TEVA PHARMACEUTICAL INDUSTRIES, USA

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1 TARO PHARMACEUTICAL INDUSTRIES, CANADA SUN PHARMA SUBSIDIARY TRUSTS IN WERUM S PAS-X MES FOR GENERIC MANUFACTURING PAS-X implementation at the strategic manufacturing site in Brampton, Ontario, Canada Taro Pharmaceutical Industries, a subsidiary of the world s fifth largest generic drug manufacturer Sun Pharma, has selected PAS-X for an MES pilot project at their manufacturing site in Brampton, Ontario. Here, the company produces generic liquids, crèmes and ointments. Taro is a multinational pharmaceutical company, dedicated to meeting the needs of its customers through the development and manufacturing of healthcare products. The initial implementation scope will cover Weighing & Dispensing and Electronic Batch Recording for compounding, filling, and packaging of one product family. Later, the system will be extended to a full-scope MES. PAS-X will fully integrate Taro s ERP system with the automation and equipment to ensure efficient and compliant data transfer. With PAS-X we aim to achieve a Right First Time factor of over 99 percent. Werum s MES will ensure compliance and certainty of our manufacturing data a prerequisite for improved process intelligence. Additionally, we will accomplish shorter cycle and review times. PAS-X will enable us to better utilize our resources leading to a better cost effectiveness, says Daryl LeSueur, Vice President, Brampton Site Head. CONTENTS TARO PHARMACEUTICALS, CANADA 1 TEVA PHARMACEUTICALS, USA 1 BIOPHARMA MANUFACTURING, USA 2 PT DANKOS FARMA, INDONESIA 3 TEVA PHARMACEUTICAL INDUSTRIES, USA WORLD S LARGEST MANUFACTURER OF GENERIC DRUGS USES PAS-X TRACK & TRACE FOR PACKAGING SERIALIZATION Low implementation and validation efforts due to selecting a standard product / Roll-out to packaging lines in Northern America and Europe GPO, THAILAND 3 WERUM AND ABB COLLABORATE 4 ZENITH TECHNOLOGIES, ENDORSED SERVICE PARTNER 4 WERUM ACQUIRES FACTORYTALK 5 QUALITY AND COMPLIANCE 5 REGULATORY AFFAIRS 6 NEW PAS-X MES WERUM AMERICA 8 In the context of their global serialization program, Teva Pharmaceutical Industries will roll out PAS-X Track & Trace at various sites in Northern America and Europe. Teva is the world s largest generic medicines producer with a world-leading position in innovative treatments for disorders of the central nervous system as well as a strong portfolio of respiratory products. For labeling and tracking their products, Teva needed a flexible IT solution to comply with the legal regulations of the countries in which the medical products are sold. The solution was to be based on a standard product to ensure a quick implementation and simple future upgrades. PAS-X Track & Trace covers all applicable legal regulations and can be adjusted to future requirements. It will be implemented widely out of the box and as a standalone solution. PAS-X Track & Trace will integrate the SAP ATTP and Optel Vision s packaging lines.

