GxP Best Practices for Safer, Smarter, Faster Clinical Research
In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.
GxP: An Introduction
The term GxP represents a general abbreviation for “good practice” guidelines and regulations, with the “x” acting as a placeholder relevant to a particular field. Traditionally, based on the clinical research lifecycle, this includes:
- Good clinical practice (GCP)
- Good laboratory practice (GLP)
- Good manufacturing practice (GMP)
- Good pharmacovigilance practice (GPvP)
- Good distribution practice (GDP)
Meeting good practice standards is paramount to the success of potentially lifechanging clinical research; strict adherence to GxP guidelines ensures patient safety and product quality while assisting research teams in meeting critical regulatory requirements for advancing study milestones.
GxP in Clinical Trials
To yield the best possible outcomes for clinical trials, GxP guidelines and compliance regulations assures regulatory agencies the safest and most productive research efforts are being delivered to the market.
Rigorously maintaining GxP compliance standards throughout each phase of the clinical trial process is essential to:
- Protecting the safety and wellbeing of trial participants
- Ensuring the quality and integrity of trial data
- Facilitating the production of beneficial medicines and treatments
Failure to adhere to GxP guidelines and regulations can result in severe and even tragic consequences. Research teams can receive warnings from regulators, on the basis of which they may be required to enact corrective plans and/or to obtain FDA confirmation before resuming development. In more serious instances, sponsors might see their products recalled entirely.
GxP in Medical Devices
It’s no surprise: Developing and manufacturing medical devices is so highly regulated, and this regulatory approach extends to the recent proliferation of medical devices created using artificial intelligence and machine learning (AI/ML). Working together, the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) established a set of 10 principles to guide regulation of such AI/ML-developed devices. These principles serve as a foundation for the advancement of good machine learning practice (GMLP). They also aim to ensure medical devices created through the use of AI/ML are secure, efficient, and maintain a high level of quality.
Device manufacturers must adhere to GMP and GDP, both of which help to ensure:
- Devices are consistently manufactured and stored
- Distributed devices are consistent and of high quality
- Minimized risks to end-user safety and well-being
Violating these GxPs requirements for device manufacturing could result in audit observations, product recalls, loss of revenue, government fines, and legal liability.
Compliance and Regulatory Bodies
Meeting critical study milestones is often dependent on compliance with relevant GxP requirements. Absent GxP guidelines and regulations compliance, clinical research stakeholders’ risk everything from product failure or recall to endangering the lives of trial participants. In the event of GxP noncompliance, stakeholders must absorb the consequences of ceasing operations until GxP violations are remedied.
GxP Challenges and Best Practices
Achieving and maintaining GxP compliance is not easy—it’s a multi-factorial responsibility requiring constant vigilance and assessment. A common challenge for many clinical trial stakeholders involves maintaining adequate GxP documentation – without this, it can result in fines and sanctions. FDA Observation Form 483 pertains to an absence of written procedures and may be used where corrective and preventive actions (CAPA) processes are not adequately defined or followed.
Clinical trial stakeholders should be able to demonstrate their compliance controls have been observed and conformed to, along with identifying and correcting potential non-conformance in end-products. In order to do so, this requires thorough implementation of several GxP best practices: documentation, communication, traceability, and accountability.
GDP is Key to Maintaining Compliance
Want to instill confidence in your GxP? Keep your data and documentation up to date and have controls in place to avoid tampering. GDP also informs regulators that, not only have required activities been undertaken, they’ve also been recorded at the right time.
Follow Record-keeping and Documentation Requirements
Doing so keeps processes trackable and makes it possible to hold companies fully accountable for their data integrity and quality of their end products.
Document Every Critical Action Across Development, Manufacture, and Delivery
For GxP compliance, it is essential to document every critical action made by every employee in the product’s development, manufacture, and delivery. Make sure this documentation is auditable and is comparable to the risk posed by non-conformance.
Quality Management Systems Support GxP Compliance
For several GxP categories, a key best practice for maintaining compliance is implementing a quality management system (QMS).
- GLP ensures the quality and integrity of non-clinical laboratory studies that support research for products regulated by government agencies. A QMS ensures laboratory-run studies are planned, performed, monitored, recorded, archived, and reported under the right conditions and in a consistent and repeatable manner.
- For GMP, the rules for regulation differ depending on the country. However, GMP requires products are consistently of high quality, are appropriate for intended use, and meet requirements for clinical trial authorization.
- GPvP ensures companies continue to monitor the safety of the medicines they have developed after they have been launched in the market. GPvP best practices include maintaining a QMS capable of storing huge quantities of safety data used to monitor and report on the safety of potentially marketable drugs.
- Finally, GDP governs the wholesale distribution of medicines, keeping products safe and in usable condition for consumers. GDP provides distributors with auditable systems to ensure safe storage and transport, contamination prevention, and recall management, while helping make certain only authorized products enter the distribution network. Using a QMS encourages greater accountability, traceability, and cooperation throughout the supply chain.
Future Trends and Innovations
The processes for achieving and maintaining compliance with GxP guidelines and regulations are increasingly subject to modernization. In clinical trials, for example, documentation processes can become streamlined through the use of eSolutions such as an electronic trial master file (eTMF). This allows all regulatory documents, whether originating with a sponsor or at a site, to be managed, signed, and securely exchanged to relevant stakeholders for long-term storage in an eTMF, while providing shared access amongst its users.
Similarly, clinical trial management systems (CTMS) have revolutionized the way researchers can conduct and manage clinical studies effectively. Because trials are becoming more complex, a CTMS is integral to maintaining a thorough and transparent process and facilitating GxP compliance efforts. Many CTMS platforms can optimize finances, assist with regulatory compliance, and streamline overall clinical research operations for all types of research sites, site networks, hospitals, and health systems.
Overall, the most impactful solutions will be those enhancing how researchers can maintain thorough organization of documentation, achieve quality data management, and keep robust oversight capabilities through each phase of clinical study. This all helps keep study teams on track towards producing impactful beneficial medical treatments and medical devices.
Making Clinical Research Safer, Smarter, and Faster
GxP programs can be complex and difficult to manage. GxP guidelines and regulations are in place to ensure the highest quality and most reliable end products are delivered to patients without compromising their wellbeing.
For life science organizations, prioritizing GxP regulations compliance can accelerate therapies to market, all while making your clinical research safer, smarter, and faster in the process.