Packaging & Artwork Solutions for Pharma

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Packaging & Artwork Management Solution for Lifesciences

Across the pharmaceutical industry landscape, labeling is increasingly recognized as a mission-critical process that helps further an organization’s strategic goals. Frequent label changes are a matter of course and new regulations emerge with increasing frequency.

So, it makes sense to use a robust artwork management system which can address inconsistencies in processes, mitigate human errors, enhance label quality and improve business agility. Below are various aspects of Pharma packaging and labeling that relate specifically to Pharma and how ManageArtworks addresses these scenarios.

Artwork Lifecycle

The label lifecycle in the pharma industry typically starts with the regulatory submission label. Once the regulatory approval is received, the commercial label is developed and released. The corresponding print proofs are reviewed and approved before printed labels are delivered to the plant

While the drug is in the market, it goes through numerous changes driven by regulatory or brand needs. Eventually, the drug is taken off the market and the excess packaging along with print plates are destroyed

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Artwork Lifecycle

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Packaging ‘parts’ and ‘components’

Pharma products come in numerous SKUs. Different doses for the same brand are considered different products, and different sizes for the same product are considered different packages. Each different product or package requires different text for labels, boxes, and shippers. Besides the labels, a package will require the creation of specifications for each component, both printed and non-printed, that goes into the creation of that package. Packages require Dielines and technical drawings, Labels require Manuscripts, artworks require print proofs, etc.
Also, components in a pharma package can be shared across products. E.g. Inserts and Medication guides are usually a common component across multiple pack sizes of the same product. So, if this common insert changes for regulatory reasons, it will affect multiple SKUs. ManageArtworks not only manages these dependencies but also can generate alerts if there is a change that affects multiple SKUs...
Here is a representation of some of the parent-child relationships that a pharma packaging has. It shows that components are affected by Artworks and Specs. Artworks are affected by Dieline and Text matter
Managing the dependencies across all these ‘parts’ is cumbersome to say the least and requires a robust system which can handle the relationships across the product hierarchy. ManageArtworks does just that. It has the ability to manage these ‘parts’ which are continuously revised and reused across various products. Management of components in such a manner is non-trivial and ManageArtworks provides this insight into how these components are connected together so that change management becomes systematic and easy to administer

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Workflows

Typical workflows implemented for a pharma company include

Regulatory submission label creation process
Commercial Artwork Approval process
Change Request process
Print Proof approval process
Obsoleting and Print destruction process
Packaging and Print Specification approval process
Label Harmonization and De-Harmonization process

Workflows implemented in ManageArtworks have automatic audit logs, task assignment, alerts and reminders, real-time status tracking and file attachments with version control

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Workflows

Typical workflows implemented for a pharma company include

Regulatory submission label creation process
Commercial Artwork Approval process
Change Request process
Print Proof approval process
Obsoleting and Print destruction process
Packaging and Print Specification approval process
Label Harmonization and De-Harmonization process

Workflows implemented in ManageArtworks have automatic audit logs, task assignment, alerts and reminders, real-time status tracking and file attachments with version control

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Artwork Status

ManageArtworks maintains many statuses throughout the lifecycle of the artworks. The artwork can be in a ‘Draft’ status initially and move to an ‘Approved’ state once the approval workflow is completed

Once the artwork is commercially released, the status goes to ‘Effective’ along with the effective date. When a change is made to the artwork, the older version is ‘Superseded’ by the current version. Artworks can also move to an ‘Obsoleted’ or ‘Retired’ status when it’s no longer required

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Stakeholders

The in-built security in the system makes sure each of these stakeholders (especially external ones) have limited access and only to the data that they are supposed to view or take action on

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Stakeholders

Being a collaboration system, ManageArtworks brings all stakeholders both internal and external to the same page. The system can be used by all internal department users like Regulatory, Packaging, QA, Marketing, R&D, Medical Affairs, Legal, etc. and by external stakeholders like print vendors, artwork studios, LLPs, 3rd party, CMO and CPO. The in-built security in the system makes sure each of these stakeholders (especially external ones) have limited access and only to the data that they are supposed to view or take action on

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Artwork Proofing

Pharma artwork proofing is an important task and having the right tools facilitates quick review, fewer iterations and avoids errors. ManageArtworks with its own set of proprietary proofing tools deeply integrated with other functionalities gives an end-to-end solution to its customers

Graphics, Text, Barcodes and Braille can all be inspected and compared across artworks. The measurement tool allows accurate measurement of lengths & areas and the annotation tools allow users to mark-up changes on the artwork. The following tools are available for Quality control...

Barcode verification and Grading – support for Pharma codes too
Braille identification – Multilingual text identification and dot distance checking
Graphic comparison tool – pixel-to-pixel comparison
Text comparison between Word and PDF files – useful for inserts and medication guides
Spell check – Multilingual and with custom medical dictionary
Print inspection – compare scanned hardcopy to digital approved version

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Integration

Pharma companies have invested significant money and time in implementing line of business applications like SAP or other ERP systems, Quality management systems, Document Management systems, Laboratory Management systems, etc.

ManageArtworks has the capability to integrate with all these systems depending on the need. Here is a quick view of typical integrations with other systems:

Change control systems initiate change request workflows in ManageArtworks system along with a change control number.
Item codes and component codes along with BOM data are obtained from ERP. The updated BOM information in ManageArtworks can also be pushed to the ERP system.
Artwork approval status information is pushed to the ERP so that vendor Purchase Orders can be released

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Integration

ManageArtworks has the capability to integrate with all these systems depending on the need. Here is a quick view of typical integrations with other systems:

Change control systems initiate change request workflows in ManageArtworks system along with a change control number.
Item codes and component codes along with BOM data are obtained from ERP. The updated BOM information in ManageArtworks can also be pushed to the ERP system.
Artwork approval status information is pushed to the ERP so that vendor Purchase Orders can be released

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21 CFR Part 11 Compliance

ManageArtworks has built-in features to help your organization enhance your Part 11 compliance:

Access Control with Password Policies
User and Role based Security Settings
Audit Trails with Timestamps
Electronic Signatures with Authentication and Logging
SSL based communication

and more…

Validation

Computer System Validation is a key cGMP requirement which checks the effectiveness and efficiency with which the system is meeting the purpose for which it was designed

We can help your company in the CSV process by sharing templates for Validation Master Plan, Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)

Validation

Computer System Validation is a key cGMP requirement which checks the effectiveness and efficiency with which the system is meeting the purpose for which it was designed

We can help your company in the CSV process by sharing templates for Validation Master Plan, Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)

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