GxP Compliance: Guide To Create A Safe, Effective And Usable Plan

GxP Consultants


In the rapidly evolving landscape of industries such as pharmaceuticals, biotechnology, and healthcare, adherence to Good Practice (GxP) standards is not just a regulatory requirement; it’s a cornerstone for ensuring product quality, patient safety, and operational excellence. As organizations continue to innovate and expand their capabilities, understanding and implementing GxP compliance becomes paramount.

What Is GXP Compliance?

To answer this question, one first needs to know what GxP is. The “G” stands for “Good,” and the “P” stands for “Practices.” The “x,” just as in mathematics, is a variable—it can stand for many things. Like mathematics, the trick is to “solve for x.” That’s where Compliance Team’s GxP consultants can help.

How To Solve For “X” In GxP

We explore the dynamic challenges within the GxP (Good Practice) framework, offering practical solutions for organizations aiming to address the variable factors—represented by ‘X’—that influence compliance in industries such as pharmaceuticals, biotechnology, and healthcare. This article guides readers through strategies to identify and effectively manage the unknowns, uncertainties, and evolving requirements inherent in maintaining GxP compliance, ensuring a robust and adaptable approach for success.

Here are few possible solutions for x:

  • GMP: Good Manufacturing Practices—Depending on the product manufactured, the regulation for GMP will differ.
  • 21 CFR 210/211 (GMPs for Finished Pharmaceuticals)
  • 21 CFR 110 (GMPs for Human Foods)
  • 21 CFR 111 (GMPs for Dietary Supplements)
  • GLP: Good Laboratory Practices—These are the best practices for laboratory testing, in 21 CFR 58.
  • GCP: Good Clinical Practices—The standards for ensuring safe clinical trials that yield unbiased, truthful information. Numerous standards apply here, including 21 CFR parts 50, 58, 312, 320, 511, and 812.
  • GDP: This is not Gross Domestic Product, but can mean two things:
  • Good Documentation Practices—Requirements for ensuring that documentation meet the ALCOA principle: Documentation is Attributable, Legible, Contemporaneous, Original, and Accurate. 21 CFR Part 11, Annex 11 (Europe) and the GDP Guidance.
  • Good Distribution Practices—Standards for ensuring that products are stored, shipped, and identified during transit so they safeguarded from adulteration. The standards  for distribution include VAWD, & DSCSA for drugs, and the UDI Final Rule for medical devices.

That’s where GxP Compliance Consultants can help your team make sure they are on top of the latest regulations and requirements.

How To Implement GxP Regulations

The regulations cannot be implemented at face value, in fact they are worded vaguely to allow flex as the state-of-the-art in the subject area evolves. For example, 211.58 states, “Any building used in the manufacture, processing, packing or holding of a drug product shall be maintained in a good state of repair.”

A layperson may not know how to implement this rule into a meaningful standard, because what constitutes a good state of repair? A consultant can assist the company with how to convert this vague statement into tangible requirements.

In fact, GxPs are often referred to as cGxP. The little “c” in front stands for “current.” That little “c” is a reminder that the GxPs change over time, as the state-of-the-art for a particular technology evolves.

For example, laboratory instruments are now built with controlled logins, unique to individual equipment users. In the past, instruments may have been built to enable a single “departmental” login, or no logins at all. The Current GLP expects a unique login and password for each authorized user.

GxP Compliance Is Essential For Businesses

Compliance Team will provide a subject-matter expert who can relate to your business challenges and help you achieve your GxP compliance goals. The expert we assign will understand the subject area and identify the GxP standards suit the situation.

Then, our experts can perform a gap assessment to find the highest-impact areas for focus, based on gap size and its relative importance. Compliance Team GxP Compliance Consultants will then customize a plan to  help your team meet their GxP goals and requirement.