2 BIOPHARMA MANUFACTURING, USA PAS-X GO-LIVE AT GLOBAL LEADER IN HUMAN ANTIBODY TECHNOLOGIES Implementation of a full-scale MES at site in New York state / Seamless integration of IT landscape An American biotech company has successfully moved Werum s PAS-X MES into operation at their site in the state of New York. The company is the globally leading manufacturer of monoclonal antibodies mainly used for the treatment of cancer, rheumatoid arthritis and hypercholesterolemia. The biopharmaceutical manufacturer required an electronic production control system capable of integrating various IT system environments. PAS-X prevailed over competitor products in a multi-stage selection process. The PAS-X MES will ensure paperless production and documentation of all biopharmaceutical manufacturing processes at the site. It seamlessly integrates several Level 4, Level 3 and Level 2 systems such as Oracle ERP through certified, pre-configured interfaces. PAS-X was implemented using Werum s four-phased implementation approach Ready Fit Build Run. After the go-live of PAS-X in the weighing & dispensing, buffer and media preparation areas, upstream and downstream processing will follow. BIOPHARMA MANUFACTURING, USA GLOBAL BIOPHARMACEUTICAL COMPANY MIGRATES TO NEW PAS-X VERSION Werum s PAS-X MES controls blood plasma fractionation and plasma-derived production in Illinois / Accelerated batch release and transparent processes A global biopharmaceutical company has commissioned Werum IT Solutions with a PAS-X MES migration at their production and research site in Illinois. The company manufactures and markets a range of plasma-derived and recombinant therapies worldwide. The biopharmaceutical manufacturer is operating PAS-X V2 for weighing and blood plasma fractionation. As fractionation is to be performed in an additional building and the manufacturing of a new product is to be commenced, the system will be migrated to PAS-X V3.1.7 as a full-scope MES. PAS-X will be interfaced with surrounding IT systems such as SAP, LIMS and the shop floor automation equipment. The objective of the migration project is to accelerate batch releases and to make processes more transparent. 2

3 PT DANKOS FARMA, INDONESIA KALBE SUBSIDIARY INTRODUCES WERUM S PAS-X WEIGHING & DISPENSING AT JAKARTA PLANT IN ONLY SIX MONTHS Reduced implementation and validation effort through standardization / Full integration with Oracle EBS ERP PT Dankos Farma has successfully taken Werum s PAS-X Weighing & Dispensing and finished goods check-weighing system into operation at the pharma company s Jakarta plant in Indonesia. PT Dankos Farma is a holding of PT Kalbe Farma, the largest pharmaceutical company in Southeast Asia and one of the leading companies in the fields of consumer health and nutrition. PAS-X Weighing & Dispensing and finished goods check-weighing system was introduced while updating the IT systems and was fully integrated with the Oracle EBS ERP. As PAS-X is a standard product system which has also already been introduced at PT Kalbe Farma, our parent company, we were able to complete the project within the short term of only six months and, in addition, we could save validation costs, says Mr. Timotius Hokianto, PT Dankos Farma, Indonesia. The system provides built-in best practices workflows, barcode scanning and integration to weighing devices together with easy to follow steps for operator instructions in Indonesian Bahasa language. In a next step, the PAS-X installation will be extended to a full-scope MES and it will be rolled out at other plants. THE GOVERNMENT PHARMACEUTICAL ORGANIZATION, THAILAND THE LARGEST PHARMACEUTICAL MANUFACTURER IN THAILAND IMPLEMENTS WERUM S PAS-X AT ITS RANGSIT SITE First PAS-X MES implementation in the Thai pharmaceutical industry / Interfaces to ERP, LIMS and eqms for efficiency and compliance / Large benefits in quality, time-saving and reduction of lead time Werum s PAS-X MES went live at the Government Pharmaceutical Organization s (GPO) manufacturing site in Rangsit, Thailand the first in the Thai pharmaceutical industry. GPO is the largest pharmaceutical producer and distributor of important medicines for the Thai market. PAS-X has been implemented as a fullscope MES across the whole facility from the goods receipt of raw materials, warehousing, weighing, production and quality until shipment of finished products to the GPO nationwide supply chains. The MES integrates GPO s ERP and LIMS systems to ensure efficient data transfer. It is supported by an electronic QM system (eqms) under the concept of a fully integrated and electronic production site. PAS-X has enabled us to reduce paper records from the plant floor and replace them with an electronic and sequenced way of gathering the right data for the right product from the right authority at the right time. The review-by-exception functionality has also enabled departments within the manufacturing organization to start review- ing the events in real-time which saves time and reduces lead time for product release as the review can be completed in parallel with production, says Dr. Mukdavan Prakobvaitayakit, Director of Quality Assurance Department, GPO. The complete IT design and test and validation services were provided as a turnkey project to ensure the facility meets international GMP standards (PIC/s). The project was carried out locally by the Werum Asia Pacific Support Centre in Thailand. 3

