Pharmaceutical Packaging Inspection
Automated Quality Control for Error-free Pharmaceutical Packaging
Verify labels and other packaging components for complete accuracy with GlobalVision’s quality inspection platform for pharmaceutical and life science companies.
GlobalVision will help achieve:
Fewer and Faster Revisions
Faster Approvals
Faster Time-to-Market
Regulatory Compliance
Reduced Risk of Print Errors
Reduced Risk of Recalls
Pharmaceutical Packaging Inspection
Automated Quality Control for Error-free Pharmaceutical Packaging
Verify labels and other packaging components for complete accuracy with GlobalVision’s quality inspection platform for pharmaceutical and life science companies.
GlobalVision will help achieve:
Fewer and Faster Revisions Faster Approvals Faster Time-to-Market | Regulatory Compliance Reduced Risk of Print Errors Reduced Risk of Recalls |
GlobalVision will help achieve:
Fewer and Faster Revisions
Faster Approvals
Faster Time-to-Market
Regulatory Compliance
Reduced Risk of Print Errors
Reduced Risk of Recalls
Most Common Pharmaceutical Inspection Errors
- Font differences in pharmaceutical content such as bold, italic, and underline.
- Spelling errors in pharmaceutical and medical terms.
- Unintended changes in pharmaceutical content such as dosages or ingredients.
- Pharmaceutical artwork errors such as missing graphics, misregistration, broken text, color differences, and misplaced logos.
- Incorrect Braille translation of key pharmaceutical content.
- Barcode issues such as improper decodability and a failing barcode grade on pharmaceutical packaging.
- Pharmaceutical artwork errors such as missing graphics, misregistration, broken text, color differences, and misplaced logos.
- Incorrect Braille translation of key pharmaceutical content.
- Barcode issues such as improper decodability and a failing barcode grade on pharmaceutical packaging.
How Can Pharmaceutical Inspection be Automated?
Pharmaceutical Inspection Checklist
What is being checked when running a pharmaceutical inspection in GlobalVision?
Ensures that the pharmaceutical-specific content is accurate and compliant as it moves through the regulatory process by inspecting text before submitting the final PDF.
Inspect artwork and graphics to make sure no unintended changes are created during the design process.
Verify inserts and labels while performing a check against different languages (GlobalVision can inspect up to 30 foreign languages).
Inspect tables containing pharmaceutical information.
Inspect key medical and pharmaceutical terms to ensure no spelling mistakes were made.
Compare the printer’s proof to the original PDF in Incoming Quality Assurance before going to print.
Ensures that the pharmaceutical-specific content is accurate and compliant as it moves through the regulatory process by inspecting text before submitting the final PDF.
Inspect artwork and graphics to make sure no unintended changes are created during the design process.
Verify inserts and labels while performing a check against different languages (GlobalVision can inspect up to 30 foreign languages).
Inspect tables containing pharmaceutical information.
Inspect key medical and pharmaceutical terms to ensure no spelling mistakes were made.
Compare the printer’s proof to the original PDF in Incoming Quality Assurance before going to print.
How GlobalVision Helps Companies Achieve and Maintain FDA Label Compliance
Automate proofreading during the content creation stage and ensure only intended changes are made prior to regulatory submissions.
Ensure content has no deviations from the approved SPL in either XML or PDF format.
Stay compliant with FDA labeling requirements by automating checks throughout the artwork revision stages.
Ensure that measurements of graphical components are compliant with FDA labeling requirements.
Check that font sizes of critical text are compliant with FDA labeling requirements.
Scan barcodes to confirm whether they are ISO compliant.
With GlobalVision You Can Check FDA Labeling Requirements for:
DEVICES
PRODUCTS
PRODUCTS
GlobalVision’s Automated Proofreading Products Integrate Directly With Your AMS or DAM Platform for a More Streamlined Regulatory Submission Process
To Learn More About FDA Labeling Compliance and Requirements, Head Over to Our Blog:
Ensure Your Labels Meet all FDA Drug Labeling Requirements with Automated Quality Control
Overcome Your Content Challenges in Cosmetic Labeling to Meet FDA Requirements
FAQs
Having a platform such as an AMS (Artwork Management System) or DAM (Data Asset Management System) is a great way to keep file revisions and proofs organized throughout the product development process. This is also a space where colleagues can collaborate on edits and approvals in an organized fashion. To further streamline a crucial part of the quality control ecosystem, proofreading, regulatory teams often implement automated proofreading software to easily detect errors in text, graphics, and even barcodes. Automated proofreading will also ensure that files are maintaining compliance with FDA regulations, and other regulations where your products are being sold.
