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pharmind: Special Issue 11a/2004 Strategic Pharma Supply Chain Management Enabled by IT-Solutions

Compliant Manufacturing with SAP in the Pharmaceutical Industry

Extending software applications from top floor to shop floor streamlines compliant manufacturing processes for pharmaceutical companies
James Sabogala and Dr. Jrgen Thlkeb
SAP Labs a, Newtown Square, PA (USA), and SAP AGb, Walldorf (Germany)

Today, pharmaceutical companies are at a crossroads. Price discounts, shrinking margins, reductions in market exclusivity, product commoditization as well as Part 11 validation compliance represent new challenges for pharmaceutical companies of all sizes. Equally daunting are pressures on the supply chain. It is not enough to simply deliver the right active ingredient. It must also be delivered on time, in the right amount, at a high level of quality while maintaining a low safety stock and leveraging existing investments in IT and manufacturing. Along with the pharmaceutical industrys changes and challenges come new technologies and methods such as radio frequency identification (RFID), Process Analytical Technology (PAT) and Demand-Driven Supply Networks (DDSN) which will require a strategy to control processes from enterprise resource planning (ERP) down to the shop floor. In the following paper a proposal for such a strategy by using SAP software for compliant manufacturing is described and it is shown how one customer successfully implemented it, cut costs by 10 % and passed a rigorous FDA audit.

Einsatz von SAP-Lsungen fr Compliant Manufacturing in der Pharmaindustrie / Erweiterung von ERP in die Fertigung Pharmaunternehmen stehen vor globalen Marktvernderungen, auf die es angemessen zu reagieren gilt Preis- und Kostendruck, sinkende Margen, rcklufige Marktanteile von Originalprparaten, zunehmende legislative Regularien. Das Qualittsmanagement wird noch wichtiger, die Produktion mu przise an die Nachfrage angepat sein, um unntige Lagerhaltung ebenso zu vermeiden wie zu geringe Bestnde. Neue Regularien wie etwa die Bestimmungen der FDA zur Validierung von Arzneimitteln (Federal Drug Association Part 11 Compliance) oder entsprechende Vorschriften der EU verlangen klar definierte Produktions- und berwachungsprozesse. Neue Technologien und Methoden in der Herstellung wie etwa Radio Frequency Identification (RFID), Prozekontrolle mit analytischen Methoden (PAT) oder bedarfsorientierte Logistiknetzwerke erfordern zustzliche Investitionen.
Der folgende Beitrag erlutert Strategien zur Bewltigung dieser Herausforderungen. Durch die Integration von Geschftslsungen mit fertigungsnahen Anwendungen, einem erweiterten ERP bis zur Fertigungshalle, wird eine umfassende Produktions- und Lieferkettensteuerung in Echtzeit erreicht. Die Integration der Logistikprozesse und die Verwendung von Technologien wie RFID erhhen die Flexibilitt. Pharmahersteller werden dadurch schneller, steigern ihre Agilitt und die Transparenz smtlicher Fertigungsprozesse. Ein Beispiel-Szenario zeigt, wie ein Produzent mit der SAP-Lsung fr Compliant Manufacturing eine Kostensenkung um 10 % und die bereinstimmung mit allen FDARegularien erreicht hat.

Key words

Compliance Pharmaceutical manufacturing Quality SAP Manufacturing Supply Chain Execution

Pharm. Ind. 66, No. 11a, 1405 1412 (2004)

Pharm. Ind. 66, Nr. 11a, 14051412 (2004) ECV Editio Cantor Verlag, Aulendorf (Germany)

Sabogal et al. Compliant manufacturing with SAP


pharmind: Special Issue 11a/2004 Strategic Pharma Supply Chain Management Enabled by IT-Solutions