4 Expanding partner network LEVEL 2 INTEGRATION ABB AND WERUM PARTNERING FOR INTEGRATED MES / DCS SOLUTIONS Collaboration on joint solutions for the life science industry ABB, the leading power and automation technology group, and Werum signed a memorandum of understanding to collaborate on control system solutions for pharmaceutical and biotechnological companies. These solutions will enable customers to benefit from leading industry expertise for process control systems (DCS) and production management software. The collaboration complements ABB s control systems offering with the latest MES technology, which is seen as a key component for efficient production in life sciences. The joint prototype solution has already been presented to the first customers. ABB and Werum will deliver full-scope engineering and validation according to the GAMP5 guideline in compliance with regulations such as FDA 21 CFR part 11. Our customers will benefit from integrated solutions paving the way towards the factory of the future, says Rüdiger Schlierenkämper, CEO at Werum. We look forward to working together with ABB on joint projects and to developing new ideas together. Driven by the innovative strength and global footprint of our two companies, we are well positioned to boost innovation for our customers. Werum s PAS-X MES combined with ABB s control systems will give our life science customers a seamless solution for their automation needs, says Ilpo Ruohonen, Managing Director of ABB s Control Technologies business unit. IMPLEMENTATION SUPPORT WERUM AND ZENITH ANNOUNCE GLOBAL MES PARTNERSHIP Customers benefit from best-in-class pharma MES combined with local implementation support Zenith Technologies and Werum formed a partnership to support pharma companies with the implementation of MES to improve production performance. The collaboration brings together Werum s PAS-X with Zeniths ability to integrate systems and provide on-the-ground automation technical support. The partnership makes Zenith an Endorsed Service Partner of Werum in the USA and Europe. Zenith will support Werum customers during all MES implementation phases, delivering comprehensive support and consultancy services that complement Werum s solutions. We are delighted to partner with Zenith Technologies, says Torsten Isenberg, Senior Director Services at Werum. As an Endorsed Service Partner, Zenith has the knowledge and experience required to be part of our PAS-X service partner program. Our objective is to ensure a high level of customer support through reliable and certified partners. Brendan O Regan, chair and founder, Zenith Technologies: Given our combined expertise in automation and the similarities in our customer base, the collaboration represents a strategic move. By combining Werum s MES with our technical implementation experience, we can provide customers with a high quality of service, training and local level support. After renewal of its status NNE Pharmaplan is Endorsed Service Partner for Europe (2016) and USA & China (2017). 4

5 EXPANSION IN ASIA PACIFIC WERUM EXTENDS PRESENCE IN ASIA PACIFIC BY ACQUIRING FACTORYTALK S MES BUSINESS Fully integrated and comprehensive solution hub for the benefit of Werum s existing and new clients in Asia Werum IT Solutions and Factorytalk Co., Ltd., Thailand, a leading consulting company for pharma manufacturers in Southeast Asia, jointly announce the complete transfer of Factorytalk s MES business to Werum s corporate organization. All current Factorytalk MES employees many of whom are long-term experienced MES experts will transfer into the newly established subsidiary Werum IT Solutions Ltd. in Bangkok, Thailand. This ensures continuation and is the sound basis for future growth of the operational Werum business in the Asia Pacific region. Factorytalk s ten year long collaboration with Werum and proven track record of success in implementing Werum s PAS-X MES working with qualified locally based consultants are the solid platform on which the business transfer is built. Through this initiative Werum can thus provide a fully integrated and comprehensive solution hub for the benefit of Werum s existing and new clients in Asia. This deal is about market leadership and growth. We highly welcome the opportunity to expand our local activities for Asian customers in this important future market together with Factorytalk a company with outstanding PAS-X MES and compliance expertise, says Rüdiger Schlierenkämper, CEO at Werum. The transfer of Factorytalk s MES business to Werum is an important step forward in realizing our future business