Quality Management at Sandoz Quality? Yes…. Why? Where? When? 1

Quality Management at Sandoz
Santiago Alonso/ QA Sandoz
Vienna , March 2005
a Novartis company
Quality? Yes…. Why? Where? When?
How? How much?........ Really?
a Novartis company
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Agenda
• High Quality concept as core value
• What is different in Sandoz
• What are we going to sell regarding quality
UNIDO Vienna March 2005
High quality concept as core value
Out-side perception values of Sandoz name were
defined as our core values:
• High Quality
• Global Presence
• Innovation
To compete in the High Quality generics market is part of
our vision
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Question?
?
?
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Intended use
F-1
Agriculture
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High Quality concept as core value
•
Ø
What is considered quality?
•
Ø
What is behind adequacy of use in producing medicines?
Adequacy of use : the products and services provided by our company have
the characteristics that are expected to have for the intended use.
Product has to have the adequate quality attributes,
safety and efficacy as defined by the registration dossier
during the period of possible use (release till expiry date)
UNIDO Vienna March 2005
High Quality concept as core value
• What is the target of any medicine?
Ø Treatment of individuals affected by a determined pathology
Ø No difference between Gx and Originator products.
•
We claim High Quality as one of 3 Sandoz core values and future vision.
• What is considered High Quality?
Ø Highest rate of performing activities meeting the defined and ex pected
characteristics of the product, process, services and activities
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Regulatory inspections 2003
1 authority inspection / week (52)
more than 1 international inspections / month (15)
more than 1 FDA inspection / 2 months (8)
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Regulatory inspections 2004
Number of Inspections by any regulatory authority: 58
Number of International inspections: 22
Number of sites regularly inspected by FDA: 13
2 additional in 2005 (India-Kalwe/Dev.Center Kolshet)
in addition 3 EMEA GCP inspections
UNIDO Vienna March 2005
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Agenda
• High Quality concept as core value
• What is different in Sandoz
• What are we going to sell
UNIDO Vienna March 2005
Quality and business – aspiration
We like to focus our Quality efforts to support business
• By achieving compliance as key element for business
continuity
• By achieving high level of quality of activities as key element
for competitiveness of our products
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What are the key elements of compliance?
Key elements of compliance
• Personal responsibility and discipline
• Traceability of facts by documentation
• Scientific judgment of the facts
Compliance is more than words
Compliance is a life style
Compliance needs know-How
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Competitiveness of our products?
It requires high level of reproducibility of
• Processes
• Products
• Activities
fulfilling the established requirements,
providing a high rate of „acceptable actions“
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How we differentiate Sandoz
By understanding as Company
Ø That we are selling special goods that require from us special ethical
behavior: medicines
Ø That our primary target in doing business by selling medicines has to
be: Health and safety of the consumers
Ø That we have contracts signed with the consumers: The Marketing
Authorizations
Ø And this contracts must be followed as any other contract
UNIDO Vienna March 2005
Agenda
• High Quality concept as core value
• What is different in Sandoz
• What are we going to sell regarding quality
UNIDO Vienna March 2005
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Quality and Business vision of superior quality and
compliance
Commitment to quality:
• considering quality of any activity, process, product etc. in any area
of the daily work. Our customers must get the perception that their
satisfaction regarding usability of our “Company Deliverables” is a
1st priority for us
Self-discipline,
•
This is a pillar of high rate of “acceptable actions” from the personal
point of view of each individual. Discipline is not against necessary
flexibility in the generic business.
UNIDO Vienna March 2005
Quality and Business vision of superior quality and
compliance
Attitude of excellence
Ø do better, do more, do quicker than expected, exceeding internal
and external customer expectations. We understand this in this
order. It is not the same: do quicker, do more and if at the end it is
better ……this was by chance
Desire of improvement:
Ø basic for moving to high Quality levels. If we are working we are
going to make mistakes. Important is to share those with others to
be able to avoid repetition
Personal character:
Ø what are you doing when nobody watches you?. I behave ethically
and not only by control
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Quality and Business vision of superior quality and
compliance
Company culture
Ø As you can understand if we are able to make reality all this
concepts we are ending in a company culture.
Ø Irrespectively of the area we are working with we are looking for
quality of each activity
Ø This is moving internally the excellence of our processesat all levels
Ø And externally the perception that SANDOZ has
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Quality and business will result in
Pharmaceutical
Excellence
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