1. Introduction
A rising number of drug recalls suggests how quality problems have been slipping through the current manufacturing systems. The FDA counts 354 prescription drug recalls in 2002, up from 248 in 2001 and 176 in 1998. [1] The notion of DDSN (Demand-Driven Supply Network) makes sense to practically every supply chain professional who considers it. In pursuing this DDSN model, the first stop for most is improving demand visibility. Participants at the supply chain forum were asked what was most relevant among a broad range of issues: 94 % said demand visibility is extremely relevant or very relevant. [2] These two statements highlight two trends in the pharmaceutical industry: 1) maintaining quality assurance while staying compliant, 2) streamlining the supply chain under increased market pressure. As margins shrink, as generic products gain market share and as the FDA introduces increasingly complex regulations, the industry wants to adopt new technologies in an effort to streamline its supply chain and to reduce production costs.

Fig. 1: Comparison between current state and vision in the IT landscape of pharmaceutical manufacturing.

users to react in a timely manner to issues throughout the supply chain. With proper planning information in place, execution becomes easier and more accurate. With mySAP SCM a detailed plan based on actual constraints can then be quickly executed. Once mySAP ERP generates a planning order, it is converted into a process order and is executed for production. For added efficiency, the necessary data for production are maintained directly in mySAP ERP .

2. Planning and execution: achieving key synergies with a comprehensive solution

How can a software solution support and help the pharmaceutical industry in these areas? The authors would like to sketch a possible answer in this article. The pharmaceutical industry is looking to SAP for solutions in two major areas: planning and execution. In terms of planning, pharmaceutical companies are basically not much different to companies in other industries. Planning functions are supported by the mySAP Supply Chain Management (mySAP SCM). Companies can use it to optimize supply and demand planning at the strategic, tactical and operational levels with a fully integrated, comprehensive range of tools. mySAP SCM not only helps companies anticipate market behavior, but also helps them plan more precisely and work together with supply network partners. Plans and forecasts can be generated to span the entire supply chain, including demand, distribution, production and transportation: they accurately balance material, labor, and equipment constraints with anticipated customer demand; and the combination of supply and demand network planning supports the entire sales and operations planning process. mySAP ERP also plays a vital planning role. In fact, from the moment a customer shipment leaves the dock, mySAP ERP gathers transactional data on inventories, open customer orders and existing production schedules, and feeds it into SAP Advanced Planning & Optimization (APO), a component of mySAP SCM. From there, SAP Event Management and the SAP Inventory Collaboration Hub take over by assembling a single set of coherent data on everything from external events and inventory levels to demand information. It allows

3. Synchronizing planning data

Most companies today leverage enterprise business processes with an integrated ERP system (finance, costing, warehousing, etc.). The last step is often the creation of a process order for collecting costs and material consumption. Unfortunately, these same data are also transferred to a Manufacturing Execution System (MES) via a vast network of interfaces awaiting the confirmations of material consumption and other production data. In fact, the current industry model for MES software actually calls for a set of local, non-standard execution systems with an asynchronous connection to ERP . This creates the need to maintain double master data and reduces insight into manufacturing processes (Fig. 1). In the absence of common production processes, long-term planning clearly becomes more difficult. Hybrid systems are unable to integrate process control systems into ERP supply chains because there is no real-time integration of material tracking and quality management in the first place. Because these software packages have limited exception management and alert handling capabilities, they are only able to offer a limited glimpse inside the production costs and operations of a supply chain. Similarly, stringent health, safety and environmental regulations demand seamless, scalable, customizable software solutions. Without them, each single system must be validated, resulting in sharp increases in validation costs.

