Data Security

Everything you need to know about GxP Certification

Written by: Anne Gotay 5 min read

Safety is the most critical concern in the Pharmaceutical industry today. Guaranteeing that patients get effective and beneficial drugs requires an oversight process for the development of medicines. Oversight must extend from inception through production and apply rigorous standards. Rather than simple checkboxes, researchers and manufacturers need a holistic quality-first approach to development.

GxP is one way that organizations demonstrate they adhere to high standards for the production and development of medications, vaccines, and medical devices. Certification validates they have achieved these exacting standards. This article will explore what GxP is and why it is vital that pharmaceutical companies achieve GxP certification.

 

What is GxP?

GxP is a collection of organizational processes involving data collection, handling, and tracking throughout the organization. This set of standards was established by the United States Food and Drug Administration (US FDA). It shows that a business complies with specific and secure manufacturing and storage processes and procedures. GxP is not limited to the US alone. It’s included in publications by the European Medicines Agency (EMA), the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), and the International Organization for Standardization (ISO).

GxP is a more generic term for several domains across the lifecycle of development. The ‘x’ is short for the sub-field that it represents.

  • GCP – Good Clinical Practice
  • GdocP – Good Documentation Practices
  • GDP – Good Distribution Practice
  • GLP – Good Laboratory Practice
  • GMP – Good Manufacturing Practice
  • GRP – Good Review practice
  • GSP – Good Storage Practice

To meet GxP, an organization needs to comply with each of the areas that make up GxP. These procedures span across drug manufacturing, clinical trials, and laboratory trials. These processes and procedures center on the pillars of accountability, integrity, and traceability.

 

Accountability

Accountability involves understanding who was involved in developing a product and how they contributed. It requires in-depth record-keeping of who made contributions, in what areas, and when. This information allows organizations to look back and ask questions to those involved in research and development.

This is especially important when a drug causes unexpected adverse events. An investigation is needed to identify issues with the development process. Finding a person to blame is not the point of these investigations. Instead, they determine where mistakes might have occurred then develop steps to guarantee these do not happen again.

 

Integrity

Data integrity covers the reliability and quality of the data created and stored. To deliver that, pharma companies need to protect their data from any accidental or intentional changes. These changes need to be tracked and attributed to the change source for auditing and validation. When data is modified, duplicated, deleted, or falsified, the ability to deliver a safe and quality product is damaged.

 

Traceability

Traceability is the ability to track a drug or medical device’s entire development history. This is also important for performing failure investigations when a drug or device fails to perform as expected. This is vital for locating process or procedural failures that had nothing to do with the individuals performing them. Instead, they may be related to design failures or incomplete documentation for processes. Much like with accountability, this information should be used to help improve organizational quality.

 

Why Does GxP Matter?

Meeting formal GxP certification is not a requirement to develop and manufacture drugs and medical devices. However, researchers and manufacturers are still required to follow Current Good Manufacturing Practice (CGMP) requirements. These requirements are similar to GxP, and attaining GxP means that your organization already meets or exceeds CGMP.

GxP shows consistency in practices that are also auditable. GxP requires highly detailed and specific documentation, and it is an effective record of every development and production lifecycle step. When it comes to patients, GxP is also important for instilling trust. GxP compliance assures patients that every step in producing their medical drugs and devices is done safely. It shows that the research going into the development was done ethically and humanely, adhering to the highest standards of accuracy.

 

How to Attain GxP?

Attaining GxP is not an easy process for an organization to take on its own. Developing a new treatment in a complex pharmaceutical organization involves numerous individuals and interconnected devices. Tracking how data is produced and properly attributing it in real-time is a daunting task.

To attain the consistency and tracking of data requires a solution that helps automate this undertaking. The automation of data gathering guarantees that information logging is never skipped because someone is too busy.

Attaining GxP also requires having a solution that can guarantee authorized users only alter that data. This requires controls to limit access to the data and prevent it from being modified when in use and in transit. Any alterations to the data that are not authorized can have significant consequences.

 

Trusting Experience

The Sotero Data Security Platform is validated to support regulated computerized systems and environments. Sotero has experience in helping pharmaceutical organizations achieve outstanding outcomes. Sotero works directly with IT and data teams to deploy, test, and validate Sotero’s revolutionary data security platform. Clients have seen results in a matter of weeks. Not only did they meet data security and privacy requirements, but they realized faster drug development timelines. Schedule a demo to learn how Sotero can help your organization secure its data while optimizing for innovation.

Tags:

data protection,

data regulations,

data security

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