How to Overcome the Challenges of

Managing Global Labeling Updates

Improving quality, compliance and efficiency

Product Recalls Due to

Mislabeling

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When label content is incorrect - whether the label is obsolete, misidentified or incomplete; or the front and back labels of a package are mismatched, products can be subject to costly recalls and reputation-damaging publicity, not to mention human-health risk. For manufacturers in highly regulated industries such as biopharmaceuticals, medical devices, and consumer products, investigating ways to reduce the possibility of a label error is a critical and constant task.

The Cost of Product

Mislabeling and Recalls

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• March 2011, Pfizer voluntarily recalled two of their products which were labeled incorrectly by their subsidiary. Citalopram, a depression drug, was mislabeled as finasteride, a drug used to treat cancer. • February 2011, Qualitest Pharmaceuticals voluntarily recalled hydrocodone bitartrate and acetaminophen tablets for being mislabeled as Phenobarbital. In addition, three lots of hydrocodone were stored in the same inventory where mislabeled bottles of Phenobarbital were found.

When label content is incorrect, whether the label is incomplete, obsolete or misidentified, products can be subject to costly recalls and reputation-damaging publicity, not to mention human-health risk.

Costs of Global Labeling Updates

Are Growing Exponentially

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As organizations expand into new geographical regions, this decentralization can, in many cases, slow down complex processes, reduce operational efficiency and profitability, and delay time-to-market. The ongoing process of maintaining and updating product labels is fraught with costly, error-prone activities. Some of these include:

Manual intervention required to update Local Product Document (LPD) Lack of visibility and controls over the LPD Extensive reviews and proofing All of which adds cost and time…

Cost of Incorrect Product

Label Updates

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In October 2013, Vita Health Products, Inc. voluntarily recalled a variety of health products from the Canadian market because of labeling issues. The recalled products posed a risk to health because the labels contained errors such as suggesting that packages were child resistant when they were not, or were missing warning statements for consumers with allergies or existing medical conditions.

Complexity of Labeling and

Introduction of Errors into the Process

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Anytime human intervention is required for a label update, manual errors may be introduced along with time delays i.e.:

• Interpretation of the update requirements from regulatory authorities or innovator company • Manual update of company core data sheet (CCDS) • Comparison of geo-specific files: may not find and document all required updates

A product label is very specific in its content, especially with respect to safety data and adverse effects. Furthermore, the label needs to comply with country-specific regulations governing the product.

The product label can include multiple documents targeted at various audiences such as patients (leaflets, medication guides, instructions), physicians and pharmacists (package inserts).

Avoiding Costly, Error-Prone

Labeling Processes

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Automating manual, error-prone processes improves • Quality • Compliance • Efficiency • And ensures your products success and brand integrity

SciLabel Pro Engine Automates the

Labeling Process

CCDS Document Parser CCDS Database

Section Selector

LPD

Compare CCDS with

LPD

LPD Pull out Label

Document Auto Publishing Solution

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CCDS: Company Core Data Sheet LPD : Local Product Document

Portal Project Mngt BOM/SKU Reports

DFT Auto 3-Way Compare Auto Label Art Auto Artwork Proofing

SciLabel Pro Workflow Engine

Automation Example Using

SciLabel Pro

1. Auto Change Log Creation

– Change logs for CCDS/LPD documents

– Side by side comparison document

2. Intelligent LPD Creation/Change Mngt

– Auto Generate LPD from approved CCDS

– Intelligently update LPD from updated CCDS

3. Auto Art Proofing/Creation

– Auto proofing of color separated Artwork files

– Auto generation of print ready PIF’s from LPD

4. DFT Rules database

– Rules based packaging label declarations solution

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DFT Rules Module

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End-to-End Labeling Automation

Engine

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Successful organizations require a streamlined workflow management system that includes document management, version control and standardization/synchronization of processes such as labeling and artwork content across geographies.

Results Count

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SciLabel Pro automates the management of updating packaging artwork and labeling literature, while archiving legacy data. It also enables collaboration across geographies and provides near real

time insight into the processes and metrics.

Learn More

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We welcome the opportunity to discuss your unique needs ask@sciformix.com www.sciformix.com

Sciformix: Evolving to Meet Market

and Client Needs