Chapter 11 - Manufacturing Operations
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?
- 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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