CGMP Flashcards

1
Q

a system that consists of processes, procedures
and documentation that ensures manufacturing
products, such as food, cosmetics, and
pharmaceutical goods, are consistently produced
and controlled according to set quality standards

A

Current Good Manufacturing Practices (cGMP)

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2
Q

he basic regulation to ensure that
manufacturers are taking proactive steps to guarantee
their products are safe and effective

A

GMP

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3
Q

was implemented by the FDA to
ensure continuous improvement in the approach of
manufacturers to product quality

A

CGMP

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4
Q

5 components of GMP

A

People
Products
Processes
Procedures
Premises

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5
Q

ensures products meet
intended use, comply with requirements, and
don’t risk consumer safety.

A

Quality management

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6
Q

crucial in
manufacturing to prevent contamination
from personnel, premises, equipment,
containers, and production materials

A

Sanitation and hygiene

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7
Q

Store production materials appropriately per
manufacturer-set conditions

A

Raw Materials

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8
Q

holds cgmp and food safety training

A

DOST and DTI

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9
Q

CGMP for Foreign Drug Manufacturers

A

FDA AO 2013-0022

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10
Q

CGMP in MANUFACTURING, PACKING..

A

DOH AO 153 S.2004

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11
Q

critical pillar of cgmp compliance

A

data integrity

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