Overview

In the world of pharma packaging and labeling, efficiency, consistency, and speed to market are critical priorities. Yet, given the highly volatile nature of the packaging market, pharma companies face several challenges in getting their designs right the first time. Frequent regulatory changes, the emergence of new packaging trends, and a highly complex supply chain make proofreading pharma packaging artwork an uphill battle. 

Understanding the Complexity of Pharma LabelProofing ‍

Pharma companies face several obstacles in streamlining submission and commercial artwork workflows and ensuring seamless coordination and efficiency throughout the entire artwork lifecycle. Let’s look at the top challenges that impact pharma artwork management: 

• Frequent labeling changes: Pharma products are subject to several drug safety-related labeling changes. Companies must stay ahead of the latest requirements, update safety information in labeling, and get necessary pre-market approval. They also need to submit artwork to regulatory bodies before launch while ensuring every change suggested by the regulatory body is approved within the stipulated time to avoid penalty. Without the right proofing systems or processes in place, checking and verifying if changes adhere to necessary labeling requirements is difficult.  

• Presence of multiple stakeholders: The packaging supply chain comprises various stakeholders, from designers to QA, marketing, legal, finance, regulatory, and more, each with a unique set of roles and responsibilities. With so many people involved, designing, developing, testing, validating, and proofreading different packaging components according to required specifications and requirements is tough. It demands regular communication and seamless project management between all parties and a common centralized platform where all packaging artwork can be stored, verified, and checked for accuracy and compliance.

• Numerous regulations: Pharma packaging is driven by compliance. Any drug, whether in the market or in the launch process, goes through numerous changes driven by regulatory needs. Adapting to frequent changes arising from regulatory updates and constantly proofreading them to ensure accuracy and compliance is a Herculean task. In the absence of the right proofing software in place, pharma companies often face several hurdles in ensuring regulatory submissions, approving artwork, and catering to varied print & packaging specifications.

• Various packaging formats: In the pharmaceutical industry, various packaging formats add an extra layer of complexity to the proofreading process. From cartons to foils, vials, sachets, ampoules, leaflets, etc., proofing and submitting correct artwork for different formats and strengths and addressing changes in a matter of a few hours is crucial to accelerate time-to-market Complex supply chain: Getting the packaging right the first time is never easy for pharma companies. Despite drugs being ready, companies are unable to bring them to the market because of the complexity of the supply chain. With 70-80% of drugs being generic, ensuring the right fonts, colors, design, image placement etc. for each drug is crucial to increase sales and drive revenue.

The Benefits of a Packaging Artwork Solution ‍

Given the criticality of getting pharma packaging right, companies must consider investing in a modern packaging artwork solution. The right solution acts as a centralized hub for managing all aspects of the artwork, from initial design and regulatory approvals to commercial deployment and eventual obsolescence. This accelerates time-to-market, ensures compliance with regulatory standards, reduces errors, and enhances collaboration across teams. Here’s how a modern packaging artwork solution helps overcome proofreading challenges: 

• Seamless artwork lifecycle management: A packaging artwork solution paves the way for seamless artwork lifecycle management. Offering a single, centralized platform, it allows all internal department users like regulatory, packaging, QA, marketing, R&D, medical affairs, legal, etc., and external stakeholders like print vendors, artwork studios, LLPs, 3^rd party, CMOs, and CPOs to design, review, approve, and manage pharma artwork quickly and seamlessly. ‍

• Robust change management: A packaging artwork solution standardizes typical workflows across regulatory submissions, artwork approval, and print and packaging specs. Integrating seamlessly with regulatory and quality management systems, the solution automatically routes changes to respective departments for artwork design, proofing, and approval. This allows companies to adapt easily to frequent label changes and regulatory updates, accelerating time to market and ensuring compliance with regulatory standards. 

• Automated audit logs: Modern artwork management solutions offer automated audit logs that make it easy for pharma companies to track and manage artwork copies. These logs give stakeholders much-needed visibility and insight into who has made the latest artwork change, why, and how. The solution allows users to monitor progress and update artwork status accordingly by assigning various statuses to the artwork throughout its lifecycle. 

• AI proofing across artworks: Regardless of the type of artwork format, pharma packaging artwork solutions enable AI artwork proofing for graphics, text, barcodes, and Braille. Pharma companies can inspect and compare text, design, and compliance across artworks and networks. They can also ensure accurate measurement of lengths and areas and leverage annotation tools to markup changes on the artwork. 

• Access control: Modern pharma packaging artwork systems also take security very seriously, offering robust access control measures. With built-in features that help enhance your Part 11 compliance, these systems encourage strong password policies, strict user and role-based security settings, audit trails with timestamps, electronic signatures with authentication and logging, and SSL-based communication. 

• Digital asset management: Since pharma packaging artwork solutions centralize all assets in one place, they allow stakeholders to work and collaborate on the most recent versions of artwork files. Advanced digital asset management allows companies to easily handle various file formats using this solution, including PDF, image, document, audio, and video formats. They can also manage a diverse range of files connected to artwork, such as product briefs, specification documents, font files, source files, images, pack shots, promotional videos, and more – and use the solution as a central hub for all their digital asset requirements.

The FDA requires pharmaceutical packaging labels to display specific data, including how to use the medication and exact dosages, usage warnings, and a complete list of ingredients. Any error, misprint, or design inconsistency can lead to high penalties, causing companies to witness a dip in revenue and customer satisfaction. 

If you want to get your pharma packaging right the first time and simplify the proofreading process, you must adopt a robust packaging artwork solution. The right solution can help you stay ahead of the latest trends and ensure compliance with regulatory changes.