Managing packaging specifications can be a tedious process, especially in highly regulated companies. Being part of the pharmaceutical industry requires careful management of thousands of complex specifications and strict adherence to many government regulations. Luckily, a validated Specification Management System (SMS) can make these processes much more efficient and alleviate many of the pain points associated with managing specifications in a regulated environment. This article will discuss four reasons why every pharmaceutical company should move their packaging specs into a validated specification management system in order to simplify the regulatory process and reduce time-to-market.
1. Reduce Packaging Error Rates and Recalls
Due to the heavy regulations placed on the pharmaceutical industry, the information printed on each bottle, tube, vial, syringe or carton and the primary and secondary packaging components of products are strictly monitored. One small error could mean costly losses and huge blows to a company’s delicate reputation. Using a packaging specification management system to manage your specifications, these packaging mistakes and recalls can be greatly reduced. In the event that an error did occur, perhaps identified during manufacturing, it would only take minutes to search and identify the full scope of specifications, SKUs, and suppliers impacted.
Spec management systems offer version control features that help to ensure employees are working from the correct version of a spec. Version control is a method of tracking updates/enhancements to specifications and files as well as always knowing which version is current or effective. When you have multiple packaging engineers revising specs and no streamlined way to control versions, the risk of working from the wrong file and causing a packaging error is likely. Version control and related notifications/security controls, assures that all stakeholders can be certain the data they are looking at is accurate when specs are being edited and distributed. Version control enables you to:
- Track and manage the changes made to each document
- Ensure that content cannot be accessed by unauthorized users
- Get notifications if there are pending updates that are awaiting approval
- View the most current content and know who reviewed/approved it and when
- Respond to external audits with detailed audit reports across all versions
Even further, a spec management system can improve visibility across your supply chain and reduce instances of packaging recalls. Visibility is the basis for better and more comprehensive decision-making as it enables companies to avoid disruptive bottlenecks and unnecessary packaging errors. Establishing one place for managing your specifications and other packaging documents gives you the power to create reports from your data that inform critical business decision makers. These systems transform your processes by allowing you to organize parent bill of materials (BOMs), view Where Used across your product line, manage suppliers, and automate your review and approval method. Your supply chain becomes more transparent and communication flows easier from beginning to end.
2. Adhere to Regulatory Requirements
In order to follow industry standards, pharmaceutical products need to be stored, filled, sealed, and labeled under precise conditions that ensure the product’s integrity. This means that even one small complication along the product pipeline could land your company costly regulatory fines. However, with the use of a specification management software, packaging professionals can rest assured these regulatory requirements are met. These systems allow you to create your own electronic forms where you can structure data, control inputs, and easily align your different departments on standards to ensure quality and compliance. In addition, a validated spec system guarantees your organization will respond with confidence to any regulatory body in an audit.
Traceability is another critical piece of the quality puzzle for packaging professionals grappling with regulatory compliance and GMP standards. A spec management system enables full traceability across your product lines, creating a single source of truth within your document pipeline. You can easily track who oversees a spec, where it is in its lifecycle, who’s accessed it, who’s printed it, and who is responsible for maintaining and seeing it move into production. It can also help to guarantee that the highest quality business processes are being followed to ensure you are meeting regulatory requirements.
As the pharmaceutical industry looks to the future of regulatory trends, increasing sustainability will also be part of the conversation. As stated in a recent study conducted by Honeywell, “The future of drug packaging will see a shift towards more sustainable materials… Related guidelines are set to take effect in 2025. The guidelines pertain to corporate responsibility and state that consumer product packaging should be recyclable to help offset rising pollution levels.” Moving your specs into a system with a traceable product pipeline makes sustainability simple. A centralized system allows you to view where used, create reports on material use, and collaborate with suppliers on material substitutions more quickly and efficiently. Sustainability is the wave of the future and with a spec management system, your company can be ahead of the trend.
3. Launch New Products Faster and Easier
In the pharmaceutical industry, increasing speed to market is an ongoing goal which is often hindered by inefficient processes and regulatory red tape. By automating the workflow of key business processes, you can increase process efficiency and significantly reduce the time and resources needed for regulatory compliance activities. When you use an SMS, employees no longer have to complete tedious, time-consuming tasks and the frustrations of not being able to find information quickly disappear. Efficiencies gained when using an SMS include:
- Easily search for common traits among your products and locate where components are used in your product line
- Replicate similar specifications to avoid manual data input, making the creation of similar specs take minutes instead of hours
- Manage R&D and commercial specs in the same system, allowing approved R&D specs to be converted to commercial production when applicable
- Link to related documents such as artwork, technical drawings, die lines, work instructions, packaging instructions, raw materials and unlimited file types to create BOMs
- Automate email notifications to suppliers and stakeholders when specs and docs become effective or need review and approval
- Easily create BOMs and Finished Goods and manage both component qty/units AND packaging information (palletization, master data, etc.) all in one specification
- Add critical attributes to specs for identifying customers, locations and quantities
- Produce reports with attachments and subordinate specs/references/drawings and configure reports for different audiences
4. Improve Collaboration Throughout Your Supply Chain
A specification management system is a perfect tool for improving your company’s collaboration, both internally and throughout your supply chain. An SMS allows employees, stakeholders and suppliers access to necessary spec data in a secure and controlled way from anywhere, anytime. Automated notifications to employees, suppliers, and CMOs when specs become effective ensure that all stakeholders are on the same page. Employees can easily make changes that will update throughout your product line and automatically notify suppliers and CMOs of the changes. A centralized spec system stimulates a more efficient collaboration process to ensure your supply chain is adequately connected.
If you are looking for an organization to help you improve your pharmaceutical packaging specification management process, DocXellent can help. We are glad to advise you on how you can accomplish your goals and demonstrate how our packaging specification management software, ENSUR, can maximize your company’s efficiency. Contact us today.