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
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.
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.
Producing and capacity planning
External distribution logistics
Post FDA approval
Post FDA approval
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
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
Standard Operating Procedures
Statement of Purpose
Safe Operating Procedures
Scope of Practice
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
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.
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.
Small scale manufacturing process facility
Large scale manufacturing facility
Part of a current manufacturing facility
Prior to IND application
During preclinical testing
During Phase I and II clinical testing
Prior to Phase III testing
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.
COGS vs product price
Phase III trial results
Projected market demand
Desired level of market saturation
In discrete components then assembled at the end
All together at once
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
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.
SOPs and master batch records
GMPs and SOPs
Results from 3 consecutive manufacturing process runs demonstrating processes filed in the NDA
Quality control analysis