MEDdesign

Compliance Is Compulsory, and Product Labeling Is No Exception

By Beth Peckover
January 4, 2021


• Categories: 03-Manufacturing Execution, 04-Product Design & Development, 05-Quality/Regulatory, MEDdesign

Enforced by regulators such as the FDA in the United States, HS-SC in Canada, TGA in Australia and EMA in Europe, the validation of computerized systems is non-negotiable. Being able to prove adherence to appropriate processes and practices which underpin a risk-based, quality driven approach to validation is a pre-requisite for operating in highly regulated markets, including both pharmaceutical and medical device manufacturing.

Manufacturers working in highly regulated industries must, as part of GxP regulations, adhere to good manufacturing practices (GMP) defined as “a system of processes, procedures, and documentation that helps to ensure that products are consistently produced and controlled according to quality standards.” It is important to particularly focus on GAMP 5 guidance for GxP computerized system compliance and validation, as this is the standard to which industry regulators work.

Out with the Old, in with the New

For products such as pharmaceuticals and medical devices, computerized systems for enterprise labeling play a central role in providing high quality and accuracy to the branding of products. Meeting regulations means applying best standard operating procedures (SOPs) and quality management systems to the design, development and delivery of labeling software.

Despite pharmaceutical and medical device labeling being a prime target for modernization, many manufacturers continue to use outdated product labeling systems because of their unwillingness to bear the burden of validation during new system implementation. Validation of new computerized systems is an involved task, usually taking months to complete and entailing operational, performance and infrastructure qualification of regulated systems used in the manufacturing of pharmaceuticals and medical devices.

Recalling Products Is a Costly Business

FDA drug recall data shows between 2017 and 2019, 14.9% of recalls were attributed to labeling issues. Statistics have recently highlighted 9% of medical devices recalled globally were due to labeling errors, a figure which equates to over one million items.

The FDA explains quality assurance (QA) programs used by medical device manufacturers must include elements that pertain to labeling to meet the GMP requirements of the Quality System regulation. For consumers and company reputation, a recall caused by failing to meet regulatory standards could result in serious damage – from the closure of businesses to risking patient safety due to incorrect labeling.

Deploying a Bespoke System Is No Easy Task

The validation of new computerized systems is an involved task and many pharmaceutical or medical device manufacturers can find themselves between a rock and a hard place when assessing labeling system options. While an organization might have a validated legacy labeling system which requires an update, this alternative is developing a new system which itself would require complete validation.

In-house system development puts the validation burden directly onto the pharmaceutical or medical device manufacturer. If manufacturers cannot isolate the driving factors behind a computerized system’s selection or development, or how to test and satisfy them, then manufacturers will struggle to establish whether a system is fit for purpose or not.

Without a proper definition as to why a system is put into place, inconsistencies, incomplete computerized systems and feature creep gaps can all be present during system deployment. With a lack of adequately documented requirements and testing processes, businesses will find it impossible to claim to have compliant systems in place.

Achieving Continuous Compliance = Large Costs and Complications

It is more likely manufacturers will invest more time and effort in the validation process of their own bespoke on-premises application as they hold ultimate responsibility for performing qualifications after each release.

Rule assessment is a constant process. Requirements have to be continuously kept up to date throughout the lifecycle of the software system. To ensure compliance with regulation, manufacturers must establish both a lean governance structure and standard operating procedures to interpret all regulations and requirements on an organizational level, responding and acting where needed.

Validation? Just Pass Go!

Third-party, pre-validated solutions offer an alternative that reduces the compliance burden of operating a best-practice, modern labeling system. Such solutions should build and demonstrate GxP compliant processes across creation, review, print and publication of product and package labeling. The software should also align to 21CFR Part 11 regulations and GAMP 5 quality guidelines.

Considering this, three crucial areas exist that businesses must focus on when setting criteria for a validated enterprise labeling system.

First – Look to the Cloud for Validation

Rather than develop an in-house custom solution, another option is for businesses to leverage existing market software. Although there is an option to be installed “on-premise”, the software is typically delivered in a software as a service model (SaaS) and offers organizations benefits in the form of efficient validation, during both initial implementation and the ongoing system maintenance processes.

Using cloud-based software means the software provider assumes responsibility for IQ/OQ validation during each update, providing a validation-ready software system and minimizing a manufacturer’s own validation efforts and costs.

Next – Let Suppliers Take the Strain of Validation

Following validation-ready system delivery, the software supplier will have the capabilities and experience to assume responsibility for other elements of the validation process if requested. This can include overseeing the creation of a traceability matrix or the writing of test scripts for user acceptance testing (UAT).

Outsourcing a large portion of these activities to the supplier is a strong option, leaving the UAT execution as the only aspect to be completed by the manufacturer.

Aligning Industry Regulations Affords Compliance Collaboration and Expertise

A trusted software partner, with in-house experts in GxP and GAMP 5 who train to stay up to date with the latest guidelines and best practices, can bring industry-wide compliance knowledge and expertise to a manufacturer. This means medical device and pharmaceutical manufacturers can, despite their own unique requirements and processes, tackle common challenges and scenarios their software provider previously encountered.

This co-operation enables a partner to collaborate with the manufacturer directly, consulting on how label changes can affect compliance moving ahead and discussing the steps needed to ensure any new process adheres to best practices.

Finally – Effective Partnerships Deliver Validated Platforms Ready for the Future

The pace of technology change in combination with ever-changing manufacturing processes makes adherence to GxP and GAMP 5 regulations in the medical device and pharmaceutical industries a constant task—one that swiftly becomes unsustainable when manufacturers weigh the compliance pros and cons of deploying a bespoke, on-premises enterprise labeling system.

Working in partnership with a reliable software provider is critical for ensuring computerized systems validation and the creation of a platform compliant with any industry mandates as and when they occur. Assuming the process is followed, it will produce an end result that is collaborative, efficient and which satisfies compliance guidelines, delivers huge value and eliminates risks from manufacturing processes.