The right chemistry for success

The pharmaceutical industry is facing major challenges. To be successful in a client-oriented and highly regulated marketplace, companies need IT partners that can redesign business processes to help reduce costs and increase efficiency.

Significant challenges lie ahead for the pharmaceutical industry. Change is inevitable in the next few years as companies try to cut costs, reduce time to market and collaborate more effectively for agility and speed. Furthermore, the volume of illegal trade in counterfeit drugs worldwide is expected to be worth $75 million by 2010,
a 90% increase from 2005.

As globalisation advances and the competitive environment becomes tougher, the chemical and pharmaceutical industries will be looking for ways to streamline their business processes. To be successful in the customer-focused, tightly regulated marketplace of the future, pharma needs partners that can reduce costs through technology integration and redesign business processes in the drive for speed,
agility, risk reduction and assured compliance.

Outsourcing solution
Many core applications and platforms in pharma have been developed in-house to deal with highly specific needs. The result is great complexity, making IT standardisation a major challenge. IT service providers such as Siemens IT Solutions and Services help to rationalise the IT infrastructure to cut out duplication, introduce common standards and make IT processes more agile and responsive to business needs. Applications are managed across the business to ensure better levels of integration, while simplifying the infrastructure. Moreover, IT outsourcing can free up capital for productive investment, while embedding constant innovation into corporate systems. Siemens’ manufacturing heritage gives it special insights into ‘shop-floor IT’, which is essential in outsourcing and harmonisation within the pharmaceutical sector.

	Serialization for ePedigree applications provide effective protection against product piracy and counterfeiting.

Although IT harmonisation is a key factor in cost and efficiency gains, process design is at the heart of winning strategies for competitive advantage. Siemens IT Solutions and Services has developed systems that respond to companies’ global dynamics and related requirements.

Unique identification
Around 10% of all drugs worldwide are counterfeit and this is an increasing trend. This also illustrates a World Health Organization study that shows every year, counterfeit drugs cost thousands of lives, resulting in substantial financial costs for the legal industry.

One way to protect against counterfeit products is Siemens’ Serialization for ePedigree, which provides drugs with a number and documentation so that each product is uniquely identifiable. California is leading the way as far as the Serialization for ePedigree is concerned. US law is expected to require every product to have a unique number from 2015. The same statutory requirement has existed in Turkey since 2009 and is planned in the EU for 2011, if the European Federation of Pharmaceutical Industries and Associations has its way.

Serialization for ePedigree is a great challenge for the pharmaceutical industry: billions of unique serial numbers will have to be generated, printed on billions of packages and each item’s history will have to be stored. Today’s packaging lines manage eight packages a second, but pharmaceutical manufacturers are already planning to increase that to 12 packages a second. During this time, the packages have to be serialised, which means they need to be printed by a high-speed printer, organised hierarchically and the data stored. Such challenges place high demands on the IT landscape in terms of load and security – demands that can hardly be met by existing systems in the pharmaceutical industry alone. To handle and store this glut of data, high-performance, fail-safe systems are needed that fulfil the requirements of the industry, for example, all systems used must be validated according to good manufacturing practice or USFDA guidelines.

Systems integration
Generally, manufacturers have validated systems for handling the packaging lines. Independent serialisation systems have to be connected to these in a way that does not require them to be revalidated in their entirety. In addition, the link between ERP and production systems is still provided by manually entering the ERP terms
at the production plant.

In order to link these two worlds through IT, huge volumes of data must be compared and interfaces implemented. Therefore, the challenge is to implement a global architecture on all levels that most companies do not yet have.

First, a comprehensive Serialization for ePedigree solution will enable pharmaceutical manufacturers to meet the more stringent statutory requirements that are on the horizon, while keeping costs and effort to a minimum. Proof of origin provides effective protection against counterfeit products and so ensures greater revenue. In addition, it brings a previously unknown level of transparency to the production process and sequence, distribution channels and the life of a pharmaceutical product until it is in the hands of the consumer. At a time when development cycles are increasingly short and product variety is greater, this is important information.

Single-source solutions
To integrate serialisation solutions smoothly into existing systems, many large pharma use external IT service providers. Merck Serono is to use the Serialization for ePedigree solution for its manufacturing events.

Siemens IT Solutions and Services is the only provider that offers all the solutions and services required – including consulting, components, rollout, maintenance, data management and operation – from a single source. Serialization for ePedigree automates all processes from the packaging line to integration into the ERP landscape.

The components included in a particular solution depend on the needs of the individual customer. Siemens IT Solutions and Services offers its features for the serialisation process on five different levels:

1. Hardware and its implementation.
   
2. PLC for managing the automation of the packaging line.
   
3. Software for managing data at the production plant.
   
4. Software for managing the data centrally (for example, SAP AII and OER integration), at the IT service provider.
   
5. The link to trading partners.

	High safety standards are crucial for the chemical and pharmaceutical industries.

Transparent movements
As well as security demands, pharmaceutical industries are subject to a plethora of rules and regulations. Companies must comply with many different transportation guidelines, safety standards and regulations, with new ones being added all the time.

To meet these challenges and to track and trace the many containers and conveyances used along the entire supply chain, RFID technology is another option. It can deliver real-time data about the condition of containers and transmit information about their position to the customer. As a result, the supply chain becomes more efficient and more trouble-resistant – and ultimately more secure.

For a seamless tracking and tracing system, companies must have a standardised technical infrastructure with transponders, as well as read/write devices along the entire supply chain, involving many different partners. In addition, the data and systems must be efficiently integrated on the IT level. Many small and medium-sized companies lack the financial and personnel resources for such an endeavour.

For this market and for the increasingly international supply chains in the chemical and pharmaceutical industries, Siemens IT Solutions and Services offers RFID operating models as a full service provider with flexible service and billing features. Customers can now get a complete RFID infrastructure with comprehensive automatic identification services that meet their specific requirements and respond to global dynamics.