To ensure that your vendor’s proof meets FDA labeling requirements and is free of any errors, you can compare it against your final approved version using an automated print inspection system. This technology will ensure that all text, graphics, barcodes, colors, and even measurements, are compliant with FDA label requirements by comparing it against your final approved version within seconds. If your print vendor is sending you digital proofs, you can use an automated proofreading software to run the inspection digitally. This type of technology works for labels, cartons, inserts, and other types of packaging components.
The alternative to automated proofreading and automated quality control are to inspect files and labels manually, which can lead to human error. Text, graphics, or barcode errors can lead to FDA sanctions, or sanctions from other regulatory bodies. Other potential repercussions include recalls, misprints, customer complaints, and lawsuits, all of which can cause financial strain to a company, depending on the severity of the error as well as at which point in the process it was caught. Automated proofreading and quality control solutions are an affordable way to prevent errors from getting by and compromising quality.
GlobalVision’s Blog, on demand webinars, as well as guides & whitepapers contain loads of great information pertaining to regulatory compliance, addressing pharmaceutical, CPG, as well as print & packaging industries. You can also join professional associations such as the RAPS (Regulatory Affairs Professionals Society) and the IOPP (Institute of Packaging Professionals) to connect with peers in this space. You can also study SPLs (Structured Product Labeling Resources) for more in depth information directly on the FDA’s website.
Protect work from critical errors with fast and accurate pharmaceutical quality inspections
- Reduce the risk of recalls caused by pharmaceutical packaging errors.
- Compare approved pharmaceutical packaging to supplier proofs to detect any deviations that may have occurred during production.
- Reduce the risk of recalls caused by pharmaceutical packaging errors.
- Compare approved pharmaceutical packaging to supplier proofs to detect any deviations that may have occurred during production.
- Ensure pharmaceutical packaging compliance in all markets where products are sold.
- Manage pharmaceutical regulatory and localization requirements by easily proofreading foreign languages.
Get pharmaceutical products to market faster by reducing delays caused by manual proofreading
- Cut pharmaceutical packaging proofreading time in half by implementing digital inspections throughout the entire workflow.
- Manage revision cycles by running complete pharmaceutical inspections at every touchpoint.
- Accelerate pharmaceutical approvals by keeping track of version changes between departments.
- Generate complete pharmaceutical inspection reports to easily communicate changes between departments, supplies and agencies.
Automated Quality Control for Every Stage of the Pharmaceutical Workflow
Run seamless inspections across your entire organization with GlobalVision’s inspection tools built for all departments.
Regulatory
Affairs
Localization
Graphics
Packaging
Quality
Assurance
Printing
Regulatory Affairs, Scientific Affairs, and R&D in Pharmaceutical
Add a GlobalVision Scanner System for Print Inspection
Keep files compliant with FDA guidelines as they move through regulatory departments.
Stop errors from being created as pharmaceutical content is transcribed from reference materials.
Automatically inspect text-heavy documents with character-to-character precision.
Ensure that the correct FDA information is formatted and applied to pharmaceutical labels and packaging.
Manage Localization by ensuring that content is accurate for use in foreign markets.
Get products to market faster by eliminating long delays caused by manual quality control.
Automatically compare text and spelling in over 30 languages.
Check final regulatory documents against approved content to make sure they’re consistent before moving to graphics.
Graphics, Artwork, and Marketing and Design in Pharma Packaging
Meet the standards of your pharmaceutical and life science clients by catching critical errors on pharmaceutical and medical content.
Meet FDA, CGMP, European Commission, and other Regulatory Bodies?
Improve your full edit with GlobalVision’s spelling verification module that includes a medical and customizable dictionary.
Verify that the internally improved version matches printed or live samples.
Packaging, Labeling and Product Development in Pharma Packaging
Compare prepress files to customer-approved PDFs before going to production. Maintain the integrity of your content by ensuring that no errors have been introduced during the file conversion process.
