CGMP Flashcards
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
Current Good Manufacturing Practices (cGMP)
he basic regulation to ensure that
manufacturers are taking proactive steps to guarantee
their products are safe and effective
GMP
was implemented by the FDA to
ensure continuous improvement in the approach of
manufacturers to product quality
CGMP
5 components of GMP
People
Products
Processes
Procedures
Premises
ensures products meet
intended use, comply with requirements, and
don’t risk consumer safety.
Quality management
crucial in
manufacturing to prevent contamination
from personnel, premises, equipment,
containers, and production materials
Sanitation and hygiene
Store production materials appropriately per
manufacturer-set conditions
Raw Materials
holds cgmp and food safety training
DOST and DTI
CGMP for Foreign Drug Manufacturers
FDA AO 2013-0022
CGMP in MANUFACTURING, PACKING..
DOH AO 153 S.2004
critical pillar of cgmp compliance
data integrity