Basic Concepts of QA $ QC
Basic Concepts of QA $ QC
and
Quality Management
concepts
What is Quality ?
Quality of a pharmaceutical Freedom from defects
product is measured by it's Degree of excellence
fitness for intended use.
Safety and efficacy are part of Customer/Buyer's satisfaction
quality. Compliance with specified/official
requirements
Efficacy
Safety
Quality
QA/ 4
QC
What is Quality Management?
WHO Definition :
The aspect of management functions that determines and
implements the 'quality policy'
Responsibility - To make a good quality of pharm. product
Product must comply with basic requirements
Identity
Strength/ potency
Purity
Basic Elements of QM
Quality system infrastructure & systematic actions
6
RELATIONS IN QUALITY SYSTEMS
QUALITY ASSURANCE (QA)
According to WHO, quality assurance is a wide-ranging concept
covering all matters that individually or collectively influence the
quality of a product.
With regard to pharmaceuticals, quality assurance can be divided
into major areas: development, quality control, production,
distribution, and inspections.
ISO 9000 defines QA as "part of quality management focused
on providing confidence that quality requirements will be
fulfilled"
CONCEPTS OF QA
Calibration
Validation
Qualificatio
n
Calibration