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 1 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 UNIDO Vienna March 2005 2 Question? ? ? UNIDO Vienna March 2005 Intended use F-1 Agriculture UNIDO Vienna March 2005 3 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 UNIDO Vienna March 2005 4 Regulatory inspections 2003 1 authority inspection / week (52) more than 1 international inspections / month (15) more than 1 FDA inspection / 2 months (8) UNIDO Vienna March 2005 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 5 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 UNIDO Vienna March 2005 6 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 UNIDO Vienna March 2005 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“ UNIDO Vienna March 2005 7 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 8 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 UNIDO Vienna March 2005 9 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 UNIDO Vienna March 2005 Quality and business will result in Pharmaceutical Excellence UNIDO Vienna March 2005 10