Documents & Documentation
Written instructions designed to contain details on how to do a specific task correctly.
SOPs, STPs, MBR
A failure that is caught during the manufacture, before it reaches the marketplace.
Internal Failure
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
“… the minimum current good manufacturing practice…assure(s) that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristic…”
(21 CFR Part 210.1(a))
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
The 5 key elements of GMP are
People, Process, Products, Procedures and Premises
The minimum requirements that must be followed to assure that the products are safe, pure, effective and of the highest quality.
cGMPs
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
Purity, Safety, Quality, Strength and Identity
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.
Quality Records
Describes the overall intentions and direction of the company related to quality.
Quality Policy
The person/people who are responsible for product safety, quality and effectiveness.
All Noven Employees
ALCOA
Attributable, Legible, Contemporaneous, Original, Accurate
The consumer health protection agency that regulates the pharmaceutical industry.
FDA