7 Mistakes You're Making with Your Pharmaceutical Package Inserts (and How to Fix Them)

A pharmaceutical package insert has to do more than fit inside a carton. It needs to match the approved content and product version, remain readable when folded, and arrive in the right quantity for packaging. When printing, review, inventory, and fulfillment are treated as separate tasks, small gaps can create avoidable delays and confusion.

Here are seven practical issues for regulatory affairs, quality, and operations teams to watch for, and ways to make the print process easier to manage.

1. Treating artwork versions as interchangeable

“Final” in a filename isn’t a reliable version-control system. Similar inserts may differ by strength, market, language, revision, or product configuration. If teams exchange files through email without clear identification, it can become difficult to confirm which version is ready for production.

A better approach: Use a controlled file-naming and handoff process. Identify the product, strength or configuration, market, language, and revision. Make sure the print-ready file is the one your authorized team has approved, and keep superseded versions out of the active production folder.

The printer can help maintain clarity around received files and production versions. Your regulatory and quality teams remain responsible for approving the content and confirming that it meets applicable requirements.

2. Planning the flat sheet before the finished fold

An insert may look organized on a screen but become difficult to follow when folded. Panel order, fold sequence, finished dimensions, and available space inside the package all affect how the leaflet opens and reads. A layout that hasn’t been checked against the actual fold can place important content awkwardly or make the piece harder to handle.

A better approach: Start with the finished size and folding requirements. Review the number and order of panels, trim, and any areas that need to stay clear of folds or finishing. When the format is complex, ask for a production-style folded sample so your team can review the physical piece, not just the flat artwork.

Starburst produces complex folded IFUs, as well as saddle booklets and perfect-bound books. The right format depends on the content and package; it’s worth discussing the options before the file is finalized.

3. Approving small type only on screen

A PDF can look readable on a large monitor and prove challenging at the final printed size. Dense paragraphs, narrow fonts, low contrast, and text close to folds or edges can make an insert harder to use, especially when the piece is compact.

A better approach: Review the type at actual size, ideally in a physical proof using the intended stock and production approach. Check headings, tables, warnings, symbols, and other detailed elements. If the layout feels crowded, ask whether the format or panel arrangement can be improved rather than simply shrinking the type.

For patient-facing information, clear organization and readability are important considerations. The FDA’s patient labeling resources provide information for teams working with prescription drug labeling. Your regulatory and quality reviewers should determine the appropriate content and requirements for each specific insert.

4. Leaving quantity planning until the last minute

The right insert quantity depends on more than the initial print run. Packaging schedules, production lots, scrap allowances, line requirements, and planned changes can all affect how many pieces are needed, and when they’re needed. If the insert quantity is planned separately from the packaging schedule, teams may face shortages, excess stock, or rushed reorders.

A better approach: Coordinate print quantities with operations and packaging teams early. Confirm expected usage, delivery timing, and how the job should be divided or labeled for use. Revisit the plan when package configurations or schedules change.

Written procedures for labeling materials are addressed in 21 CFR 211.122. How that regulation applies to your operation is a matter for your qualified regulatory and quality teams. A clear quantity and delivery plan can help the people responsible for the work coordinate the print piece with the broader process.

5. Rushing proof review, or treating it as a formality

A proof is a chance to catch production issues before a job moves forward. But when review is rushed, or approval applies only to a screen preview that’s difficult to inspect, details can be missed: panel sequence, an outdated file, small type, or an unexpected change in the printed layout.

A better approach: Agree on who reviews and approves each stage. Give reviewers the approved source and the production proof, and make sure they know exactly which version they’re reviewing. For folded pieces, check the sequence on a folded sample. Keep a record of which file was approved and when.

A print partner can support a clear handoff and help address production questions. Approval of the regulatory content itself belongs with your authorized internal reviewers.

6. Printing more than you can use before the next update

Large quantities may make sense for some projects, but an insert can become outdated if content, packaging, or product details change before the stock is used. Excess inventory may take up space and leave your team deciding what can still be used and what needs to be replaced.

A better approach: Balance unit cost against expected usage and the chance of a revision. For changing documents, shorter digital runs or print-on-demand can help you order closer to need. Review stock before placing a reorder, and make sure teams can distinguish current materials from stock that should no longer be issued.

Starburst offers digital printing and print-on-demand to support flexible runs and document updates. These options don’t replace your organization’s change-control process; they can give you more choices when planning how much to print at a time.

7. Treating fulfillment as someone else’s problem

Even a correctly printed insert can cause a headache if it reaches the wrong destination, arrives in an unsuitable configuration, or isn’t assembled with the other materials needed for a release. When literature packets or staged deliveries are involved, packing and distribution details matter just as much as the printed piece.

A better approach: Include fulfillment needs in the project plan. Confirm delivery destinations, quantities, packaging, and whether inserts need to be combined with other literature. Make sure the instructions for assembling and shipping the materials are clear before production begins.

Starburst’s print fulfillment services include kitting, packaging, and shipping support for literature packets and materials distributed in smaller quantities over time.

Make the handoffs easier to manage

Before the next pharmaceutical package insert project moves forward, check that your team has aligned on:

• The current approved file and revision
• Product, market, language, and configuration details
• Finished dimensions and folding requirements
• Proof format and review responsibilities
• Quantity needs and delivery timing
• How current and superseded inventory will be distinguished
• Any kitting, packaging, or shipping instructions

These are practical production checks, not a substitute for regulatory review. Your regulatory and quality teams remain responsible for content approval and compliance decisions.

If you’re also planning a regulated medical IFU, our article, “Looking for Regulated Medical IFU Printing? Here Are 10 Things You Should Know”, covers related considerations for medical document production.

Starburst Printing & Graphics is ISO 9001 certified, a WBENC-certified women-owned business, and brings more than 36 years of printing experience to complex print projects. If you’re evaluating a new insert, a revised format, or a more flexible inventory plan, tell us about your project. We’ll be glad to discuss the format, run size, and fulfillment options that fit your needs.