4. Achieving seamless, error-free execution

For pharmaceutical companies, a strong connection between data capturing, documentation and review is
Pharm. Ind. 66, Nr. 11a, 14051412 (2004) ECV Editio Cantor Verlag, Aulendorf (Germany)


Sabogal et al. Compliant manufacturing with SAP

pharmind: Special Issue 11a/2004 Strategic Pharma Supply Chain Management Enabled by IT-Solutions

crucial. Stringent process tracking requirements mean that all batch-related data must be consolidated a unique challenge for companies still depending on legacy paper-based systems. This can lead to lengthy batch reviews in extreme cases up to 40 days for a problem in a finished product [3]. Schering-Plough Corp., for example, recalled 59 million asthma inhalers in 1999 and 2000 because an unknown number were shipped out empty. To avoid problems like these and many others, SAP has enhanced its capabilities to control manufacturing processes. Some of these functionalities include: 4.1. Master recipes All production data are set up in the master recipe, including quality inspections and equipment data. They are built out of existing data: bill of materials, material data, and documents from the built-in document management system. Since SAP R/3 Enterprise 4.70, recipe management is included in the standard to build S88 compliant recipes from scratch and to transfer them into operations and phases (Fig. 2). 4.2. Process Instruction (PI) sheet Instead of printing out shop floor papers and capturing data manually, a browser-based process instruction sheet can be generated. Its layout is adaptable to customer needs and its content can vary from a sophisticated set of offerings for management to a more simple layout with a more tailored set of options. The data and the exact procedural sequence are already defined in the master recipe and the transactional data are taken from the process order. The process instruction sheet is sent to defined work center(s) and the worker on the shop floor captures the data by being lead through a simple set of instructions. These manual inputs can then be automatically validated together with the automatic input of near time data. The sequence of steps can be enforced, the completion of phases or operations can be connected to a digital signature and confirmations are automatically generated from the PI sheet. 4.3. Electronic Batch Record (EBR) All relevant data for production are collected in the EBR as well as external documents that can be linked to the EBR. After completion and approval, the EBR is stored in an optical archive and can be reviewed by the QM department or all relevant authorities, including FDA officials during an inspection. To lighten the workload of the QA department and to enable it to focus on more relevant issues, only exceptional cases should be reviewed (Fig. 3). 4.4. Batch management All batch-relevant information can be accessed within the batch information cockpit (Fig. 4), including all data inherited from previous batches (raw material, intermediate products, all quality data, etc.). The following
Pharm. Ind. 66, Nr. 11a, 14051412 (2004) ECV Editio Cantor Verlag, Aulendorf (Germany)

Fig. 2: Information flow in the manufacturing execution area (upper) and setup of master data (execution steps) (lower).

common functionalities are also available: batch number assignment; management of batch-specific data; batch status management; calculation, management and checking of shelf life data; batch determination; proportion quantity management; and derivation of batch data. All data can be used by other applications from the very moment they are posted. This means that

Fig. 3: Example of an electronic batch record, containing all collected data from production including quality inspection data; note: external documents can be attached as well.

Sabogal et al. Compliant manufacturing with SAP


pharmind: Special Issue 11a/2004 Strategic Pharma Supply Chain Management Enabled by IT-Solutions

Fig. 4: Screenshot of the batch information cockpit.

tions. Laboratories, including research and development (R&D) labs, in-process testing labs and quality assurance (QA) labs use LIMS. LIMS facilitates the routine, efficient testing of samples by sorting test information and organizing it into specific report formats to meet regulatory requirements. Simply put, SAP has helped LIMS evolve from isolated data islands to global information platforms, sparking a growing interest in integrated Enterprise LIMS. With a comprehensive, more integrated approach to LIMS and quality management, companies have an opportunity to greatly improve information sharing and to link quality efforts. This will ultimately increase speed, efficiency, and accuracy across the organization. In addition to other traditional LIMS solutions, mySAP PLM offers seamless integration into the supply chain as well as into other key areas within the enterprise. It

