SERIALIZATION READY




As a contract packager, Apace has always kept on a watchful eye on horizon as regulations evolve. From Florida Pedigree Papers, to California ePedigree Law, to GDUFA, to current and future DQSA/DSCSA requirements, Apace has proactively met new regulatory requirements. Apace was actively preparing for California’s 2015 ePedigree requirement, with POs already cut to our strategic partners, when the Drug Quality and Security Act (DQSA) was signed into law in November 2013. While many pharmaceutical companies and most contract packagers put the brakes on their serialization solution, Apace made the strategic decision to continue to move forward with implementation. By mid-2014, Apace has implemented its serialization solution on all of its active packaging lines and was actively serializing approximately 25% of its packaging output. By the end of 1Q15, Apace was serializing over 60% of its packaging output.

Apace strongly believes that serialization with aggregation will be the preferred approach for most of our customers. Our solution allows us to turn off any level of aggregation not needed to meet customer requirements. Even though DSCSA only requires item-level serialization, we know that most of our customers, and their customers, will need to be able to receive and manage the serialized data through the practice of inference. For that reason Apace invested in the necessary equipment and processes to allow for the full aggregation of your product. Our bottling lines allow for 4 levels of aggregation and our blister lines allow for 3 levels of aggregation.

Apace complies with GS1 standards including EPCIS and can establish peer-to-peer EDIs to ensure the simple and secure transmission of your data.

Apace has implemented a flexible IT solution with multiple options to help you meet DSCSA Compliance standards. Apace can assign its own serial numbers to your product or we can import serial numbers from your Serial Number Management solution. Apace can also send the serialized data for each batch to you for management, or Apace can hold and maintain your serialized data for future retrieval.

Regardless of your status or approach to DSCSA compliance, Apace Packaging has a flexible solution that can immediately help you with your packaging and serialization needs. Please feel free to contact Customer Service or Sales if you have any questions.


Click here for photos of Serialization.

Click here for video of our Serialized bottling lines.

Click here for video of our Serialized blister lines.

Additionally, if you are not familiar with how serialization works, below you will find a couple videos that provide a brief overview.

Click here for an overview of bottle serialization with full aggregation.

Click here for an overview of carton serialization with full aggregation.