Compare print-ready step-and-repeat files to the approved artwork file.
Run side-by-side inspections to detect any deviations between files.
Prevent files from becoming distorted as they’re converted from artwork files to printing plates.
Easily navigate through layers and separations of your files to detect all differences.
Generate comprehensive inspection reports to review and navigate through all found differences.
Incoming Quality Assurance and Quality Assurance in Pharma Packaging and Production
Ensure that pharmaceutical packaging gets to market error free by implementing GlobalVision’s quality control platform which enables offline inspections by scanning physical samples and comparing them back to the original artwork file that was submitted to the supplier.
Digitally inspection production samples to catch all differences in text, graphics, barcode, spelling and color.
Prevent raw material loss, complaints, and recalls by making sure each printed packaging component hasn’t deviated from the approved artwork.
Protect end-users final printed packaging with pharmaceutical packaging that’s 100% accurate.
Print Pharma Packaging Materials
Eliminate project delays caused by manual proofreading inefficiencies.
Speed up time-to-market by helping your team keep track of version changes while ensuring that the right content was printed onto pharmaceutical packaging components.
Keep track of changing product lines by easily managing multiple production samples from various print suppliers.
Electronically sign-off on printed pharmaceutical packaging materials to accelerate approvals.
Save and share detailed inspection reports that facilitate communication between departments and suppliers.
Quality Inspections for the entire Pharmaceutical Workflow
Inspect Various Pharmaceutical Packaging Components:
Compliance and Data Integrity
Meet compliance and data integrity requirements with inspection technology developed for the pharmaceutical industry.
ISO is implemented and maintained at all levels of the company to ensure that:
- Noncomforties are rapidly detected and controlled
- Designed and integrated products conform to specified requirements
- Corrective and preventive measures are taken to avoid the recurrence of non-conformities
> 21 CFR Part 11 Compliant:
All Technical Controls for 21 CFR Part 11 Compliance are built into GlobalVision’s products.
- Audit trail
- Electronic signatures
- Login management
- User access controls
- Admin controls
> Annex 11 Compliant:
Required for use in the EU, GlobalVision has all Technical Controls for Annex 11 compliance built into our products.
Current Good Manufacturing Practices ensure that products are consistently designed, produced, and controlled according to quality standards. GlobalVision is strongly committed to following these standards and practices to ensure that our systems are built for use in regulated industries.
> GAMP 5 (Good Automated Manufacturing Process) Compliant:
GlobalVision is compliant with GAMP 5 guidelines by building systems that meet regulatory requirements and are fit for use in the pharmaceutical industry.
> Audit Trail Mode:
The audit trail is a complete record of all activities performed within the software which can be filtered by event type, user, and time period – allowing for full visibility and traceability of software usage.
FAQs
Automated quality control like GlobalVision helps pharmaceutical companies prevent recalls by instantly catching label and packaging errors before they hit the shelves. GlobalVision helps ensure pharmaceutical packaging compliance by easily proofreading labels and packaging components.
Learn more about how automation technology helps pharmaceutical companies prevent packaging errors.
GlobalVision’s inspection modules for pharmaceutical companies include:
Text Inspection for pharmaceutical companies
Graphics Inspection for pharmaceutical companies
Print Inspection for pharmaceutical companies
Color Inspection for pharmaceutical companies
Barcode Inspection for pharmaceutical companies
Braille Inspection for pharmaceutical companies
Automated packaging inspection replaced manual proofreading to ensure the accuracy of labels and packaging. With automated packaging inspections, pharmaceutical companies can run digital quality inspections that get their products to market faster without compromising quality
GlobalVision’s inspection tools digitally compare two files to identify any differences between the two. With GlobalVision, you can verify digital and printed content against approved files for 100% accuracy.
Suggested Readings
Suggested Readings
GUIDE
5 Common Packaging Mistakes in Pharma
Discovering an error in the middle of printing or even getting a worrisome call from distributors as a product hits shelves are unfortunately a part of business. Oversights happen, and many don’t realize simple safeguards exist to catch mistakes before they become costly. In this whitepaper, we’ll discuss the most common errors in print packaging, why they occur, and how to prevent them.