Pharmaceutical companies must strike a balance between delivering an effective product to patients and abiding by regulations. Likewise, pharmaceutical packaging manufacturers must also abide by stringent process and quality management guidelines.
Resource Label Group customizes high-quality pharmaceutical packaging solutions while following strict quality management guidelines to manufacture it to exactly match your FDA-approved design. Through our robust ERP system, we are even able to provide with the process documentation information and complete product and raw material chain-of-custody reports the medical industry requires.
Label solutions customized to your specific needs
When it comes to pharmaceutical labels and packaging, there’s no one-size-fits-all solution. From the first consultation, we’ll work with you to analyze your specific needs, and design a process and product around those. Using your FDA-approved design, we’ll craft a label construction with the latest in print, design and inventory management features.
With so many considerations with medical packaging, it’s important to first work with regulatory agencies to verify what needs to be included on your label. After you determine what needs to be included, we’ll work with you design and test a label construction that fulfills all requirements (i.e., tamper-proof features, including pertinent drug and use information, etc.).
Here are some of the features we can incorporate into your fully customized solution:
- Smooth peel labels
- Near field communication (NFC) tags for interactive and tracking capabilities
- Extended content labels (ECLs)
- Piggyback labels
- Security and tamper-proof features
- Warning areas
- Radio-frequency identification (RFID) labels for tracking products
- Micro text, holographic images and specialty foils for anti-counterfeit protection
- QR codes to provide more information online
- Transparent windows
With a full suite of printing and manufacturing capabilities, we can produce any label construction for any product type. Whatever your FDA-approved specs, we can transform them from idea to reality. And through feasibility studies, initial testing and reviewing materials for regulatory compliance, we are not only able to make recommendations, but validate them as well.
Strict adherence to quality management regulations
The only constants in pharmaceutical packaging are the regulations surrounding the manufacturing process. The stringent regulations of the medical industry necessitate a disciplined approach to quality management and documentation during the manufacturing process.
Depending on your specific product’s application, you might need to trace all raw materials from the moment they enter our secure production facility until each product ships, every item uniquely identified for security. We can customize a production process that meets your application’s specific requirements, no matter how specific or complicated.
Having earned all major quality management certifications for the medical sector, we have the capability to construct even the most complex pharmaceutical packaging designs to your exact specifications. And through our robust ERP system, we have the flexibility to configure a process documentation and quality control verification process that aligns with your application’s needs.
Here are the quality standards we adhere to:
- Current Good Manufacturing Principles (cGMPs)
Developed by the Food and Drug Administration (FDA) and mandated by law, cGMPs are the primary regulatory standard for drug manufacturing facilities and processes. cGMPs, if followed, are intended to ensure the repeatability of manufacturing processes and result in the production of safe and effective products, every time.
- International Standards Organization (ISO) 13485
ISO 13485 is another regulation aimed at defining quality management systems in the manufacturing of pharmaceuticals. We’re ISO-13485-certified, meaning our systematic approach to the manufacturing of pharmaceutical packaging has been independently audited and verified. We have the quality management systems in place to manufacture labels precisely to your FDA-approved design.
We’re compliant with all quality management regulations, and can help you successfully navigate the red tape to deliver a successful, compliant end product.
Our commitment to quality management allows us to provide you with your pharmaceutical packaging as specified by your design. It also allows you to trace all raw materials through production, and see a clear chain-of-custody of every individual product we handle through our ERP system’s reports. This not only helps your products pass regulatory review, they can also give you peace of mind that you’re delivering a quality product to the end user—patients.
For comprehensive pharmaceutical packaging solutions made to your exact specifications, work with Resource Label Group. Request a free consultation to start developing a packaging solution today.