growth strategy in the region. QUALITY AND COMPLIANCE CAN YOU SUPPORT QUALITY METRICS WITHOUT MES? GET READY TO BE GRADED ON A CURVE The FDA plans to conduct e-inspections based on quality metrics The Food and Drug Administration Safety and Innovation Act provides the FDA the ability to conduct electronic inspections and target onsite inspections based on metrics. The agency intends to request quality metrics data reports from the industry for a one-year period in electronic format. Analysis of these data such as the number of specification-related rejected lots of the product would be used to provide a company a Daniel R. Matlis grade, representing their fit on a curve. The FDA plans to develop a risk-based inspection schedule. Organizations that show their commitment to quality and have highly controlled manufacturing processes have the potential to be inspected less often than similar establishments that demonstrate uncontrolled processes. In the event an organization does not report the required quality metrics, the FDA may deem products manufactured at that establishment as adulterated and subject to enforcement action. The FDA s quality metrics e-inspections program is a key step in its objective to encourage the industry to implement innovative QM systems that drive companies to focus on improving product quality, rather than simply ensuring compliance. To support e-inspections, most companies will be forced to discontinue the use of paper batch records in favor of electronic batch record systems. Now is the time to act. Integrating MES with complimentary systems like QMS, PLM and LIMS will play a key role in achieving a single source of truth to support quality metrics reporting. On which end of the grading curve are you prepared to find yourself? 5

6 REGULATORY AFFAIRS RI MANAGER SUPPORTS EFFICIENT MANAGEMENT OF REGULATORY INFORMATION Centralized Regulatory Information Management (RIM) solution to efficiently manage your regulatory data, activities, processes, submissions and commitments RImanager is a centralized master data driven Regulatory Information Management solution based on PAS-X, which provides organizations the capability to manage their product portfolio with effortless compliance. It allows you to manage your master data as well as to plan and track related regulatory data, activities, processes, submissions and commitments across departments on a global scale. Connecting your regulatory and production processes RImanager manages all your product master data. Regulatory activities can be defined that store and track the information related to each product and its related submissions. As RImanager is built upon PAS-X, it can also be integrated tightly into your manufacturing processes. This ensures that information regarding labelling, formulation and drug safety remain in a single repository, allowing instant access for your end-users and providing essential management and regulatory reporting capabilities. Effectively manage your regulatory activities Effectively manage your regulatory projects RImanager also includes a set of project management tools to help you to structure your overall regulatory processes. Using the built-in task management tools, you can assign specific activities to departments or teams of users. Direct links between tasks and business objects such as manufacturing sites, products, formulations or submission documents allow quick access to related objects. For more complex processes, RImanager s workflow engine enables you to assign tasks in sequence to a number of users. The fully audited workflows can also be used to manage review and approval processes. GO-LIVE OF RI MANAGER AT HEEL Werum has successfully implemented RImanager at the pharmaceutical company Biologische Heilmittel Heel. Heel develops, manufactures and distributes medicines based on natural substances. The company is a pioneer in the field of scientific research in natural healthcare. Most known medicines are Traumeel, Zeel, Engystol, Euphorbium, Viburcol, Neurexan, Vertigoheel and Spascupreel. In several stages, Werum s RIM solution has replaced an outdated, self-developed system and has become the most important IT project in recent years at Heel after the implementation of SAP. The regulatory database contains all product data related to drug-approval and allows managing approval and authority activities e.g. if a medical product in a certain country has to be resubmitted or if the approval needs to be renewed. Key functions are the Product Dictionary to manage the products and product characteristics including all drug approval information as well as the Planning and Tracking -tool to plan, organize and track authority activities e.g. in the case of new applications, renewals and product variants. 6

