GMP compliance in pharmaceutical packaging & labeling

A key issue for highly regulated industries like pharmaceuticals and life sciences is compliance and adherence to the guidelines and principles of current Good Manufacturing Practices (GMP).

WebCenter QuickStart for Brands is a dedicated management system for GMP labeling and packaging artwork change management. WebCenter helps companies maintain GMP in the pharma industry.

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Challenges for pharma & life sciences companies

Pharmaceutical and life sciences companies face a wide variety of challenges:

Management of ever-increasing regulatory changes
Expansion into high-growth markets
Shorter product and innovation life cycles
Management of an ever growing and changing portfolio of SKUs

At the same time they need to make sure they avoid product recalls at all times. The consequences of product recalls are dire:

Risk to patient safety
Food and Drug Administration (FDA), and other regulatory agency, compliance issues
Cost/logistics through the supply chain
Fines
Reputation damage (brand and/or company)

A lack of an established process

The number of recalls is growing. More than 50% of recalls are related to the labeling or to the packaging artwork and more than 60% of all these recalls are caused by human error.

Often times, the root cause of these errors stems from a lack of an established packaging process. In order to reduce the risk of recalls, companies are searching for fail-safe solutions, such as software that can help them adhere to GMP regulations, packaging guidelines, and handle risk management.

Tackling good manufacturing practices (GMP) in Pharma and Life Sciences. How can Esko help?

Good manufacturing practices for pharmaceuticals require that highly regulated companies use software that is validatable (often referred to as ‘GMP compliant’), specifically against regulations set out by the FDA governing electronic systems known as 21 CFR Part 11 and the European Union Commission’s Annex 11 guidelines.

15 years of expertise

As a provider of label, artwork, and packaging management software solutions to pharmaceutical and life sciences companies, Esko has the expertise in place to ensure you maintain GMP compliance.

Esko WebCenter enables GMP labeling and packaging artwork change management.

Is WebCenter QuickStart for Brands GMP compliant?

About GMP software validation & GMP labeling requirements

Any software solution provided to a company in these industries must be GMP validatable (often referred to as ‘GMP compliant’), specifically ERES (Electronic Records, Electronic Signatures) regulations, and the vendor must be able to demonstrate that the software has been developed to contain all the necessary technical controls to ensure it meets these requirements.

Regarding GMP packaging and labeling requirements, Esko WebCenter has been developed according to GAMP5 (Good Automated Manufacturing Practices) guidelines with all the necessary technical controls in place to ensure it is fully validatable.

WebCenter QuickStart for Brands meets the GMP Pharma requirements of: FDA 21 CFR Part 11, and Eudralex EU GMP Annex 11 guideliness.

This includes ERES (Electronic Records, Electronic Signatures) and full audit trail capability.

Esko WebCenter enables Pharma and Life Science companies to effectively manage their regulatory content and artwork portfolio including pre-production specifications, content, graphics, and artwork files in a GMP compliant and secure way.

WebCenter allows you to optimize and standardize processes across all stakeholders, departments and suppliers. This will allow you to maintain absolute control over all of your artwork assets and copy, bringing consistency, repeatability and reliability to your packaging workflow.

Powerful label and artwork
management software.

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GMP compliance in pharmaceutical packaging & labeling

Challenges for pharma & life sciences companies

A lack of an established process

Tackling good manufacturing practices (GMP) in Pharma and Life Sciences. How can Esko help?

15 years of expertise

Is WebCenter QuickStart for Brands GMP compliant?

About GMP software validation & GMP labeling requirements

Powerful label and artwork management software.

Request a Demo

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Powerful label and artwork
management software.