all information about the batches is instantly available, be it the stock or the status (available, blocked, restricted use, etc.). The risk of using sub-par material is reduced drastically and, in the worst case, the identification of products produced with such raw or intermediate material is simplified. 4.5. Compliance SAP delivers, as standard, tools that meet the FDA regulation in the area of e-signature and e-records. Throughout the mySAP ERP solution, the term digital signature is referenced in each dialog screen during signature execution and electronic record reporting. All signatures executed within mySAP ERP utilize cryptographic encryption techniques. Therefore, the SAP software defines all signatures as digital signatures (example see Fig. 5). The integrity of the signatures is ensured and unauthorized access prevented by locking the user after a pre-defined number of attempts, an alert to an administrator, for example, via e-mail, the logging of failed attempts and the recording of locking and unlocking. The digital signature can be configured already for, among others, the process instruction sheet, Engineering Change Management (ECM), EBR approval, results recording, usage decision, physical sample drawing and status change in the document management solution (DMS). With SAP R/3 Enterprise 4.70, an encapsulated signature tool enables the modificationfree inclusion of additional signatures in all SAP components. This means that throughout the manufacturing process, these tools can also be used to enforce the FDA regulation. This includes an audit trail and a change management tool (ECM) to track and restrict changes in GxP critical areas. 4.6. Quality management Quality management capabilities in mySAP Product Lifecycle Management (mySAP PLM) enable a company to establish an enterprise-wide laboratory information management system (LIMS) with comprehensive functionality to plan, perform and report on quality inspec-

provides a standard platform for integrating quality management processes across the enterprise, enables visibility of quality data throughout the organization, enhances communication between quality groups and other departments.

According to a German LIMS journal [4], LIMS should support the full range of laboratory processes and should include core functions such as

master data maintenance, inspection plan management (specification, characteristics), order management (work scheduling, status tracking, quality costs), results recording (including validation, plausibility and specification checks), release (inspection results, samples, batches),

Fig. 5: Example of a digital signature displayed as pop up, for example, when signing a process step in the process instruction sheet. Note: a signature strategy is applied, meaning that two persons have to sign. This can be configured to be synchronously (both must sign concurrently) or asynchronously (second signer can execute signature later).


Sabogal et al. Compliant manufacturing with SAP

Pharm. Ind. 66, Nr. 11a, 14051412 (2004) ECV Editio Cantor Verlag, Aulendorf (Germany)

pharmind: Special Issue 11a/2004 Strategic Pharma Supply Chain Management Enabled by IT-Solutions

Fig. 6: Key capabilities of quality management within mySAP ERP integrated in relevant business processes and leveraging all functionalities of an LIMS.

laboratory statistics (Certificates of Analysis (CoA), Statistical Process Control (SPC), Key Performance Indicators (KPIs)), data retrieval and archiving, work lists and workflow.

4.7. Taking quality management one step further In addition to these key features, quality management with mySAP PLM also supports various types of laboratories, including industrial and commercial (Fig. 6). Industrial laboratories are typically found within a company and focus on analyzing raw materials, semi-finished products and finished products. They are one of most if not the most important organizations for ensuring product quality for in- and post-process production control, batch determination and issuing Certificate of Analysis (CoA) in sales and distribution. The master data for all these inspections and approvals are maintained in one centrally located system. Problem processes can also be predefined and integrated into all processes by using so-called notifications coupled with a workflow. Some key processes should be sketched here. 4.7.1. Stability studies Shelf-life studies provide a means of testing and evaluating products during various stages of the product life cycle. A stability study documents a request to examine and test a substance or product over a specified period of time, and to examine the effects of different storage conditions on the characteristics of this substance or product. A stability study is usually conducted over an extended period of time to determine the long-term effects of these conditions. The stability study is represented in the system with the help of a quality notification. The quality notification is the business object that is used to process and manage all of the activities that relate to a stability study.
Pharm. Ind. 66, Nr. 11a, 14051412 (2004) ECV Editio Cantor Verlag, Aulendorf (Germany)

