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GMP compliance in pharmaceutical packaging & labeling

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

Esko Platform For Brands is a dedicated management system for GMP labeling and packaging artwork change management. Esko Platform For Brands helps companies in the highly regulated industries control and maintain their GMP compliance with ease.

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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 & 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
  • FDA (and other regulatory agency) compliance issues
  • Cost/logistics through the supply chain
  • Fines
  • Reputation damage (brand and/or company)
Challenges for pharma companies

GMP compliance

A lack of an established process

The number of recalls is growing. Over 50% of those are related to the labelling or to the packaging artwork. Over 60% of all recalls is caused by human error.

A lack of an established process within the business is often cited as a source of errors. No wonder then, that these companies are looking for fail-safe solutions: software that can help them maintain GMP packaging and labelling guidelines.


Tackling good manufacturing for pharmaceuticals. 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 Commission’s Annex 11 guidelines.

As a provider of packaging and labelling management software solutions to pharmaceutical and life sciences companies for over 15 years, Esko has the expertise in place to ensure you maintain that compliance.

Esko Platform For Brands is a dedicated management system for GMP labeling and packaging artwork change management.

Benefits for life sciences and pharma companies

Is Esko Platform For Brands GMP compliant?

About GMP labeling and packaging 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.

Specifically in terms of GMP packaging and labeling requirements, Esko Platform For Brands 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.

Esko Platform For Brands meets the requirements of:

  • FDA 21 CFR Part 11 guidelines
  • Eudralex EU GMP Annex 11 guidelines

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

GMP software validation of Esko Platform For Brands is a given and GMP verification is not an issue. This provides you with peace of mind that the Platform will perform according to your requirements and will significantly reduce your own levels of resource and effort involved in validation and verification.

Esko Platform For Brands allows you to optimize and standardize processes across all stakeholders, departments and businesses. This will allow you to maintain absolute control over all of your assets and copy, bringing consistency, repeatability and reliability to the workflow.

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