GMP Flashcards
Difference between manufacturer and production
Manufacture: involves everything (facilities, materials, people, production)
Production: the actual making of a product
Quality assurance and quality contro
Assurance= assured facility is good
Control= testing
Gmp definition
System ensuring that products are consistently produced and controlled according to quality standards to minimise risks
Gmp components
Materials
Machines
Processes
Procedure
People
Facilities
Documentation
Quality systems
Product quality review
Periodic review of all manufactured batches
Any changes spotted could be corrected
Defective product complaint handling system
Risk assessment
Receipt of complaint
Log into quality system
Request defective product
Check in house retained sample
Set up recall committee meeting
Initiate recall
Talk to regulatory
Critical quality attributes
Physical, chemical or microbiological property or characteristics of a material which impacts the efficacy or safety of drug product