Test 1 Flashcards
When did cGMP become prevelent
K-Harris Amendments 1962
What is ISO internal market certification
Increased market share
Higher quality
Reduced customer quality audits
Greater competition
Evidence based decision making is what
Sound Quality management principle
Technical requirements for the registration of pharmaceutical for human use is what
Main objective of ICH
ISO provides what
Standardization
ICH guidelines that cover cGMP followed in the manufacture of AIP are found where
ICHQ7A
What is the primary focus of QMP
To meet or exceed customer expectations
What is design validation?
involves ensuring the design conforms to it’s intended use by testing performance
The FDA’s CDRH compliance inspection which one is the most important
management
Component of design control that involves – Large scale to small scale translations
Design Transfer
CFR 211 PART 820
cGMP pharmaceuticals, quality system regulation for devices
device history and the master record have what in common?
Procedures and specifications
the consideration of human factor in device design
Design Input
Center for Device and Radiological Health
CDRH
Design and Dev. Planning
involves assigning personnel and responsibilities ans setting timeline
What is pre-market authorization
is required if a new device is not substantially equivalent to other devices and has not passed the 510K process
Most critical parameters for assisting purity
Cleaning procedures
Clinical Trial phase that testing out if the drug product will work for it’s intended use in humans?
Phase 2
What is the identity attribute of a drug
chemical or biological fingerprint of an active pharm. drug
3 is the minimum number of batches to prove product and process consistency for what?
when submitting NDA to the FDA
QC more than QA
conducts environmental monitoring
Consistency means?
quality should be maintained with each of the batch or lot manufactured
What is the stability of a drug
the quality of a drug does not change from the time the drug is manufactured to the time it expires
consistency of the ongoing process
Documentation
continuous improvement
testing
validation
ICH9 has what?
contains guidelines fro quality risk management
Quality by design is in what portion of the ICH
ICH 8
reaching a max # of ____causes the FDA to shut down the drug manufacturing company
27
What is process risk
concerns issues that can cause the product of failed specification during manufacturing
What is Product risk?
issues that can affect the success of the drug in the market place
Smoke studies
Hospira
bio burden
Alexicon
What is the 80/20 rule
avoid 80% of the fails by addressing 20% of the causes
What is Risk Mitigation
reduce or minimize the risk
What is detection
(check quiz 4 Q8)
Severity does what?
Measures the hazards to patients health
FMEA
Failure modes and Effect Analysis
A process that involves stating the product requirements and the assessing ways by which the product may fail
FMEA
