Chapter 11 - Manufacturing Operations

43 Questions | By Msquared | Last updated: Mar 20, 2022 | Total Attempts: 202

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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