Chapter 11 - Manufacturing Operations

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  • 1/43 Questions

    True or false:  QC testing is considered a part of the manufacturing process and the QC results are reviewed by QA.

    • True
    • False
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About This Quiz

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?

Operations Quizzes & Trivia

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  • 2. 

    True or False: Outsourcing is very common for smaller pharma and biotech companies.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    Outsourcing is indeed very common for smaller pharma and biotech companies. These companies often lack the resources and capabilities to handle all aspects of drug development and manufacturing in-house. By outsourcing certain tasks such as clinical trials, manufacturing, or regulatory affairs, these companies can access specialized expertise and facilities without the need for significant investment. This allows them to focus on their core competencies and bring their products to market more efficiently.

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  • 3. 

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

    • True

    • False

    Correct Answer
    A. True
    Explanation
    The API manufacturing process is usually patented because pharmaceutical companies invest significant resources in research and development to create new drugs. Patents provide legal protection and exclusivity for a certain period of time, allowing companies to recoup their investments and have a competitive advantage in the market. By patenting the manufacturing process, companies can prevent others from replicating their methods and producing the same API, ensuring their intellectual property rights are protected. This encourages innovation and incentivizes companies to continue developing new drugs.

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  • 4. 

    For what does SOP stand?

    • Standard Operating Procedures

    • Statement of Purpose

    • Safe Operating Procedures

    • Scope of Practice

    Correct Answer
    A. Standard Operating Procedures
    Explanation
    SOP stands for Standard Operating Procedures. Standard Operating Procedures are a set of step-by-step instructions that outline how to carry out a specific task or process in a consistent and efficient manner. These procedures are established to ensure that all employees follow the same guidelines and protocols, promoting uniformity and quality in the organization's operations. Standard Operating Procedures are commonly used in various industries to enhance productivity, reduce errors, and maintain safety standards.

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  • 5. 

    True or false: When a product is to be distributed globally, the foundation headquarters for the company is where the call centers are maintained, decisions are made regarding how much product will be maintained, and the type of packaging changes needed to comply with local regulations.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    The statement is true because when a product is distributed globally, it is necessary for the foundation headquarters of the company to be responsible for maintaining call centers, making decisions about product quantity, and ensuring packaging compliance with local regulations. The foundation headquarters serves as the central hub for coordinating and overseeing these aspects of global distribution to ensure consistency and efficiency across different markets.

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  • 6. 

    True or false: Planned primary packaging must be described in an NDA.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    Planned primary packaging must be described in an NDA because primary packaging refers to the immediate container or wrapper of a product, and it plays a crucial role in protecting the product from contamination, tampering, and degradation. Therefore, it is essential to disclose the details of the planned primary packaging in an NDA to ensure that the packaging meets the necessary standards and requirements for the product's safety and efficacy.

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  • 7. 

    How are drugs created?

    • In discrete components then assembled at the end

    • All together at once

    Correct Answer
    A. In discrete components then assembled at the end
    Explanation
    Drugs are typically created through a process that involves assembling discrete components at the end. This means that various individual components or ingredients are synthesized separately and then combined in a specific manner to create the final drug product. This approach allows for greater control over the manufacturing process and ensures the desired properties and effectiveness of the drug. By assembling the components at the end, it also allows for adjustments and modifications to be made if necessary.

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  • 8. 

    Which of the following play a role in manufacturing facility placement?

    • Demand forecasts

    • Tax considerations

    • Cost considerations

    • B and C only

    • A,B,C

    Correct Answer
    A. A,B,C
    Explanation
    Demand forecasts, tax considerations, and cost considerations all play a role in manufacturing facility placement. Demand forecasts help determine the location that can best serve the target market. Tax considerations help in selecting a location with favorable tax policies and incentives. Cost considerations help in evaluating the overall expenses associated with the facility, such as labor costs, transportation costs, and utility costs. Therefore, all three factors are important in deciding the placement of a manufacturing facility.

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  • 9. 

    What are GMP's?

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

    • 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

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

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

    Correct Answer
    A. Good Manufacturing Processes, regulations that describe the manufacturing systems required to produce safe and effective products
    Explanation
    GMP's refer to Good Manufacturing Processes, which are regulations that describe the manufacturing systems required to produce safe and effective products. These processes ensure that products are manufactured in a consistent and controlled manner, following quality standards and guidelines. GMP's are essential in industries such as pharmaceuticals, food and beverages, and cosmetics to ensure the safety and efficacy of the products being produced.

