contains notes about quality assurance in herbal industry and total quality management

1. INDUSTRIAL PHARMACOGNOSTICAL
TECHNOLOGY
Topic: Quality Assurance in Herbal/natural
drug products and Concept of TQM
Presented
By
P M Mohamed Insaaf,
M.Pharm 1st Year,
Department of Pharmacognosy,
College of Pharmacy, Madras Medical College,
1

2. INTRODUCTION
• Quality
assurance of
herbal medicinal
products is the
shared
responsibility
of
manufacturers
and regulatory
bodies.
2

3. INTRODUCTION (CONTINUED)
• National drug regulatory authorities have
to establish guidelines on all elements of
quality assurance, evaluate dossiers and
data submitted by the producers, and
check post marketing compliance of
products with the specifications set out by
the producers as well as compliance with
Good Manufacturing Practice (GMP).
3

4. INTRODUCTION (CONTINUED)
• The manufacturers have to adhere to
Good Agricultural Practices (GAP),
Good Manufacturing Practices (GMP)
and Good Laboratory Practice (GLP)
standards, establish appropriate
specifications for their products,
intermediates and starting materials and
compile a well structured,
comprehensive documentation on
pharmaceutical development and
testing. 4

5. INTRODUCTION (CONTINUED)
• The producers should make continued
efforts to improve standards and adapt
them to the present state of knowledge.
• A cooperative approach between
different manufacturers. E.g By
establishing drug master files for
specifications and quality control, should
be encouraged.
5

6. WHO DEFINITION OF QA
• It is the totality of
the arrangements
made with the object
of ensuring that
pharmaceutical
products are of the
quality required for
their intended use.
QA = QC + GMP
6

7. INTRODUCTION (CONTINUED)
• According to QA producers are designed and
developed in a way that takes account of
the requirements of GMP and other
associated codes such as those of Good
Laboratory Practices (GLP) and Good
Clinical Practice (GCP).
• Product and control operations are clearly
specified and GMP requirements are
adopted.
• Arrangements are made for the
manufacturing supply and use of correct
starting and packaging material.
7

8. INTRODUCTION (CONTINUED)
• All necessary controls on starting
materials, intermediate products and bulk
products and other in-process controls,
calibrations and validations are carried
out.
• The finished products are correctly
processed and checked according to
defined procedure.
8

9. ELEMENTS OF QUALITY
ASSURANCE
• Adherence of GACP, GMP and GLP guidelines.
• Setting specifications.
• Quality control measures.
9

10. QUALITY ASSURANCE INCLUDES
• cGMP (Current Good Manufacturing Practices)
• GAP (Good Agricultural Practices)
• GMP (Good Manufacturing Practices)
• GLP (Good Laboratory Practices)
10

11. 5 M's OF QUALITY
• Man
• Material
• Machinery
• Manuals/ Methodology (SOP)
• Money
11

12. QA ACTIVITIES
• Technology Transfer
• Validation
• Documentation
• Assuring quality of products
• Quality Improvement Plan
12

13. QA VERIFICATION
• Business
• Manufacturing
• Quality
• Product
13

14. Several Problems not applicable to
synthetic drugs influence the quality of
herbal drugs
• Herbal drugs are usually mixtures of many
constituents.
• The active principle is and in most cases
unknown.
• Selective analytical methods or reference
compounds may not be available commercially.
• Plant materials are chemically or naturally
variable.
• The source and quality of raw material are
variable.
• Hence, for the remedy Quality Control is
required.
14

15. QUALITY CONTROL
• Component of a QA program.
• Procedure control.
• QC process involves checking all the
operational procedures whether they are
performed correctly.
• The QC chemists must ensure that they
meet standards at all time.
• Right to test all the levels
• QA will evaluate all the testing results at
all the levels and give approval for further
processes.
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17. INTRODUCTION
• Total - made up of the whole.
• Quality - degree of excellence a product
or service provides.
• Management- act, art or manner of
planning, controlling, directing.....
• Therefore, TQM is the art of managing the
whole to achieve excellence.
17

18. DEFINITION
• Total Quality Management (TQM) has been
defined as an international organization
effort designed to improve quality at every
level.
• According to International Organization for
Standards (ISO), TQM is defined as, " a
management approach for an
organization, centered on quality, based on
the participation of all its members and
aiming at long term success through
customer satisfaction and benefits to all
members of the organization and the
society.
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19. PRINCIPLES OF TQM
• Focus on the customer.
• Employee involvement.
• Process centered.
• Integrated system.
• Strategic and Systematic approach.
• Continuous improvement.
• Fact based decision making.
• Communications.
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20. CHARACTERISTICS OF TQM
• Committed management.
• Closer customer relations.
• Closer provider relations.
• Increased training.
• Employee empowerment.
• Flexible production.
• Process improvements.
• Process measuring.
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22. CATEGORIES OF TQM
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23. ELEMENTS OF TQM
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24. MANAGEMENT OF TQM
• Strategic commitment.
• Employee involvement.
• Materials
• Technology
• Methods
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25. BENEFITS OF TQM
• Improves reputation.
• Higher employee morale.
• Lower cost.
• Improve teamwork.
• Improve customer satisfaction.
• Improve organizational productivity.
• Attain higher profitability and increased
market share.
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26. TOOLS USED IN TQM
• Histogram
• Pareto chart
• Cause and effect diagram.
• Defect concentration diagram.
• Control chart.
• Scatter diagram.
• Check sheet.
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27. DISADVANTAGES OF TQM
• Production disruption.
• Employee resistance.
• Quality is expensive.
• Takes years to show results.
• Demands a change in culture.
• Discourages creativity.
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28. IMPORTANCE OF TQM IN
PHARMACEUTICAL INDUSTRY
• Handling.
• Storage.
• Packaging.
• Facilities and equipments.
• Sterile areas.
• Labeling.
• Computerized systems.
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29. CONCLUSION
• TQM encourages participation amongst employees,
managers and organization as whole.
• Using Quality management reduces rework nearly to
zero in an achievable goal
• The responsibilities either its professional, social, legal
one that rest with the pharmaceutical manufacturer for
the assurance of quality of product are tremendous and
it can only be achieved by well organised.
• Work culture and complete engagement of the
employees at the work place.
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30. CONCLUSION
• It should be realised that national &
international regulations must be
implemented systematically and process.
• Control should be practiced rigorously.
• Thus quality is critically important ingredient to
organisational success today which can be
achieved by TQM, an organisational approach
that focusses on quality as an over achieving
goals, aimed at aimed at the prevention of
defects rather than detection of defects..
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31. REFERENCES
• Text book of Total Quality Management by
L.Suganthi and Anand A.Samuel,2nd edition,
2005.page no.49-61.
• Total Quality Management by R.S Nagarajan,
A.A.Arivalangar, new age international
publishers,1st edition,2009,page no.21.
• www.slideshare.com/tqm in pharma industry.
• https://en.wikipedia.org/wiki/Total quality
management.
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32. REFERENCES
• https://managementhelp.org/quality/total-quality-
management.htm.
• https://www.isixsigma.com/methodology/total-
quality-management-tqm/eight-elements-tqm/
• http://aboutthree.com/blog/five-important-factors-
in-total-quality-management/
• A textbook of Industrial Pharmacognostical
Technology by Dr. Md. Rageeb Md. Usman,
Sanjay A. Nagdev, Rahul W. Gawali and Tanvir
Y.Shaikh, Pee Vee publication, pg no 59-60.
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