What is GxP in the life sciences industry?

    In the 1990s, the drug fen-phen soared in popularity as many people used it to help with weight loss. However, the drug began to cause heart valve issues for several women who were using it. The FDA recalled the drug and found out later that an official within the company responsible for producing fen-phen had expressed concerns about these side effects years before.

    After that, pharma companies paid out billions of dollars to those affected by fen-phen, losing not only money but also credibility in the pharmaceutical industry. Costly issues like this can be prevented by following correct procedures and regulations. When a drug or a medical device doesn’t work correctly or produces undesirable side effects, that’s often due to a failure to follow the quality procedures and processes established in a quality system.

    The FDA, along with input from the International Conference on Harmonization (ICH) and other agencies as applicable, developed GxP standards to control the quality of FDA regulated goods. The GxP standards, although mandated under CFR Title 21, allow the entities some flexibility to implement their own standard operating procedures, as long as they are following their applicable set of guidelines and regulations.

    The term GxP encompasses many areas of compliance related activities and is vital to FDA regulated companies as they plan out their internal quality management processes, with the end goal of protecting public health and protecting your company from encountering adverse events.

    FREE DOWNLOAD: Get the GxP compliance checklist 

    What is GxP?

    Just as the example above illustrates, GxP guidance was established to help prevent disasters in the life sciences industry, like the thalidomide tragedy in the late 1950s to early 1960s that caused thousands of birth defects. GxP sets the minimum requirements for quality management and gives a framework for continuous improvement, so companies can enhance their overall product quality. The GxP regulations specifically focus on the areas of data integrity, traceability, and accountability so that companies have rules in place to document their development process, document responsible parties that created the regulated product, and overall the reliability of the supporting data.

    Put simply, GxP is an abbreviation used to refer to good practices. The “G” stands for “good,” and the “P” stands for “practices.” The “X” is a variable and can stand for different parts of the drug or device production process, with the main three being GMP, GCP and GLP:

    • Good Manufacturing Practices (GMP): These practices help ensure that products are produced according to established quality standards. FDA regulations surround all aspects of manufacturing, from where raw materials are sourced to how standard operating procedures (SOP) are followed.

    • Good Clinical Practices (GCP): GCP outlines the planning and reporting of clinical trials that involve human subjects. It’s designed to ensure ethically based practices and establishes a level of scientific quality. Adherence to this means that trial participants are protected as much as possible and that the data from the trial is dependable.

    • Good Laboratory Practices (GLP): Use GLP as part of a quality assurance system. GLP outlines the requirements for non-clinical studies done in a laboratory. These practices protect the research and help verify that the data that’s collected is accurate. Regulations include ethical treatment of animal subjects, type of facilities and equipment used during the studies, and cleanliness.

    There are many other acronyms, such as GSP (Good Storage Practices), GDP (Good Distribution Practices), and GDocP (Good Documentation Practices). Each are all important in their respective activities to ensure frameworks are in place at each step of the lifecycle to protect public health and your business.

    RELATED READING: What is cGMP in the pharma industry?

    What can happen if you don't follow GxP?

    As mandated regulations, not following GxP requirements can lead to severe consequences for your company. Not only are they part of the FDA’s regulatory compliance, but they also help to protect you from adverse events like:

    • Product defects which can lead to recalls
    • FDA Warning Letters
    • Tarnished Reputation
    • Getting rejected by regulatory agencies
    • Excessive customer complaints
    • Fines and forfeitures from regulatory bodies
    • Supply chain issues

    Following GxP has its ultimate benefits: reliable manufacturing, higher product yield, keeping product on the market, fewer complaints, etc.

    Not only is following relevant GxPs required, it's the key to continuous improvement and overall success for any life science organization. This also applies to your entire supply chain, such as contract manufacturing organizations (CMO) and downstream distribution companies. If your entire supply chain isn’t following the basic GxP guidelines, then you open yourself up to compliance risks.

    How to maintain GxP compliance with QMS software

    While it may seem overwhelming to try and read through the vast amount of FDA regulations surrounding GxP and quality management, the good news is that you can streamline your quality processes with quality management software.

    The right software will help you document that GxP practices were followed, establish guidelines for following them, and provide an easily accessible record if the FDA comes to audit you. Some other ways that QMS software can help include:

    • Manage CAPA: A QMS can document any corrective and preventive actions, making it easier to monitor for areas of continuous improvement.

    • Govern document access: You can make sure that only key stakeholders, like managers, can make any changes to documents that contain information about GxP. Also, you can notify those people when a change is made so that they can go in and approve the changes.

    • Maintain FDA 21 CFR Part 11 regulations: This rule addresses the use of electronic signatures, something that needs to be traceable and documented completely. A QMS software should have all the functionality required to facilitate the use of e-signatures.

    RELATED READING: Guide to 21 CFR Part 11 for medical device manufacturers

    Get everything you need to be GxP compliant with Qualio

    If you’re just starting out or you’re struggling to meet GxP compliance, using a QMS software such as Qualio could benefit you. Our software automates many of the tasks associated with GxP, including document approval reminders and e-signature use. You’ll have all the tools you need to help your life sciences company with its quality management goals. We’ll also help you during the FDA audit process, giving you access to our audit experts through Qualio Plus.

    Contact us today for a demo of our eQMS or download our GxP compliance checklist.