This document discusses quality management, quality assurance, and quality control in the pharmaceutical industry. It defines quality and describes the differences between quality assurance and quality control. Quality assurance ensures quality through planned systematic activities like process validation and documentation, while quality control finds and eliminates quality problems through testing. The document also outlines principles of quality management like customer focus, leadership and continual improvement. It describes aspects of quality management like quality assurance, quality control, GMP, and production control. Finally, it discusses techniques used for raw material control, in-process control, and environmental control in pharmaceutical quality management systems.

1. Quality Management
Dr.Zulcaif Ahmad

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

5. Quality
Management
Quality Assurance
GMP
Quality Control
Production
In-process
control
Release
control
Self
Inspection
Aspects of 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