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  • 10. 

    For what is Manufacturing Operations responsible?

    • Producing a product to be distributed to clinical trial subjects

    • Producing a product for mass distribution

    • Labelling, packaging, and storage of drugs

    • A and B

    • A,B,C

    Correct Answer
    A. A,B,C
    Explanation
    Manufacturing Operations is responsible for producing a product to be distributed to clinical trial subjects, producing a product for mass distribution, and also for the labeling, packaging, and storage of drugs. This means that Manufacturing Operations is involved in the entire process of manufacturing and preparing drugs for distribution, both for clinical trials and for mass distribution.

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  • 11. 

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

    • True

    • False

    Correct Answer
    A. False
    Explanation
    The drug product manufacturing process is not usually patented. While the drug itself may be patented, the manufacturing process is typically not. This is because the manufacturing process is considered a trade secret and disclosing it through a patent would make it available to the public. Pharmaceutical companies often rely on trade secret protection to maintain the confidentiality and competitive advantage of their manufacturing processes. Therefore, the statement that the drug product manufacturing process is usually patented is false.

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  • 12. 

    What does QC do?

    • Focuses on the integrity of of processes and overseeing manufacturing

    • Tests and evaluates the manufactured product to ensure safety/effectiveness

    • Controls the manufacturing facility

    • Makes sure the manufacturing processes adhere to the stringent FDA regulations/manufacturing levels

    Correct Answer
    A. Tests and evaluates the manufactured product to ensure safety/effectiveness
    Explanation
    QC, or Quality Control, is responsible for testing and evaluating the manufactured product to ensure its safety and effectiveness. This involves conducting various tests and inspections to verify that the product meets the required standards and specifications. By doing so, QC plays a crucial role in identifying any defects or issues with the product and ensuring that it meets the necessary quality criteria before it is released to the market. This helps to maintain the integrity of the processes and ensures that the final product is of high quality and safe for consumers to use.

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  • 13. 

    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.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    False. The correct answer is false because Manufacturing Operations is responsible for the production of the active ingredient, not Development/Commercial Operations. Development/Commercial Operations is responsible for package labeling and distribution of the drug.

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  • 14. 

    What is an SOP?

    • 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.

    • 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

    • The act of delivering or distributing the new drug product

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

    Correct Answer
    A. Official, detailed, written instructions for the management of clinical trials or drug formation manufacturing.
    Explanation
    An SOP refers to official, detailed, written instructions for the management of clinical trials or drug formation manufacturing. These instructions outline the specific procedures and processes that need to be followed to ensure the proper conduct of clinical trials or the manufacturing of drugs. SOPs are crucial in maintaining consistency, quality, and compliance with regulations in these industries. They provide a standardized approach and serve as a reference guide for all personnel involved in these activities.

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  • 15. 

    True or false: API manufacturing and drug product manufacturing are housed at the same manufacturing facility

    • True

    • False

    Correct Answer
    A. False
    Explanation
    API manufacturing and drug product manufacturing are not housed at the same manufacturing facility. These two processes are typically carried out in separate facilities due to the different requirements and regulations involved. API manufacturing involves the production of active pharmaceutical ingredients, while drug product manufacturing involves the formulation and packaging of the final drug product. Keeping these processes separate ensures proper quality control, adherence to regulatory standards, and reduces the risk of contamination or cross-contamination. Therefore, the correct answer is false.

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  • 16. 

    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?

    • Description of the process for producing the API

    • Description of the process for manufacturing the drug product

    • Description of the proposed manufacturing facility for the drug product

    • Full analytical analysis of the API characterization and test methods

    Correct Answer
    A. Description of the proposed manufacturing facility for the drug product
    Explanation
    The description of the proposed manufacturing facility for the drug product is not a necessary component of the IND. While it is important to have a description of the process for producing the API, the process for manufacturing the drug product, and a full analytical analysis of the API characterization and test methods, the specific details of the manufacturing facility are not required in the IND application.

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  • 17. 

