Fundamental knowledge on pharmaceutical product development and translation from laboratory to market. Quality management systems: Quality management & Certifications.  Si x sigma concepts.  Aim of 6 sigma concepts.  Process of 6 sigma concepts.

1. B.PHARM.VII-SEMESTER
BP702T.
INDUSTRIALPHARMACY-II(Theory)

2. QUALITYMANAGEMENTSYSTEMS
Dr. Ajay K. , Maharishi Arvind College of Pharmacy, Jaipur

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LEARNINGOBJECTIVES
After completing this presentation, you will be able to understand:
Six sigma concepts.
Aim of 6 sigma concepts.
Process of 6 sigma concepts.
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SIX SIGMA CONCEPTS

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 Six sigma concepts are a principle for the process improvement.
 Six sigma represents the quality level, implemented for reducing
the operational costs in pharmaceutical industry and serving the
best customer satisfaction and services.
 Six sigma is symbolized as “6σ”.
 Six sigma is a statistical measurement of product variables.
 This concept helps to achieve stable and predictable process
results with continuous quality improvement.
SIX SIGMA CONCEPTS

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 1. Process improvement
 2. Improved methodology
 3. Improved quality
 4. Customer satisfaction
 5. Reduction in process variation
 6. Reduction in costs
 7. Fewer defects to achieve the goal
 8. Continuous quality improvement
SIX SIGMA CONCEPTS
: Aim

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The concept is designed in “DMAIC” process.
DMAIC stands for
 Define
 Measure
 Analyze
 Improve and
 Control
SIX SIGMA CONCEPTS
: Process

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SIX SIGMA CONCEPTS
: Process

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SIX SIGMA CONCEPTS
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SIX SIGMA CONCEPTS
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 First and most difficult step of six sigma
approach.
 The basic aim of this step is defining the
problems and objectives.
 ‘Define’ explains project goal, aim,
difficulties, target magnitude and time span
to achieve the improved process.
SIX SIGMA CONCEPTS
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SIX SIGMA CONCEPTS
: Process
 process of collecting expected future data.
 The data
 will help to understand the magnitude of
improvement and
 will answer either the expected
improvement can be measured or not.
 The data is not necessarily quantitative.

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SIX SIGMA CONCEPTS
: Process
 The analysis of the whole process and helps
to understand the factors of influence.
 This is nothing but the analysis of raw data
to establish a correlation between input
variables and the possible output that
implies critical quality attributes (CQAs).

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SIX SIGMA CONCEPTS
: Process
 improvement of the process that has been
outlined in the define step to achieve the
expected outcome and result.
 The principles, specifications and process
outflow selected in the first step should be
improved and incorporated in the lifecycle
with fewer defects.

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SIX SIGMA CONCEPTS
: Process
 The improvement done in the last step
should be retained and
 additional procedures may be included in the
workflow.

16. B.PHARM. VII-SEMESTER BP 702 T. INDUSTRIAL PHARMACY-II (Theory)
DR. AJAY K. TIWARI, ASSOCIATE PROFESSOR
MAHARISHI ARVIND COLLEGE OF PHARMACY, JAIPUR (RAJ.)
AJAY81AJAY@GMAIL.COM WHATSAPP: 9782226444
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