Documents & Documentation
Written instructions designed to contain details on how to do a specific task correctly.
SOPs
A failure that is caught before and/or during the manufacture of product?
Deviation
The person/people who are responsible for the facility, quality system, organizational structure and ensuring adequate resources.
Management
Under the law, if a company is not complying with cGMP regulations, any drug it makes is considered ______.
Adulterated
WHO
World Health Organization
Records used to demonstrate compliance with internal policies, procedures, and regulatory requirements
GMP Documents
What do GMPs ensure?
Drug products are safe, pure and effective.
Department responsible for approval or rejection of components, raw materials, containers, closures etc.
Quality
OTIF
On Time In Full
"Notice of Inspectional Observations"
Form FDA 483
Finish the phrase: “If it isn’t documented,…”
it didn’t happen”
_______ cannot be tested into a batch of product but must be built into each batch of product during all stages of the manufacturing process.
Quality
The health protection agency that regulates the pharmaceutical industry is
FDA
The 5 cGMP characteristics of a drug are
Safety, Quality, Identity, Purity, Potency
It critically important to follow GMP regulation because
It’s the LAW.
These types of documents are legal documents and can be subpoenaed in a court of law as evidence.
GMP Records
Which group performs in lab testing of product quality?
Quality Control Group (QC)
The person/people who are responsible for product safety, quality and effectiveness.
Everyone
cGMPs
Current Good Manufacturing Practices
The consumer health protection agency that regulates the pharmaceutical industry.
FDA
These types of practices are used to ensure proper documentation is adhered to when documenting manufacturing related activities.
GDPs- Good documentation practices
A failure that is caught after the release of manufactured product to the market
Recall
The person/people most responsible for personnel accountability.
Yourself
ALCOA
Attributable, Legible, Contemporaneous, Original, Accurate
Pharmaceutical regulations across the world play an important role in ensuring the ______ and _______ of the approved drugs.
safety & efficacy