    The first type of manufacturing facility is the

    • Pilot facility

    • Small scale manufacturing process facility

    • Large scale manufacturing facility

    • Part of a current manufacturing facility

    Correct Answer
    A. Small scale manufacturing process facility
    Explanation
    A small scale manufacturing process facility refers to a manufacturing facility that is designed for producing goods on a smaller scale compared to large scale manufacturing facilities. These facilities are typically used for testing and developing new products, conducting research, or producing limited quantities of products. They are often used by startups or companies that specialize in niche markets. Unlike large scale facilities, small scale manufacturing process facilities have lower production capacities and are more flexible in terms of adapting to changes in product design or production processes.

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  • 18. 

    At what point does the FDA allow a facility to manufacture a new product?

    • After the drug is approved

    • After the FDA conducts a pre-approval investigation

    • After the results from the phase III trials are analyzed

    • Once the facility is up and running

    Correct Answer
    A. After the FDA conducts a pre-approval investigation
    Explanation
    The FDA allows a facility to manufacture a new product after conducting a pre-approval investigation. This investigation is conducted by the FDA to ensure that the facility meets all the necessary standards and regulations for manufacturing the product. It includes a thorough review of the facility's processes, equipment, and personnel to ensure compliance with FDA guidelines. Once the FDA is satisfied with the results of the investigation, the facility is given permission to manufacture the new product.

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  • 19. 

    True or false:  Each production batch must be tested by QA and approved by QC before being sold.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    The statement is false because not every production batch needs to be tested by QA and approved by QC before being sold. While it is important to have quality control measures in place, not every batch requires testing and approval. Some batches may have been previously tested and approved, or they may have met the necessary quality standards during the production process. The decision on whether or not to test and approve a batch before sale depends on various factors, such as the product's history, quality control procedures, and regulatory requirements.

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  • 20. 

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

    • True

    • False

    Correct Answer
    A. False
    Explanation
    Niche products do not face a different set of manufacturing hurdles than blockbuster products do. Both types of products may encounter similar challenges in terms of production, such as ensuring quality control, meeting production deadlines, and managing supply chains. While the scale of manufacturing may differ between niche and blockbuster products, the fundamental manufacturing hurdles remain the same. Therefore, the statement that niche products face a different set of manufacturing hurdles than blockbuster products is false.

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  • 21. 

    Match the type of manufacturing process change with its description:1. Minor changes2. Moderate changes3. Major changes

    • Require full FDA review require FDA notification but no formal review do not require immediate FDA review; are reported in annual report filed with FDA

    • Do not require immediate FDA review; are reported in annual report filed with FDA require FDA notification but no formal review Require full FDA review

    • Require FDA notification but no formal review do not require immediate FDA review; are reported in annual report filed with FDA Require full FDA review

    Correct Answer
    A. Do not require immediate FDA review; are reported in annual report filed with FDA require FDA notification but no formal review Require full FDA review
    Explanation
    The correct answer matches the type of manufacturing process change "Minor changes" with the description "do not require immediate FDA review; are reported in annual report filed with FDA," matches the type of manufacturing process change "Moderate changes" with the description "require FDA notification but no formal review," and matches the type of manufacturing process change "Major changes" with the description "Require full FDA review."

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  • 22. 

    What happens when a company fails to comply with the process change protocol?

    • Consent decree for marketed product

    • Non-approvable letter for an NDA

    • A warning letter

    • All of the above

    • B and c only

    Correct Answer
    A. All of the above
    Explanation
    When a company fails to comply with the process change protocol, they may face various consequences. One possible outcome is receiving a consent decree for a marketed product, which is a legal agreement that outlines the actions the company must take to rectify the non-compliance. Another consequence could be receiving a non-approvable letter for a New Drug Application (NDA), indicating that the company's proposed changes to the drug manufacturing process are not acceptable. Additionally, the company may also receive a warning letter, which notifies them of the violation and requests corrective actions. Therefore, the correct answer is "all of the above" as all these consequences can occur when compliance with the process change protocol is not met.

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  • 23. 

    What documentation is required for the FDA to validate a manufacturing facility?

    • SOPs and master batch records

    • GMPs and SOPs

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

    • Quality control analysis

    Correct Answer
    A. Results from 3 consecutive manufacturing process runs demonstrating processes filed in the NDA
    Explanation
    To validate a manufacturing facility, the FDA requires results from 3 consecutive manufacturing process runs demonstrating processes filed in the NDA. This means that the facility needs to provide evidence of consistently following the processes outlined in the New Drug Application (NDA) for a particular product. By demonstrating successful manufacturing runs over a period of time, the facility can prove that it meets the FDA's standards for quality and consistency. This requirement ensures that the facility is capable of producing safe and effective drugs.

