CHAPTER 3

GOOD MANUFACTURING
PRACTICES (GMPs)
 TOPIC OUTCOMES
• Demonstrate the legalism related to
manufacturing
• Demonstrate the standard operating
procedure in manufacturing
• Demonstrate the safety and health regulation
in GMPs
 Good Manufacturing Practices
• GMP refers to Good Manufacturing Practice
regulations stated by the US Food and Drug
Administration under the authority of the
Federal Food, Drug, and Cosmetic Act.
• sometimes referred to as "cGMP". The "c"
stands for "current,"
• It reminds manufacturers that they must employ
technologies and systems which are up-to-date
in order to comply with the regulation.
• These regulations, which have the force of law,
require that manufacturers, processors, and
packagers of drugs, medical devices, some food,
and blood take proactive steps to ensure that
their products are safe, pure, and effective.

• GMP regulations require a quality approach to

manufacturing, enabling companies to minimize
or eliminate instances of contamination, mixups,
and errors.
 ●
Qualificatio
Perso
nnel
ns
●
Training
Location
●

Design
Prem
●

Construction
●

ises Adaptation
●

Maintenance
●

●
Located

GMP Equip
ment
●

●
Designed
Constructed
Adapted

Regulations ●
Maintaned

Sanitati
Sanitati
on
on &
&
Hygiene
Hygiene

• Personnel
• Premises
• Equipment & Apparatus
• Production materials &
Containers
• Production for cleaning &
disinfection
• All potential of cross-
contamination
 Docu
Docu
menta
menta
tion
tion

Qualifica
Qualifica
tion
tion &
&
Validatio
Validatio
n
n

Compl

GMP
Compl
aints &
aints &
recall
recall

Regulations Self
Self
Inspection
Inspection
&
& Quality
Quality
Audit
Audit