclinical testing

    • C. 

      During Phase I and II clinical testing

    • D. 

      Prior to Phase III testing

  • 19. 
    Why are pilot plants separate from large scale commercial manufacturing plants?
    • A. 

      To keep the development/testing process from affecting the current manufacturing operations

    • B. 

      They are not FDA approved for large scale batches.

    • C. 

      To easily disassemble the plant if the drug product is not approved

    • D. 

      They are not kept separate from large scale operations.

  • 20. 
    True or false: API manufacturing and drug product manufacturing are housed at the same manufacturing facility
    • A. 

      True

    • B. 

      False

  • 21. 
    Scale-up for commercial manufacturing is based on what?
    • A. 

      COGS vs product price

    • B. 

      Phase III trial results

    • C. 

      Projected market demand

    • D. 

      Desired level of market saturation

  • 22. 
    How are drugs created?
    • A. 

      In discrete components then assembled at the end

    • B. 

      All together at once

  • 23. 
    What is a product stock-out?
    • A. 

      When a product hits the market and is fully stocked on the shelves

    • B. 

      When a pharma company cannot keep up with the demand and loses sales to competitive products

    • C. 

      When a company cannot produce enough product to satisfy the demand

    • D. 

      A and B

    • E. 

      B and C

  • 24. 
    What are GMP's?
    • A. 

      Good Manufacturing Processes, regulations that describe the manufacturing systems required to produce safe and effective products

    • B. 

      Guaranteed Minimum Pension (GMP) is the minimum pension which a United Kingdom occupational pension scheme has to provide for those employees who were contracted out of the State Earnings-Related Pension Scheme

    • C. 

      Gross Metropolitan Product is one of several measures of the size of the economy of a metropolitan area

    • D. 

      Greater Manchester Police is the Home Office police force responsible for policing the metropolitan county of Greater Manchester, in North West England.

  • 25. 
    What documentation is required for the FDA to validate a manufacturing facility?
    • A. 

      SOPs and master batch records

    • B. 

      GMPs and SOPs

    • C. 

      Results from 3 consecutive manufacturing process runs demonstrating processes filed in the NDA

    • D. 

      Quality control analysis

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