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  • 24. 

    At which stage in the product life cycle are manufacturing processes first designed?

    • Preclinical development

    • Phase I

    • Phase II

    • Phase III

    • Post FDA approval

    Correct Answer
    A. Preclinical development
    Explanation
    During the preclinical development stage, manufacturing processes are first designed. This stage involves conducting laboratory and animal testing to assess the safety and efficacy of the product. It is during this stage that the manufacturing processes are planned and developed to ensure that the product can be produced efficiently and consistently once it enters clinical trials and eventually reaches the market.

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  • 25. 

    Manufacturing operations ends with product packaging.  Which of the following is NOT included in the purposes that packaging serves?

    • Protecting the product

    • Identifying the product in the eyes of customers

    • Assuring the product maintains efficacy during its shelf life.

    • Tracking the product

    • Labeling the product in accordance with FDA standards

    Correct Answer
    A. Assuring the product maintains efficacy during its shelf life.
    Explanation
    Packaging serves several purposes in manufacturing operations, including protecting the product, identifying the product in the eyes of customers, tracking the product, and labeling the product in accordance with FDA standards. However, assuring the product maintains efficacy during its shelf life is not included in the purposes of packaging. This is because maintaining product efficacy typically falls under the responsibility of quality control and proper storage conditions, rather than packaging itself. Packaging may contribute to maintaining product efficacy indirectly by providing protection and preserving the product's integrity, but it is not the primary purpose of packaging.

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  • 26. 

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

    • 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.

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

    • 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.

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

    Correct Answer
    A. Stringent oversight is more effective and enforceable in a smaller number of locations
    Explanation
    Having a smaller number of manufacturing facilities allows for better oversight and enforcement of regulations and quality control measures. With fewer locations to monitor, it becomes easier for companies to ensure compliance and maintain consistent standards across their operations. This can help prevent issues such as manufacturing interruptions and product shortages, as well as improve overall efficiency and productivity. Additionally, centralized oversight can also lead to cost savings by reducing the need for duplicate resources and personnel at multiple facilities.

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  • 27. 

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

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

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

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

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

    Correct Answer
    A. Cost of production with relation to projected revenue is critical to evaluating commercial feasibility of a product
    Explanation
    Manufacturing Operations needs to be kept abreast of accounting information, such as the Cost of Goods Sold, because the cost of production in relation to projected revenue is critical in determining the commercial feasibility of a product. By understanding the cost of production and comparing it to the expected revenue, Manufacturing Operations can assess whether the product will be profitable and make informed decisions about production and resource allocation. This information is essential for effective planning, budgeting, and decision-making within the department.

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  • 28. 

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

    • Prior to IND application

    • During preclinical testing

    • During Phase I and II clinical testing

    • Prior to Phase III testing

    Correct Answer
    A. Prior to Phase III testing
    Explanation
    The refinements to the API manufacturing process are completed prior to Phase III testing. This suggests that the API manufacturing process undergoes improvements and adjustments before the product reaches the final stage of clinical testing. This is crucial as it allows for any necessary modifications to be made to ensure the quality and effectiveness of the API before moving forward with Phase III testing.

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  • 29. 

    True or false: Secondary packaging activities during commercial manufacturing are typically handled by a contract research organization.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    Secondary packaging activities during commercial manufacturing are typically not handled by a contract research organization. These activities, such as labeling, packaging, and assembling finished products into larger units, are usually carried out by the manufacturing company or a third-party packaging company. Contract research organizations primarily focus on research and development activities, rather than packaging and manufacturing processes. Therefore, the correct answer is false.

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  • 30. 

    When might a company partner with local contract manufacturing facilities in an international setting?

    • To save time by using current facilities rather than going thought the hurdles of building an international facility

    • To save money by allocating funds to other areas than building a new facility

    • If the demand in that country is higher than the level of company owned facility capacity

    • To promote a good opinion of the company in the new country's mind.

    • To help the non-US country's economy in which it is operating

    Correct Answer
    A. If the demand in that country is higher than the level of company owned facility capacity
    Explanation
    A company might partner with local contract manufacturing facilities in an international setting if the demand in that country exceeds the capacity of the company's own facility. This allows the company to meet the increased demand without having to invest in building a new facility or expanding their existing one. By partnering with local facilities, the company can save time and money, as they can utilize the current facilities instead of going through the challenges of constructing an international facility. Additionally, this partnership can help support the economy of the non-US country in which the company is operating.

