Study Set Content:
Degree of Excellence
Quality
Sum of all factors which contribute directly or
indirectly to the safety, effectiveness, and
reliability of the product.
quality
Totality of features or characteristics
quality
Conformance to specifications
quality
Sum of all tests performed to determine the
conformance of the product to specification
quality control
Part of cGMP concerned with sampling, testing,
specifications, organization, documentation and
release procedures
quality control
quality control guarantees that the product:
○ Is free from impurities
○ Physically and chemically stable
○ Contains the amount of active
ingredients as stated in the label
○ Provides optimal release of active
ingredients when the product is
administered
RM and PM Analysis
Routine:
Intermediate Stage Analysis
Routine:
Calibration & Preventive maintenance of
Instruments
Non-Routine
Preparation of reference/working standards
Non-Routine:
Finished product Analysis
Routine:
Stability Studies
Routine:
Method development and validation
Non-Routine:
Over-all organizational body designed to assure
product quality
quality assurance
Sum of all processes performed to ensure that
the product possess all the characteristics it is
intended to have.
quality assurance
to prevent defects with a focus on process
QA Focus
QA GOAL
to improve development and test processes so that defects do not arise
QA WHAT
prevention of quality problems through planned and systematic activities
QA HOW
establish a good QMS and assessment of its adequacy with continuous monitoring
