The Product Centric Supply Chain (including workshop notes)

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1 The Product Centric Supply Chain (including workshop notes) David Stokes Global Head, Life Sciences Pharma Supply Chain Directors Dialogue th June 2013

2 Think About the Product Product Identify the people, processes and technology that use product data in your supply chain

3 Think About the Data What data are associated with the product? Multiple items of data and metadata including product names (chemical and brand names in different markets), product descriptions, product codes, bills of material (and versions thereof), master and control recipes (and versions thereof), formulations (and versions thereof), therapeutic data (treatment and side effects), product costing, SKUs, valid serial ranges, manufacturing plants and lines, suppliers, supply chain model, forecasts and schedules etc

4 Think About the Stakeholders Who are the product stakeholders? Inside your organisation Manufacturing, Drug Development, Regulatory Affairs, Quality, Planners, Schedulers, Buyers, Sales, Marketing, Finance, Accounts etc Outside your organisation Collaboration partners Suppliers, Contract Manufacturers, Licensors, Customers, Patients, Regulators, Distributors, Wholesalers etc

5 Think About the Processes Which processes use product information What is the first process in your supply chain that uses product information? The first customer facing process. Depending on the organisation this could be forecasting, sales or order entry What is the last process in your supply chain that uses product information Depending on the organisation, this could be shipping, distribution or returns Which processes lie in between? This includes all normal supply chain processes, plus exceptional processes such as product recall

6 Think About the Systems Which business systems use product information? To identify business systems it is useful to think about Which stakeholders use which systems? Which processes are supported by which systems? What data are supported in which systems? This will always include ERP, but also demand planning and scheduling, Sales/CRM, MES, LIMS, process control and automation, WMS, distribution and logisics etc

7 Think About the Product Lifecycle When in the product lifecycle do supply chain professionals need visibility of product data? From drug development (common in medical devices, where product development is part of GMP) but increasingly in pharmaceuticals with growing regulatory expectations for better coordination between R&D and manufacturing during scale-up Drugs are increasingly being designed (chemistry and formulations) for lower cost manufacturing To 10+ years after final product supply Depending upon the type of product, this could be years (much beyond the life of any transactional system)

8 Product Data Challenges What challenges do we have with our product data? Inconsistency of data formats leads to inefficiency when exchanging data Can be a problem between supply chain systems within a manufacturer Can be a larger issue when dealing with complex supply chains and third parties Can add days/weeks to a supply chain cycle Can require significant rework to resolve Conflicting versions of product data leads to quality/regulatory issues and further inefficiencies

9 Product Data Opportunities How can business processes be streamlined through the use of consistent product data? Use of consistent master data What rework can be avoided through the use of consistent product data? Manual editing/re-entry of data, On-going data cleansing What cost savings can be achieved through the use of consistent product data? Varies depending on the size of the product data problem (negligible to significant [up to 3-5% of shareholder value])

10 Managing Product Data How are you currently managing your product data? Do you have defined business processes to manage product data? Around 15% of workshop attendees had defined product master data management processes Different roles own different product data attributes, with one person having overall product responsibility Do you have the necessary technology to help manage product data? Around 10% of workshop attendees were supporting master data management processes using technology (mostly spread sheets or ERP) The medical device sector is further ahead in this respect

11 Managing Product Data Change control processes GMP versus non-gmp product Need to clearly define GMP product attributes Data quality management Needed to ensure on-going quality of master data Product Lifecycle Management (PLM) Manages the cradle to grave aspects of product data from drug development to data archiving Product Master Data Management (MDM) used to manage version control product data and structure in one location Federated Product MDM used to automatically propagate applicable product attributes to appropriate business systems

12 Questions / Comments? david.stokes@percipient.co.uk

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