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  • 31. 

    For what is supply chain management responsible?

    • Planning for and coordinating the network of company facilities.

    • Enforcing strict regulatory procedures at the manufacturing facilities.

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

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

    Correct Answer
    A. Planning for and coordinating the network of company facilities.
    Explanation
    Supply chain management is responsible for planning and coordinating the network of company facilities. This involves ensuring that all facilities, such as manufacturing plants, warehouses, and distribution centers, are strategically located and efficiently organized to meet the demand for products. It also includes coordinating the flow of materials, information, and finances between these facilities to optimize the overall supply chain performance. By effectively managing the network of facilities, supply chain management plays a crucial role in improving operational efficiencies, reducing costs, and enhancing customer satisfaction.

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  • 32. 

    Scale-up for commercial manufacturing is based on what?

    • COGS vs product price

    • Phase III trial results

    • Projected market demand

    • Desired level of market saturation

    Correct Answer
    A. Projected market demand
    Explanation
    The scale-up for commercial manufacturing is based on projected market demand. This means that the decision to increase production is determined by the estimated demand for the product in the market. If there is a high projected demand, it makes sense to scale up production to meet the needs of the market. Conversely, if the projected demand is low, scaling up may not be necessary or may even be detrimental to the business. Therefore, projected market demand is a key factor in determining the scale-up for commercial manufacturing.

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  • 33. 

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

    • Business forecasting

    • Producing and capacity planning

    • Supply procurement

    • External distribution logistics

    Correct Answer
    A. External distribution logistics
    Explanation
    Supply chain management is responsible for various aspects of the supply chain, including business forecasting, producing and capacity planning, and supply procurement. However, external distribution logistics is not a responsibility of supply chain management. External distribution logistics typically involves the transportation and delivery of finished goods to customers, which is usually handled by a separate department or third-party logistics provider.

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  • 34. 

    When might a large pharma company opt to outsource manufacturing or packaging responsibilities?

    • Capacity constraints

    • To minimize outlays for capital and equipment and facilities

    • To avoid long time delays associated with building a new plant.

    • To preserve resources that would be required to build and maintain a particular manufacturing operation.

    • A and D

    Correct Answer
    A. A and D
    Explanation
    A large pharma company might opt to outsource manufacturing or packaging responsibilities in order to address capacity constraints and preserve resources that would be required to build and maintain a particular manufacturing operation. By outsourcing, they can avoid the need to invest in additional capital, equipment, and facilities, as well as the time delays associated with building a new plant. This allows them to focus their resources on other core activities and potentially increase their overall efficiency and competitiveness.

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  • 35. 

    Why are pilot plants separate from large scale commercial manufacturing plants?

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

    • They are not FDA approved for large scale batches.

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

    • They are not kept separate from large scale operations.

    Correct Answer
    A. They are not FDA approved for large scale batches.
    Explanation
    Pilot plants are separate from large scale commercial manufacturing plants because they are not FDA approved for large scale batches. This means that the drugs or products being tested in pilot plants have not yet been fully approved for mass production. Keeping pilot plants separate ensures that any issues or complications that may arise during the development or testing process do not affect the current manufacturing operations. By maintaining this separation, the pilot plants can continue to experiment and refine their processes without risking the quality or safety of the products being produced on a larger scale.

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  • 36. 

    What is a product stock-out?

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

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

    • When a company cannot produce enough product to satisfy the demand

    • A and B

    • B and C

    Correct Answer
    A. B and C
    Explanation
    A product stock-out refers to a situation where a company cannot produce enough product to satisfy the demand or keep up with the demand and loses sales to competitive products. This means that the company is unable to meet the market demand for its product, resulting in a shortage or unavailability of the product for consumers. This can lead to missed sales opportunities and potential loss of market share to competitors.

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  • 37. 

    Which is not a major responsibility of supply chain management?

    • To oversee the production of the actual drug components

    • To ensure adequate overall capacity through network planning and outsourcing

    • To establish overall performance targets

    • To manage procurement from suppliers of raw materials

    Correct Answer
    A. To oversee the production of the actual drug components
    Explanation
    The major responsibilities of supply chain management include ensuring adequate overall capacity through network planning and outsourcing, establishing overall performance targets, and managing procurement from suppliers of raw materials. However, overseeing the production of the actual drug components is not a major responsibility of supply chain management. This task is typically handled by the production or manufacturing department within the organization.