When various process steps in a stability study are executed, the system can automatically assign the following additional objects to the study, depending on which steps are performed: 1) Initial sample 2) Documents 3) Stability bill-of-material 4) Inspection lots for initial test and stability tests 5) Stability samples for storage conditions 6) Testing schedule The system automatically generates all necessary objects to perform inspections on the scheduled dates. All information gathered during these inspections are part of the stability study; they can be reviewed for approval and are locked after completion. 4.7.2. Incoming inspections When procuring raw materials, the purchasing department has to select vendors that have received a positive evaluation in terms of price, reliability, and quality. With SAP, it can issue technical delivery terms or quality assurance agreements on the purchase order and automatically initiate inspections on the goods receipt. After sample drawing and completion, the material can be released, blocked for the rest of the production process or sent back to the vendor with a complaint. The processing of purchase orders and invoice receipts can also be blocked. Finally, because it is integrated in inventory management, the usage decision is automatically visible and prevents the usage of defective material. 4.7.3. Inspections during production In process industries, recipes are used to control production execution. Quality assurance is seen as part of execution and can be directly planned during the recipe creation. All activities can be included in the recipe and an in-process inspection can be automatically triggered when a production order is released as well as the usage of statistical process control for certain test equipment. The costs of inspection activities and

Sabogal et al. Compliant manufacturing with SAP


pharmind: Special Issue 11a/2004 Strategic Pharma Supply Chain Management Enabled by IT-Solutions

Fig. 7: Manufacturing architecture of SAP software.

quantities can be confirmed when recording the results to calculated production costs. 4.7.4. Sales and distribution Products are selected according to their suitability for various customers through a process know as batch determination (e.g. purity, content of water or only batches that meet the regulatory requirements of target market countries). Either the existing inspection results are sufficient for that batch determination or an inspection can be triggered automatically upon delivery. 4.8. Plant maintenance All equipment can be maintained within the mySAP Enterprise Asset Management. To ensure that all machinery or necessary equipment is available for production, maintenance intervals are kept. This information can be accessed and changed from production (for example, equipment checkout of the PI sheet) meaning that no equipment is used that is currently in inspection or pending cleaning. Fig. 7 illustrates the integrative architecture of the SAP Manufacturing solution that gives the highest return on investment (ROI) for a central solution. With the comprehensive, flexible technology platform, SAP NetWeaver, decentralized scenarios can also be implemented. Levels 4 and 3 can be modeled with solutions of the mySAP ERP and mySAP SCM. The connection to levels 2 and 1 can be achieved through standard interfaces (PI-PCS, SAP ODA, ISA 95 adapter, etc.)

MES systems do not really handle real time control with guaranteed response times. SAP, however, has already taken important steps toward direct communication at the automation level, with near time response in the millisecond range. Coming from a proprietary, asynchronous, message-based interface (PI-PCS), SAP has also supported the OPC (Object link exchange for Process Control) standard since R/3 4.6C to synchronously exchange data with shop floor devices in the millisecond range (Data Access, Alarms and Events). The OPC standard enables SAP to receive Alarms and Events notifications and to react in a timely manner to unforeseen events on the shop floor. The open architecture of SAP NetWeaver has gone one step further in integrating legacy systems and in making information available to different roles. The ANSI/ISA-95 standard enables the communication between ERP and the shop floor by defining message types. The WBF (World Batch Forum, Longwood, FL, USA) has defined B2MML (Business To Manufacturing Markup Language) schemas for these messages and SAP will support this standard to make it easier for customers to connect existing systems and exchange control and process data.

6. Getting the right data to the right people

Who needs all of these data from the shop floor? SAP has identified two roles in the plant: the plant manager and the shop floor supervisor. Both need actual information from the shop floor and KPI reports for comparison with planned data (e.g. capacity utilization). Flexible views on relevant data of several sources, alerts and events enable the plant manager to control production lines and even shift production schedules if necessary. Fig. 8 shows an example of a dashboard that is delivered with the mySAP ERP 2004. Because the role of the shop floor supervisor is different, a specially designed shop floor version is currently under development.
Pharm. Ind. 66, Nr. 11a, 14051412 (2004) ECV Editio Cantor Verlag, Aulendorf (Germany)

5. Automation: making it a visible part of the supply chain

When it comes to making manufacturing more visible in the supply chain, one level is consistently difficult: the automation level. ERP systems as well as other


