Healthcare. Pharma & Biotech Medical Technologies Health & Nutrition

Transcription

1 Healthcare Pharma & Biotech Medical Technologies Health & Nutrition

2 Altran Healthcare Practice Altran is a global service provider to the Healthcare industry and assists companies throughout the whole value chain from the development and manufacturing of medicinal products and medical technologies to the care delivery to the patient. We supports companies in all phases of the product development and manufacturing through adapted strategic, operational, technological and financial business solutions addressing some of the key challenges of this sector: - Operational efficiency and cost optimization, - R&D and clinical trials optimization, - Quality performance and regulatory compliance, - Externalization and increasing globalization. With four branches in Switzerland (Geneva, Lausanne, Zürich and Montreux), Altran AG delivers high quality healthcare consulting services and training to Swiss life sciences entities active within the Pharmaceutical, Biotechnological and Medical Technologies industries. Altran AG provides support in the following areas: R&D Operational Efficiency Quality Assurance Product/Process Development Manufacturing Technologies Innovation Technology Transfer Facility and Equipment Design Operational Efficiency and Technical Operations Audit Quality Assurance Qualification and Validation Training Altran Healthcare practice has a global network of over 900 dedicated consultants in more than 15 countries, working locally on projects of our 130 active customers. Research & Development Scope Product/Process Development: During the development phase of new products, Altran assists customers in defining processes that will meet the constraints of commercial manufacturing. During the development phase, Altran s main objective is to make sure that requirements or specifications from manufacturing site are highlighted in order to avoid unnecessary and costly development work. Our main driver is to assure communication and information between R&D and Technical operations in order to secure a successful technology transfer phase by involving stakeholders from both areas. Manufacturing Technology Assessment: Our team of experts has acquired a long experience in Pharmaceutical and Biotech processes. We assist our customers in selecting manufacturing technologies and equipment through feasibility studies based on future product requirements, forecasted volumes and available manufacturing capacity. Innovation: Altran s methodology combines the best innovation techniques with a solid system & project management approach. Built on 6 key elements: reducing psychological inertia, solution space / directions, creative thinking, subject knowledge, climate and emotion setting elements that are all integrated through a generic and modular process that is individually adapted to specific client needs. Our dedicated team can help you by combining following sources of methodologies, theories & hands-on innovation experience: Theory of Disruptive Technology Find out & predict: new markets, market evolution, market threats, technological threats, how to manage new technologies. Theory of Inventive Problem Solving TRIZ and TRIZ+ / ARIZ Methodologies. Lead Users Approach and Democratizing Innovation. Methodology for Systematic Innovation & Inventive Problem Solving (ALTRAN Group) It combines the world s best innovation techniques and strategies with a solid project approach to open totally new orientations within a very short time frame. Altran Synectics Approach Developed by Altran Synectics Company in Boston, USA; Creativity & Innovation Methods beyond brainstorming.

3 Operational Efficiency Scope Technology transfer The development and transfer of knowledge and technology has been and will continue to be critical to suceed in Life Sciences industries. Process development and commercial production are on the critical path because of compressed time-to-market expectations. After the development phase, the next step is the Technology transfer. Altran supports this activity between: - Development laboratory to manufacturing site, - Two manufacturing sites within the same company, - Product owner company to contract manufacturing organization (CMO). Altran s area of intervention encompasses: - Technology Transfer Project management or project member, - Manufacturing site identification, assessment and selection, - Design and selection of manufacturing equipment / facilities based on commercial volume expectations, - Process transfer and trials execution, - Process Validation, - Preparation of regulatory file prior to submission. Facility and Process Equipment design Altran provides support in the design and selection of new facilities, manufacturing areas and process equipment. The goal is to offer the best possible solutions following current manufacturing regulations (cgmp) and EHS regulation. These solutions shall take into considerations process, personnel, material flow and future extension requirements in order to provide efficient installations. OPERATIONAL EFFICIENCY AND TECHNICAL OPERATIONS Operational efficiency and cost reduction are key concerns of Life Sciences industries. To meet these concerns Altran provides Organizational and IT consulting services throughout the industrial process, including research, development, manufacturing, sales and support operations. Based on proven methodologies such as Six Sigma and Lean Management, Altran supports customers in improving manufacturing, sales, and research or development efficiency thereby obtaining cost reduction, improving productivity and reducing operational constraints due to compliance and regulation issues. Leveraging the power of IT goes hand in hand with improving operations. Altran is a key supplier of IT services for the healthcare industry. The range of our services go from planning, i.e. defining Governance best practices, gathering requirements and reviewing business processes to designing Information System Architecture (SOA, Master Data Management) and implementing cutting edge bespoke applications that support operational efficiency endeavours. Four areas stand out particularly and are at the heart of our IT service offering: ECM for Healthcare, Business Intelligence, Enterprise Architecture/Master Data Management and Governance. ECM which stands for Enterprise Content Management is perhaps one of the most important elements to address and provides many compelling business cases. Our unique mix of industry knowledge and ECM know-how allows us to harness the power of Content Management System, from collaboration and earchiving, to planning and designing ECM Solutions tailored to the specific requirements of the Healthcare industry. Our solutions aim to improve and streamline Quality, Clinical, Regulatory and Corporate Operations. They are based on industry standards such as Documentum, MS Sharepoint Oracle and other software. ECM Solutions for healthcare: Collaboration Document Management Publishing Record Management & Compliance Entreprise Information Management Product Development Portfolios R&D (compounds, Discovery dbs etc.) Clinical Trials Internet/ Intranet Extranet & Portals ectd ECM Strategy External collaboration (ARC, CRO, Universities) Regulatory documents Compliance (21 CFR part 11 etc.) Information Architecture Collaboration Manufacturing Information GxP support, QMS On Line Communication/ e-learning e-archiving Change Manaagement

