How is your company managing risks related to packaging artwork development? 

Let’s start with a case study. A mid-sized pharmaceutical company, engaged in packaging artwork management and artwork studio services, did not deploy artwork proofreading system at the artwork studio level, though it had an electronic proofreading system in review and approval stage for the Regulatory Affairs (RA) team. Due to this structure, the approval process to finalize an artwork was long and tedious.  Any error introduced by the artwork studio was picked at the review and approval stage, further adding time to the artwork approval process and increasing the number of versions.  

The solution: Deploying Quality Control Analysts during the proofreading

As part of the artwork management services and process improvement initiatives, a detailed study was done on the process. To improve timelines and people competencies, electronic artwork proofreading systems were deployed at the artwork studio, along with recruitment of Quality Control Analysts (QCA). Every artwork created inside the artwork studio was proofread by the QC team with the help of the electronic tool and any error was quickly addressed by the artwork operators before it reached the RA team for review and approval. This additional process step helped in improving quality and reduced timelines to market. In the process, auditing requirements were also kept in the purview. Version control was taken care of with each loop from QC person to artwork operator.  

Role of Quality Control Analysts

Quality Control Analysts are also known as artwork proofreaders in some pharmaceutical and life sciences companies. They play a pivotal role in ensuring that packaging artworks are created as per the labeling documents available and approved as per related health authority requirements. Not only text, they make sure all the technical components such as dimensions, barcodes, braille, and colors are perfect in terms of artworks and printing.

There are several off the shelf tools/artwork inspection tools available in the market for the purpose of electronic proofreading of packaging artworks. Some of these include: Global Vision, TVT by Schlafender Hase, Informa IT, and EyeC Inspection.

Wipro’s approach to proofreading and quality control

Integrated with a 360-degree perspective on artwork lifecycle management, right from core labeling text to packaging artwork design to printed packaging material, Wipro offers its clients an effective proofreading/QC system that checks for quality defects across the pipeline.    

The proofreading/QC checks within the artwork quality management include:

• Pixel-to-pixel check
• Text check/comparison
• Barcode check
• Braille check
• Color check

Wipro’s proofreading/QC approaches:

• 4-Eye approach: This is an approach where two people approve a particular process flow, with one reviewing the work and another approving it.
• Region-specific regulatory experts: Artwork are created for various regions around the world. We have regulatory experts working for specific regions and ensuring error free artwork.
• Right-First-Time approach: This entails the collection of data related to artwork change from stakeholders, artwork operator practices and sharing the deficiencies with the team and ensuring best practices are shared and ensuring process improvement takes place.

Once the artwork operator completes the creation of the artwork, the next process step is to do proofreading/QC of artwork created. This should be end-to-end proofreading of packaging artwork and labeling documents with the help of industry standard electronic proofreading tools for technical and text checks which may involve manual proofreading in some cases for elaborate quality check of artwork created. Activities that are required to be performed at proofreading stage may include:

• Comparing artwork document with the available source document
• Product name check along with active ingredient or generic name
• Strength/dosage/units with the quantity of the pack
• Company name (MAH) should be reflecting properly
• Making sure annotations marked by stakeholders are carried out
• Checking of font type, font sizes applied on the artwork and making sure size is as per HA requirement
• Component number placement and availability on the artwork
• Technical checks
• Dieline checks such as dimensions, barcode and braille information and placement
• Orientation of artwork
• Barcode and pharmacode checks, pagination, disclaimers, TEP areas, overprinting areas, text area, text free zones, varnish, eye marks, roll direction, etc.
• Trim and bleed values check
• Crop marks and registration marks check
• Check on live text and hidden text
• Checking of text placement and alignment along with symbols and special characters used

Other activities include:

• Checking of file naming convention as per the company (IP) requirement.
• Checking the completeness of Artwork Information Panel (AIP) with accurate information.
• Filling and filing of checklist for audit purposes.

Quality assurance with artwork management is critical and its proper usage in each workflow step is vital for the success of the process. Not only does it save cost but also improves the process and functioning of the related supply chain. This allows faster production and time to market.