Sabogal et al. Compliant manufacturing with SAP

pharmind: Special Issue 11a/2004 Strategic Pharma Supply Chain Management Enabled by IT-Solutions

7. From development to production

SAP delivers several tools to support the NPDI process (New Product Development and Introduction; see also in general: SAP xApps composite applications for resource portfolio management and product definition, as well as for the pharmaceutical industry in particular. The authors have already mentioned quality planning (for example, stability studies, inspection plans and procedures) and recipe management, enabling customers to develop new recipes without any predefinition of master data. In an iterative cycle, these recipes are enhanced and the master data can be generated out of this draft recipe. Other examples are research and development administration or clinical trial and supply management (CTSM). The latter supports the product launch in the pharmaceutical world by effective management of clinical trials and thus helps to reduce the clinical trial supply cycle time by 40 to 70 % and reduces excess inventory by 5 % to 25 %. CTSM begins with the planning of the clinical supplies up to two years, rather than a mere 12 weeks. It then focuses on getting clinical trial material produced, labeled, packaged and delivered on time and to the correct sites. Visibility of the supply chain from raw materials to final delivery is key for accurate planning and forecasting. CTSM enables a flexible manufacturing strategy and supports both make-to-stock and maketo-order scenarios. Also here, the integration of existing data and business processes is one of the key advantages. The supplier relationships already exist and one can rely on qualified suppliers. All recipes are already created and the inventory and shelf life control is managed with mySAP ERP. Other important factors in fulfillment are blinded labeling, compliance to shipping and transportation regulations and proof of delivery for seamless tracking of all samples.

Fig. 8: Example of a plant managers Manufacturing Intelligence Dashboard running in an enterprise portal.

9. Controlling manufacturing processes: a case study

With its SAP-based compliant manufacturing solution, Japan-based Daiichi Pharmaceutical Company (Tokyo, Japan) has successfully completed the validation process required by the FDA for its computerized systems. In doing so, it has increased efficiency across its entire production process. Founded in Tokyo in 1915, Daiichi operates 14 consolidated companies in Japan and 14 international sites achieving yearly revenues of 3.1 billion US-$, and 500 million US-$ in pre-tax profits. As a globally operating producer of prescription medicines, one of the companys core markets is the United States. According to FDA regulations (referred to as CFR Part 11) any drug manufacturer selling in the US market must validate the use of computerized systems through the documentation of their business processes. Businesses are subject to on-site inspections (audits) by the FDA. Recognized around the world, CFR Part 11 sets clearly defined rules covering all aspects of operations, from quality control of manufacturing processes and comprehensive document management to personal identification through secure user log-ins and digital signatures. Bottlenecked by an obsolete legacy system (a partially automated host system giving general instructions for manual processes) Daiichi s operations were plagued with a general lack of standards across the various international and local offices. Significant information gaps existed among internal departments, and material balance data had to be inputted to the host system manually for financial operations. The system led to excessive inventory, slow business processes for reconciling finished products, limited availability of data records and insufficient batch records for Quality Assurance (QA). QA review consisted of a manual check of stacks of sheets to compare the results against set values for the QA process. According to the general manager, the company had experienced extremely long cycle times due to recon-

8. Enabling new technologies with SAP NetWeaver

The SAP NetWeaver platform is also open for new developments and technologies such as RFID. At the moment, companies are utilizing RFID technology as a simplified bar code reading to meet the requirements of large retailers such as Wal-Mart. But the real benefit of RFID technology especially for the pharmaceutical industry will be achieved by implementing it throughout the supply chain. Data from the production of raw materials can be inherited via the RFID tags. This pedigree tracking can, in turn, prevent the counterfeit and misuse of drugs. RFID will be therefore supported by the FDA, and Fig. 9 shows the architecture of the SAP offering. It is the first RFID usage scenario currently being implemented by Purdue Pharma LP , Connecticut [5]. But this is only the first step SAP is taking to enable companies to reap the benefits of RFID. The technical infrastructure to connect any SAP system with RFID readers is available. The flexibility of the SAP NetWeaver platform will enable the next steps to implement a holistic approach to the supply chain by leveraging the newest technologies.
Pharm. Ind. 66, Nr. 11a, 14051412 (2004) ECV Editio Cantor Verlag, Aulendorf (Germany)

