GMP Flashcards

1
Q

Difference between manufacturer and production

A

Manufacture: involves everything (facilities, materials, people, production)

Production: the actual making of a product

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2
Q

Quality assurance and quality contro

A

Assurance= assured facility is good
Control= testing

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3
Q

Gmp definition

A

System ensuring that products are consistently produced and controlled according to quality standards to minimise risks

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4
Q

Gmp components

A

Materials
Machines
Processes
Procedure
People
Facilities
Documentation
Quality systems

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5
Q

Product quality review

A

Periodic review of all manufactured batches
Any changes spotted could be corrected

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6
Q

Defective product complaint handling system

A

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

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7
Q

Critical quality attributes

A

Physical, chemical or microbiological property or characteristics of a material which impacts the efficacy or safety of drug product

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