Pharmaceutical packaging transforms formulation into a marketable product. However, it needs to adhere to strict packaging regulations. Even a minute error in the packaging might lead to product recall and health authority warnings. About 30%-40% of product recalls are due to packaging and labelling errors.
Freyr estimates that pharmaceutical packaging may cost up to 70% of the drug’s cost. To prevent incurring losses due to incorrect labelling, validation of packaging artwork is a mandate. This makes the artwork approval process in pharma intense and involves various departments like product, packaging, marketing, legal, and finance.
Unfortunately, artwork management in pharmaceutical also becomes cumbersome because of the changing market and regulatory requirements.
This article covers techniques to maximize productivity and minimize the drug’s time-to-market in the ever-changing pharma market dynamics. But before, let’s have a look at typical hurdles in pharmaceutical artwork management.
Obstacles in Pharmaceutical Artwork Management
Usually, pharmaceutical manufacturers export products globally. Each country has its packaging specifications. For the export-products, it is difficult to manage artwork manually for region-specific requirements. Following are pharmaceutical industry challenges for managing packaging artwork.
1. Challenge – Collaboration
Collaboration between different teams involved in pharmaceutical packaging is crucial. However, manual processes restrain the ease of working together. Pharmaceutical artwork approval becomes tedious because of the following reasons.
Traditional Communication Channels
Companies use emails, phone calls, and messenger chats for communications. Teams generally end up losing important information because of multiple communication channels.
Consider a scenario when the legal department conveys a sudden change in regulation to the design team on phone. Design team updates the change, but there’s no official record for this communication. It may lead to a hit or miss situation during packaging review.
Changing Regulatory Environment and Regional Specifications
The pharmaceutical packaging should adhere to the regulatory compliance and current Good Manufacturing Practice (cGMP) guidelines. However, some of these guidelines might change to accommodate local safety measures.
The pharmaceutical supply chain operates globally. Therefore, companies accord with a wide range of regional regulations. The legal department needs to stay updated with the current regulation and immediately convey any changes to collaborators.
Matching Labels with Company Core Data Sheet (CCDS)
A company’s Core Data Sheet is an internal company document that represents its safety profile of any drug. Company’s manager for regulatory affairs updates CCDS periodically. The new packaging label needs to comply with the latest CCDS before launch.
2. Challenge – Validation
Incorrect information on the pharmaceutical packaging leads to warning from health authorities and hefty fines. Also, certain drugs require information in regional script and braille. Manual packaging artwork approval is prone to translations and braille script validation errors.
For instance, the US FDA (Food and Drug Administration) issued 217 drug recall notices in 2018. Out of these more than 12% were due to mislabeling incorrect information on packaging.
3. Resource Challenges
Pharmaceutical labelling requires dealing with sophisticated data like chemical composition, CCDS, and compliances. Often these data are stored in different file formats and multiple locations. Deriving relevant information from non-user-friendly file formats is tedious and cross-checking package label is error-prone.
Maximizing Productivity in Pharmaceutical Artwork Management
To address these challenges, pharmaceutical companies should maintain complete control on packaging artwork process flow. It includes managing resources, communication, and collaboration efficiently.
A practical approach to eliminate proofing errors and maximize productivity is using artwork management software such as Artwork Flow. Following are the benefits it incorporates.
1. Online Proofreading
A minor spelling mistake can cause serious legal implications on the pharmaceutical packaging label. But, the hassle to proofread pharma packaging content is enormous. The traditional way requires downloading files, marking corrections, sharing with the design team to update. And this follows a loop pattern if all the corrections aren’t identified at a time.
Instead, artwork management in pharmaceutical can be simplified with a software which allows proofreading the artwork online. Proofreading tools can root out human-errors to a great extent. A tool like online spell-checker is also helpful for proofreading industry-specific content. It highlights all the wrong spellings in the packaging artwork and suggests corrections.
2. Version Control
While working in a collaborative environment, it is essential to ensure that everybody is looking at the right version at any point in time. Since pharmaceutical artwork approval involves handling several data sets, managing documents in a uniform file-format are essential.
Also, it requires multiple revisions, therefore, it’s of great help to keep track of versions according to the feedback from authorities.
3. Cloud-Based Library
A cloud asset library is a repository of all reusable brand assets like logo, labelling and packaging templates and more. It ensures that resources are available to the stakeholders throughout the packaging development and product release.
4. Multi-lingual Support
Some advanced artwork management packages allow in-built content translation with a high degree of accuracy.
5. Global Online Approval
Pharmaceutical packaging needs validation from regional managers to ensure it complies with the local regulations. Approval from authorities irrespective of location is possible on SaaS platforms such as Artwork Flow.
Artwork management in pharmaceutical industry encompasses project management, label regulatory control, watching market trends, and resource management. Therefore with an efficient artwork management software, pharma manufacturers can streamline their packaging processes to keep pace with the changing market dynamics.0