Show:
These Guys Mean Business
History Buffs
And by That, You Mean?
What's Up with all the Acronyms?
100
Legal consequences of not being compliant with cGMPs.
What are Fines/ Prison Terms/ Seizure and Quarantine of Product/ Close of Operations
100
Established in 1978, these practices identify the controls to assure manufacturers operate in a state of control, and create safe, pure, and effective products. (Hint: Provide the basis for FDA inspections)
What are Current Good Manufacturing Practices (cGMPs)
100
The quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular drug product.
What is Actual Yield
100
CFR (General and permanent rules published in the Federal Register by the departments and agencies of the Federal Government)
What is Code of Federal Regulations
200
The removal of already distributed products, their labeling, and/or promotional literature that violate the laws administered by the Food and Drug Administration (FDA). (hint: this may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority).
What is a Recall
200
Introduction of this act in 1938 was influenced by the more than 100 deaths due to Elixir Sulfanilamide, a highly toxic chemical analogue of antifreeze.
What is Food, Drug, and Cosmetic Act
200
The concentration of the drug substance, and/or how much active ingredient is present in each dosage, and/or the potency.
What is Strength
200
cGMPs
What are Current Good Manufacturing Practices
300
The most common cause of a 483 observation.
What is Failure to Follow Procedure
300
In March of 1997, the FDA issued these regulations that provide criteria for acceptance by the FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records, as equivalent to paper records and handwritten signatures executed on paper. (Hint: This is a section of the Code of Federal Regulations (CFR))
What is Part 11
300
A specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.
What is Batch (Lot is also acceptable)
300
USP (A scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide)
What is United States Pharmacopeia
400
This individual cannot independently close down operations of a facility, but rather can recommend such action to courts.
Who is an FDA Auditor
400
Enacted in 1992 and renewed several times thereafter, this act authorizes the FDA to collect user fees from pharmaceutical companies in order to expedite the approval process of their application.
What is the Prescription Drug User Fee Act (PDUFA)
400
Any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of diseases, or to affect the structure or any function of the body of man or other animals.
What is Active Ingredient
400
ANSI
What is American National Standard Institute
500
The number of days the site has to respond to FDA Form 483.
What is 15 Business Days
500
The Kefauver-Harris Drug Amendments of 1962 required drug companies to provide proof of these two things before approval would be granted.
What is Effectiveness/Efficacy and Safety
500
Showing an ability to take risks; confident and courageous. (Hint: Word that defines a powerful, global competitor.)
What is Bold
500
NSFW (If this is attached to a link, you’re strongly advised not to check it out while in the workplace or any other venue where inappropriate content would be, well, inappropriate)
What is Not Safe for Work