Show:
These Guys Mean Business
History Buffs
And by That, You Mean?
What's Up With All the Acronyms?
100
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
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
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 the Code of Federal Regulations
200
Legal consequences of not being compliant with cGMPs.
What are Fines/ Prison Terms/ Seizure and Quarantine of Product/ Close of Operations
200
This 1938 Act gave authority to the FDA to oversee the safety of food, drugs, and cosmetics. (Hint: Introduction of this act was influenced by the more than 100 deaths due to Elixir Sulfanilamide, a highly toxic chemical analogue of antifreeze)
What is the 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
Following an audit, the FDA form provided to a site for a Notice of Observations.
What is FDA Form 483
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 (the statistical sampling plan used to inspect finished product)
What is American National Standard Inspection
500
The FDA form provided to a site for a Notice of Inspection.
What is FDA Form 482
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
Any material fabricated, compounded, blended or derived by chemical reaction that is produced for, and used in, the preparation of the drug product.
What is In-Process Material
500
ROFL (Response to a funny text)
Rolling On the Floor Laughing