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  • 38. 

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

    • Preclinical development

    • Phase I

    • Phase II

    • Phase III

    • Post FDA approval

    Correct Answer
    A. Phase III
    Explanation
    In Phase III of the product life cycle, production of a drug is scaled up to commercial quantities. This is because Phase III is the final stage of clinical trials before seeking FDA approval. At this point, the drug has already undergone rigorous testing in large populations, and if it proves to be safe and effective, it moves forward for mass production to meet the demand in the market. Therefore, Phase III is the stage where production is scaled up to commercial quantities.

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  • 39. 

    What is a batch record?

    • A recipe for the entire drug product

    • Recipe for discrete parts of the manufacturing process.

    • A record of each batch that has been produced

    • None of the above

    Correct Answer
    A. Recipe for discrete parts of the manufacturing process.
    Explanation
    A batch record is a document that contains the recipe or instructions for the discrete parts of the manufacturing process. It provides detailed information on the materials, equipment, and procedures used in the production of a specific batch of a drug product. The batch record ensures consistency and traceability in the manufacturing process, allowing for quality control and regulatory compliance. It serves as a reference document for the production personnel, quality assurance, and regulatory authorities.

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  • 40. 

    Who is responsible for establishing global pricing contracts with suppliers?

    • Manufacturing Operations

    • Marketing

    • Managed Markets

    • Procurement

    • Supply Chain Management

    Correct Answer
    A. Procurement
    Explanation
    Procurement is responsible for establishing global pricing contracts with suppliers. This department is in charge of sourcing and purchasing goods and services for an organization. They negotiate with suppliers to secure the best prices and terms for the company. By establishing global pricing contracts, procurement ensures consistency and cost-effectiveness in the supply chain.

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  • 41. 

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

    • To save money

    • When the new drug product is administered via alternate delivery mechanisms

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

    • To increase production capacity.

    Correct Answer
    A. When the new drug product is administered via alternate delivery mechanisms
    Explanation
    A larger pharma company would partner with a drug delivery company to co-manufacture a new product when the new drug product is administered via alternate delivery mechanisms. This suggests that the drug delivery company has expertise or technology in delivering drugs through different methods than what the larger pharma company typically uses. By partnering with the drug delivery company, the larger pharma company can take advantage of their knowledge and capabilities to develop and manufacture the new product using these alternate delivery mechanisms. This partnership would allow the larger pharma company to expand their product offerings and potentially reach a wider market.

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  • 42. 

    What does QA do?

    • Focuses on the integrity of of processes and overseeing manufacturing

    • Tests and evaluates the manufactured product to ensure safety/effectiveness

    • Controls the manufacturing facility

    • Makes sure the manufacturing processes adhere to the stringent FDA regulations/manufacturing levels

    Correct Answer
    A. Focuses on the integrity of of processes and overseeing manufacturing
    Explanation
    The correct answer is "focuses on the integrity of processes and overseeing manufacturing." QA, or Quality Assurance, is responsible for ensuring that manufacturing processes are carried out correctly and that the products produced meet the required standards of safety and effectiveness. They oversee the entire manufacturing process to ensure that it adheres to strict regulations and quality control measures. Their main focus is on maintaining the integrity of processes and ensuring that the manufacturing operations run smoothly.

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  • 43. 

    What is the role of Manufacturing IT?

    • To troubleshoot manufacturing IT systems

    • To administer the global network for procurement, and process engineering

    • Manages large-scale information systems used for business transaction processes

    • B and C

    • A,B,C

    Correct Answer
    A. Manages large-scale information systems used for business transaction processes
    Explanation
    The role of Manufacturing IT is to manage large-scale information systems used for business transaction processes. This includes overseeing the implementation, maintenance, and optimization of IT systems that support various manufacturing operations such as procurement and process engineering. The Manufacturing IT team is responsible for ensuring the smooth functioning of these systems and troubleshooting any issues that may arise. Additionally, they may also be involved in administering the global network for procurement and process engineering.

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  • Mar 20, 2023
    Quiz Edited by
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  • Mar 23, 2009
    Quiz Created by
    Msquared
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