QUESTION 1

HAVE YOU IDENTIFIED YOUR LABEL CONTENT?

Invent your label one time. The need for a new label should not be the kick-off for a new label creation commission with meetings, personalities, deep dives and lessons learned. If you haven’t already done it, decide what label elements you are going to require on your label and record that in a policy/standard/specification (whatever fits your system). Include the source requirements for your decisions. Make this decision with an eye towards regulatory compliance. Unless your product is marketed to consumers, aside from you company’s logo, keep the marketing off the label. Once you have this, you’re done. Resist the call to add extraneous elements to your label. If you are open to reinventing your label each time you look at it, your label process is doomed to fail.

QUESTION 2

HAVE YOU ESTABLISHED SPECIFIC OWNERS OF LABEL CONTENT ELEMENTS?

Once you’ve established which elements must be considered for inclusion on your label, make sure the appropriate person/department is responsible for providing that information. To do this, you need to codify the roles and responsibilities for providing these label elements. Ideally Product Development and Regulatory Affairs should be the primary information providers as they should “own” the majority of the label elements. Legal may own trademarks, Brand/Marketing will likely own the brand name, company logo and any specific colors; make sure roles are not shared. You want to create a system that allows for accurate information gathering that is entirely objective in nature.

QUESTION 3

HAVE YOU CREATED A PROCEDURE FOR COLLECTING LABEL DATA, DEVELOPING LABELS AND APPROVING LABELS?

Your label development procedure starts with label content intake. If it isn’t as specific and straightforward as the preceding paragraphs, you’re not ready to implement this procedure. This process will require a lot of decision making at the formatting level, but only for how to fit the content on the available label space, never what the content needs to be on the label. Once the label is formatted, the process will confirm that the label prints correctly on production printers. After this, use change control to approve this label by the content owners. Once approved, the label should be “transferred” to production. This label, like the device, is now in the hands of Operation. Responsibility for getting a legible label that meets the specification, on the right package now belongs to Operations.

QUESTION 4

HAVE YOU CREATED A PROCEDURE FOR ISSUING LABELS IN OPERATIONS AND SUPPLY CHAIN?

Operations now needs to have a process that controls the printing, verification, control and tracking of labeling. Once printed in the production environment, the label must be verified for legibility and confirmed that it meets the label specification. Label stock will undergo incoming receiving and be stored in a way that minimizes potential mix-ups. The application of printed labels should never start before a verifiable line clearance has taken place. Label reconciliation must be done before the labeling process can be considered complete. Recording of the label stock lot number, the reconciliation and the attestation of the verification must be recorded in your DHR. The requirements of production printing of labels are the same at manufacture, third party packaging and delayed labeling. The procedures at each location should be very similar.

QUESTION 5

DO YOU HAVE A SYSTEM THAT CAN MANAGE THE LABEL DATA IN A WAY THAT SUPPORTS THE BUSINESS NEEDS?

Lastly, your label system should meet your business needs. Since labeling is considered part of the device, your label process must be validated. This is best accomplished with a validated labeling solution. A system like this can be a repository for the latest approved version of the label, which can serve as your label specifications. With a validated workflow inside the label system, you can leverage this with your change control system to streamline the approval process and significantly reduce the time it takes to approve labels. If your system has the capability, you can use it to store and control your IFU content and your packaging artwork, meaning you can control all your labeling in a single system. In a validated system, you can eliminate the need to control label content with Bills of Material. Lastly, with the right system, you can port its capabilities to contract manufacturers or Country Specific Labeling printing processes in your Distribution Centers. These components of your labeling system build upon each other. If you don’t optimize each step, the subsequent step will be compromised, and your efficiencies will suffer. If you have the wherewithal, you can build a labeling process that will produce a label for workflow approval in one day, virtually eliminating label content errors and be manageable with just a handful of Super Users.