Unit 3 Building Quality Into the Product Flashcards
FDA
Governmental agency that sets standards for the manufacture of food and drugs
cGMP
Current guidelines for minimum standards set by the FDA to ensure the safety and purity
of food and drug products in the U.S. (reg quality)
BPR
Provides a detailed worksheet and a traceable record for each batch
21 CFR
Code of Federal Regulations that outlines all cGMP for drug, medical device, and
biological industries
SOP
Defines a particular procedure in detail so that it can be performed exactly the same way
every time
ISO 9000
Series of 5 international standards that guide the development of effective quality management systems (reg function)
validation
Proves that a process or equipment will consistently produce product to described
specifications
quality control
Checking and controlling raw materials and the product at each stage of
production
quality assurance
Ensures that everyone follows the SOP for every manufacturing step
The FDA can punish a company that is in violation of cGMP by imposing these
punishments:
fines, stop distribution of product, company shut down,and officials can be imprisoned.
the correct way to change a valve number recorded incorrectly in a BPR
((1)) cross out error only with single line ((2)) write correction next to crossed-out error ((3)) initial and date correction ((4)) write explanation for error that is not obvious (((ex))) Valve # (13-04)(crossed out) 23-04 ACS 09/01/03.
Review Military Time
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Types of Validation
Process, Equipment, system