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pharmind: Special Issue 11a/2004 Strategic Pharma Supply Chain Management Enabled by IT-Solutions

Fig. 9: Architecture of SAP solutions for RFID. SAP Auto-ID Infrastructure connects the RFID controllers to software applications via the SAP NetWeaver component SAP Exchange Infrastructure. The solutions shaded in light-blue are offered by SAP.

ciliation of lot data; in using paper records, they still had to be able to search and identify key information in storage. The problems with paper records were the need to check a lot of paper sheets and data during QA review and the physical limitation of data volume in paper. There was also the problem of reliability of records which carried no time stamp, change history or logging information. Daiichi thus undertook a business process re-engineering project, using SAP solutions to establish and execute manufacturing and QA processes based upon global Good Manufacturing Practices (GMP). The company rolled out the manufacturing system from SAP to standardize and reinforce business processes globally, eliminating local rules for individual plants. The manufacturing system has accelerated business processes by standardizing and integrating manufacturing, QA management, supply chain management and enterprise resource planning (ERP). Daiichi sharply reduced production lead time, raw material inventories and semi-finished product inventories, creating a consistent, computerized process flow which includes 1) weighing and container control, 2) operation instructions and records, 3) batch control and records, and 4) electronic signatures. The company has been able to reduce average time for manufacturing and releasing products; by using SAP across the business processes, finished products can now be released 10 % faster than with the old system of paper-based records from manufacturing to batch record review. SAPs integrated manufacturing and QA management solution chronologically implements enriched electronic batch records to reinforce QA review, links to the ERP software and eliminates bottlenecks caused by redundant data management. The general manager also emphasized that there are no interfaces, time lags and data inconsistencies when data are pooled from the shop floor into SAPs production planning for manufacturing systems and that the company is also able to build on its investment in its SAP competency center for both ERP and manufacturing operations.

Daiichis Akita plant was visited by the FDA in February 2004, receiving an excellent and perfect evaluation on validation policy, plan and documents. No 483s were issued and only 3 minor recommendations were cited. SAP rollouts for the other domestic plants of Osaka and Shizuoka are planned for 2005.

10. Conclusion
The usage of SAP for manufacturing processes enables visibility of data from the planning department to the shop floor. A consolidated data base with actual data helps companies make faster and more reliable decisions. Pharmaceutical companies can rely on proven functionalities that make GXP regulation compliance, data capture and reporting easier and more efficient. Among the many benefits of using SAPs integrated software solutions are validation cost savings from harmonized processes, master data maintenance, easier and consistent review of batch data and faster reaction to alarms and events.

11. References
[1] Abboud, L., Hensley, S., New Prescription For Drug Makers: Update the Plants, Wall Street Journal, Sept. 3, 2003, online version: [2] OMarah, K., Preslan, L., Demand Visibility Is Supply Chain Managers Top Problem, AMR Research. The Alert on Consumer Products and Life Sciences, July 15, 2004 [3] Roderick Martin, Vice President Research Process, Consumer Products and Life Sciences, AMR Research, personal communication, New York, Jan. 19, 2004 [4] Grunwald, P ., BioTechnica 97 From Science to Business, Nachr. Chem. Tech. Lab 46, 20 (1998) [5] SAP Drives RFID Adoption, SAP INFO May 13, 2004, SAP AG, Walldorf; online version:

Correspondence: Dr. Jrgen Thlke, SAP AG, Neurottstr. 16, 69190 Walldorf (Germany), e-mail:
Pharm. Ind. 66, Nr. 11a, 14051412 (2004) ECV Editio Cantor Verlag, Aulendorf (Germany)


Sabogal et al. Compliant manufacturing with SAP