7 PAS-X UPGRADE NEW PAS-X UNITES BEST IN CLASS MES FEATURES ON LATEST TECHNOLOGY PLATFORMS PAS-X SIMPLY THE BEST New capabilities ensure quality and address trends in pharmaceutical manufacturing Werum released the latest version of its market-leading PAS-X MES. The new PAS-X features several improvements for efficient manufacturing based on the latest technology standards. It not only facilitates regulatory compliance and data integrity, but also supports drug makers to ensure high quality in their manufacturing processes. Improved update capabilities Customers benefit from the reduced downtime for updating the software. We reduced the downtime by more than 50%, says Marcel Ecks, Head of PAS-X Infrastructure & Development Tools at Werum. We achieved this not only through technical improvements, but through a holistic approach involving the process itself and the documentation so that also the qualification efforts could be reduced. PAS-X allows a cumulative one-step MES product upgrade and data migration. It runs with the latest platform versions such as Oracle 12. Support of the new OSIsoft PI Event Frames simplifies integration of shop-floor systems. PAS-X ensures a smooth upgrade to the upcoming 3.2 version and it already provides the improved usability of the future operator GUI. Easy integration of PAS-X solutions PAS-X allows an even smarter integration of Werum s proven solutions such as Track & Trace, KPI/OEE and the new Evaluations Package. PAS-X Evaluations helps pharma manufacturers unlock the full potential of shop floor data. Median Review Time (h) 0 h 56 h Material Group HEADGREEN HEADGREENE HEADBLUE HEADPINK Grand Total Signature Type DRAFT Review by Technical Review by Production Review by QA Grand Total Q May June July 81 h 24 h 13 h Analysis of Batch Record Report review times with the new PAS-X Evaluations Package Q3 August September Material Group: HEADBLUE Week of Signature: 28 Jul 14 # Batches: 13 Total Review Time: 301h (Min / Avg. / Median / Max): 2h / 23h / 20h / 67h 182 h 301 h Simply the best with all 3.1 features The latest trends in pharmaceutical manufacturing have been considered in the new PAS-X. PAS-X is future-ready, says Robert Welter, Senior Head of PAS-X Product Management at Werum. Our user forum PAS-X For Us actively participated in advancing the product. With the latest PAS-X release, pharma manufacturers benefit from a comprehensive compilation of innovations, functionalities and usability improvements that Werum introduced throughout the PAS-X 3.1 family. For example, customers benefit from automated execution features such as material flow and equipment identification, each of which improve user efficiency and reduce risk of human error. Data integrity is supported by alarm & events, directly retrieving GMP-relevant exceptions from level 2 systems. Upgrade now to PAS-X PAS-X contains the experiences and best practices of decades of MES projects in all areas of the pharma and biotech industries. Several customers have already decided to go for PAS-X benefitting from reduction of project specific customizations that can be replaced by best practice content and standard functionality. Thorsten Grundmeier, Senior PAS-X Consultant at Werum: With PAS-X 3.1.8, the most sophisticated and pharma-dedicated MES in terms of functionality and usability becomes available on the market for customers in any region, from small- to large-scale production. It is simply the best solution to fully utilize the key benefits of MES for pharma and biotech: compliance, quality and performance. 7

8 WERUM AMERICA CLOSER TO OUR CUSTOMERS: WERUM HIRES SENIOR MANAGER FROM THE PHARMA INDUSTRY Robert Perks appointed Vice President Operations, Werum IT Solutions America Werum America extends its management team with additional first class external expertise: Robert Perks joined Werum IT Solutions America and assumed the position of Vice President Operations on April 1, In this role, he will direct Werum Americas team of project managers and engineers to ensure the successful implementation of Werum s best in class MES solutions. Working more than 20 years for major pharmaceutical and plant manufacturers, Robert Perks has world class management experience in life sciences and medical devices. He relies on a profound knowledge base in designing and implementing manufacturing projects ranging from standard out-of-the-box solutions to complex, fully integrated systems. Robert has comprehensive experience in project management with exceptional technical acumen, customer focus, and global program management experience. Robert Perks is co-chair of the ISPE Community of Practice for PAT & Lifecycle Control Strategy and has given podium presentations at both ISPE and PDA annual meetings on innovation, quality and compliance improvements at pharmaceutical manufacturing facilities. Robert Perks Before joining Werum, he worked for 13 years in management positions at Baxter Healthcare Corporation where he was responsible for the planning and implementation of automation and MES systems. Contact: Werum IT Solutions America, Inc. 5 Sylvan Way Parsippany, NJ USA T F info@werum-america.com IMPRINT: Werum IT Solutions GmbH (world HQ) Wulf-Werum-Str Lüneburg Germany T F info@werum.com 8