4 Quality Assurance Scope Audit Compliance Audit: Performed at your suppliers site or internally, our audits take a snapshot of a Quality System to check its compliance regarding regulations and guidelines. Assessment Audit: Our auditors investigate in detail your quality system to identify the right opportunities to sustain your continuous improvement process. Audit: Quality Assurance Compliance: Our QA dedicated team assists you in resolving regulatory gaps identified during a compliance audit. Operational Quality Assurance: Our sound experience in QA enables you to get the best support in day to day quality systems management activities. Quality System Optimization: We commit along with your QA leaders to upgrade your Quality System structure following regulatory, business and organization evolutions. Quality Assurance: Quality System Optimization

5 Qualification and Validation Altran has acquired a strong knowledge in qualification and validation activities for process, equipment, utilities (HVAC, Purified Water...) and facilities. For regulatory acceptance of investment, we provide commissioning and qualification until process validation following the industry s best practices (ASTM E2500 version 2007 and ISPE Engineering Baseline Guide Volume 5 for Commissioning and Qualification version 2003). Validation V-Cycle: Training We have developed training modules to guarantee that your resources will receive the most updated knowledge on the industry s best practices and regulations on the following subjects: Introduction to GMPs (Good Manufacturing Practices) for Pharmaceuticals. Building Compliance in Process Development: Lab Bench to Market Production. GMP Compliance for Biopharmaceutical API Manufacturing. Compliance for Biopharmaceutical API Process Validation. Process Analytical Technology (PAT) and Quality by Design (QbD). How to Implement 21 CFR Part 11 Regulation and its Guidance s. About Altran Altran is the European leader in innovation and high-technology consulting. The Group employs more than 17,500 consultants worldwide who represent the entire range of engineering disciplines, broken down into four major business lines: technology and R&D consulting; organisation and information systems consulting; strategy and management consulting and Education Services. Altran works with companies throughout the innovation process, including technology intelligence, applied basic research, management consulting, industrial systems engineering and information systems- from systematic ideation, technology strategy, R&D to production. In Switzerland, Altran employs more than 200 consultants.

6 Some project references Context & Objectives Approach & Solution Results & Added Value Client required the consultant to support and coordinate regulatory compliance activities of their facility before an FDA inspection (21 CFR part 210 & 211/ 21 CFR PART 820). Mock audits on: Management, Documentation Management, Qualification-Maintenance, Validation, Deviation/CAPA, Complaints &Purchasing) Supplier audits: Chemical methods validation, Packaging I, Excipients & reagents, API GMP training & coaching: Basic cgmp,qms, Warehouse-Clean Areas-Quality Control & FDA Inspections FDA inspection passed successfully Completion of 7 Mock Audits to FDA agreement Completion of 7 supplier Audits Provision of GMP Training & Coaching (4 modules / 140 people) Support the US and EU regulatory compliance of their facility Carrying out an audit of their utility installations (WFI, PW, CS, and HVAC ) Carrying out a GAP analysis and defining the subsequent action plan for implementation of improvement steps Carrying out periodic reviews Audit completed successfully Action plan created for areas of non-compliance Action plan created for areas of improvement on installations Realize a feasibility study concerning the extension of its PW system Feasibility study of PW systems Design & Build support Installation & project completion 2 new washing/cleaning equipment connected in the production area Technical Evaluation of a solid dosage form process Review the current process going through regulatory file, materials, equipment, process, manufacturing conditions, analytical methods Evaluate all actions taken internally and their effect Definition of a methodical approach to gather data and information regarding the current issues Geneva Lausanne Zurich Quai du Seujet 16 CH-1201 Geneva Phone Fax Avenue de Savoie 10 CH-1003 Lausanne Phone Fax Seestrasse 513 CH-8038 Zurich Phone Fax contact: altran@altran.ch