2. Quality: “Measure of excellence or a state of being free from defects,
deficiencies and significant variations.’’
Differences
Quality Assurance
QA is a set of activities for ensuring
quality in the processes by which
products are developed
QA is a managerial tool.
Establish a good quality
management system and the
assessment of its adequacy.
Periodic conformance audits of the
operations of the system.
Verification is an example of QA
Quality Control
QC is a set of activities for ensuring
quality in products. The activities
focus on identifying defects in the
actual products produced.
QC is a corrective tool.
Finding & eliminating sources of
quality problems through tools &
equipment so that customer's
requirements are continually met.
Validation/Software Testing is an
example of QC
3. Quality Management
QC
Techniques and activities
used to assure product
compliance to specification
QA
Quality through planned and
systematic activities like
validation process and
environment control and
documentation
Quality Management
4. Customer focus
Leadership
Involvement of people
Process approach
System approach to management
Continual improvement
Factual approach to decision making
Mutual beneficial supplier relationships
Principles in Quality Management
6. GMP:
It deals with section that guarantees that the
products are produced and examined within constant
quality system.
GMP guidelines build quality into the product.
Production is the center of the quality management
system. The quality of the production process is
monitored by self inspections, release control and in-
process control.
Pharmaceutical production guarantees that a stable
and repetitive product quality is maintained.
Aspects of Quality Management
7. Proper sampling & adequate testing
Imperfect composition
Missing ingredients
Sub-potent or super-potent addition of ingredients.
Mistakes in packaging or filling
Mislabeling
Lack of conformance to product registration
QA begin with raw material and components being
testing and include In-process, Packaging, labeling ,
and finished product testing as well as batch auditing
and stability monitoring.
Sources of Quality Control
8. Raw Material Control
Active Material
Antibiotics
Inactive or Inert Materials
In-process item control
Quality Control Programs adopted in
Pharma industry / Control of Quality
Variation
9. Good raw material specification must be written in precise
terminology, must provide specific details of test methods,
type of instruments and manner of sampling and must be
properly identified.
Quality assurance monograph
It states that components be received, sampled, tested, and
stored in a reasonable way that rejected material be disposed
of ,that samples of tested components be retained and that
appropriate records of these steps be maintained.
QA should keep preservation samples of active raw materials
that consist of at least twice the necessary quantity to perform
all tests required, to determine whether the raw material
meets the established specification.
Raw Materials Control
10. Active Material
Antibiotics
Inactive or Inert Materials
In-process item control
11. Environmental and microbiologic control and sanitation:
Personal cleanliness
Proper hair covering
Clothing
Floors, walls and ceilings should be resistant to external forces
Capable of being easily cleaned
Good repair
Adequate ventilation
Proper temperature
Proper humidity
Water supply may be potable, distilled, or deionized and must
be under adequate pressure to keep the water flowing.
Quality Assurance before Start-up
12. Lachman/Lieberman’s the theory and practice of
Industrial Pharmacy, Fourth Edition, Chapter # 29
Quality Management, Quality Control and
Assurance, page # 1073-1088
http://www.diffen.com/difference/Quality_Assuranc
e_vs_Quality_Control
Reference