Complying with Regulations

Information technology systems need to include packaging and other functions to ensure such compliance.


Mike Haldane, 
3M Industrial Services and Solutions Division

Mike Haldane

For most pharmaceutical companies, staying in compliance with regulatory agencies, such as FDA, is extremely difficult. To complicate matters further, manufacturers are faced with supplier, customer, and internal regulations. Finally, compliance affects nearly every level of 

a life sciences organization, with requirements related to raw materials and analytical research, branding, computer control systems, equipment, and documentation. Despite the complexities, most companies, even large ones, do not have IT systems that can support multiple, constantly changing, internal and external requirements.

Compliance is also often hard to guarantee throughout the supply chain. Pharmaceutical companies that send product in bulk to a number of contract packagers or repackagers to be measured and placed into retail packaging and transport packaging, and then to mass-merchandiser distribution centers, potentially lose control of their processes. If these third parties do not adhere to manufacturer re-quirements, manufacturers could face regulatory and customer fines, violations of company branding or other policies, and environmental restrictions or consumer litigation.

And an FDA-issued noncompliance fine can cost hundreds of millions of dollars. Common infractions include inadequate processes, missing archives, mislabeling, and other packaging-related issues. FDA also posts the names of violators on its Web site (, publicly announcing fines that exceed $500 million.

Corporate brand standards can also be difficult to manage when production and design take place outside the company. Pharmaceutical products, both drugs and devices, are often produced in locations around the world. As contract manufacturing and global sourcing become more prevalent, coordinating multiple time zones, languages, and cultural barriers will make complying with established branding policies even more complex. Purchasers sometimes fine manufacturers for noncompliant packaging. Examples of violations include bar codes that won�t scan, improper label placement, and failure to use approved brand templates. These violations could result in a financial loss or terminated contracts. 

Without a central, automated system to manage the packaging process and enforce company and regulatory rules, the risk of human error and the potential for using incorrect or outdated information is high. The solution is a data-enabled, integrated packaging management system that brings disparate systems together, enables global collaboration both internally and externally, enforces critical business and regulatory rules, and maintains a fully reportable archive of packaging data.

A password-secured, Web-based, data-driven system focused on packaging operations can be used to effectively manage compliance. With this type of system in place, multiple parties, both inside and outside of a given company, can collaborate in a real-time environment in a safe and secure manner. With an integrated enterprise perspective, companies can best deal with the many complexities of packaging compliance. 

To this end, some companies have adopted enterprise resource planning (ERP) systems. But many of these IT systems are disconnected from artwork creation systems. These, in turn, are disconnected from specification management systems, which are again disconnected from packaging execution systems. Even worse, many companies have not digitized their package information or are still using paper files to archive packaging specifications, regulatory information, and artwork. Even at many of the most innovative companies, document management systems are still being used to manage packaging, as opposed to integrated, data-enabled packaging systems.

Any IT system intended to enable compliance must feature the following specific attributes:

� A central repository for packaging data. Multiple users (internal and external) should have secure access to a common set of packaging-related artwork, templates, text, and translations from a Web-based, data-enabled tool, built with the flexibility to enforce business rules that enable compliance. 
� Robust security. A dynamic, role-based security model requires each user to log in, and then issues rights based upon function within a given company.
� Business rule based. Product identifiers like product numbers and SKUs should be associated to specific templates, which are then associated to specific data and graphical elements, ensuring accurate information is in the proper format for the purpose at the right time.
� eWorkflow. An automated process should send packaging data to predefined stakeholders, such as package engineering, regulatory, legal, marketing, and production professionals simultaneously, ensuring streamlined approval.
� Reportable archives. A full audit trail of all packaging activities should be stored by the system and be fully reportable. 
� Unicode support. Effective communication among all suppliers, contractors, and customers around the world should be facilitated with a multilingual application interface.

The complexities of pharmaceutical packaging compliance are well documented, as are the consequences of noncompliance. Focusing on compliance could save companies millions of dollars. With multiple factors emerging, including time-to-market pressures, global competition, and increased regulation, new data-enabled packaging systems will surely prove their worth.   

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