Study Set Content:
QA RESPONSIBILITY
everyone on the team
QA AS A TOOL
QA is a managerial tool
QC FOCUS
to identify defects in the finished product
QC GOAL
to identify defects after a product is developed and before it is released
QC HOW
finding sources of quality problems to continually meet customer's requirements
QC WHAT
analytical techniques used to maintain the product quality and process
QC RESPONSIBILITY
of a specific team that tests the product for defects
QC AS A TOOL
QC is a corrective tool
All manufacturing activities of a laboratory are
based on cGMP, AO 43, WHO guidelines, ISO,
EU.
quality management system
Part of QA which ensures that the products are
consistently produced and controlled to quality
standards appropriate for intended use.
CGMP (current good manufacturing proces)
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.
CGMP (current good manufacturing proces)
require a quality approach to
manufacturing, enabling companies to minimize
or eliminate instances of contamination,
mix-ups, and errors.
GMP regulations
This in turn, protects the consumer from
purchasing a product which is
not effective or
even dangerous.
benefits of CGMP
● Eliminates the risk of marketing unsafe products
● Guarantees conformance to regulatory requirement
● Guarantees product efficacy
● Reduces operating cost
● Reduces operating loss
● Produces higher employee morale
● Motivates health care professional to sell or prescribed the product.
It is an affirmation or proof that the products or
services are approved and evaluated by a
governing body that has the ability to create
reserved rights.
Certification
List of Certifying Agents
● ISO
● WHO
● FDA
● CH
● MHRA
● ASTM
● EPA
● TGA
● UKAS
ISO
(International Organization for
Standardization)
WHO
(World Health Organization)
FDA
(Food and Drug Administration)
ICH
(International Conference on Harmonization)
