Pharmaceutical companies face some very real challenges within clinical quality management. There are pressures to not only to ensure compliance but to get approved drugs to market safely and effectively without spending additional funds on redundant quality management tools that may already exist in their organization. One way to address these challenges would be for pharmaceutical companies to create a global GxP solution that ensures visibility across the supply chain as well as automate quality processes, sufficient tracking of all correspondence, and more.
All too often, GLP, GCP, and GMP systems are separated, causing problems that could affect the supply chain on many levels. GMP systems are generally in place, but GLP and GCP systems are often ignored and remain manual or disparate. With an EQMS solution, like TrackWise, this siloed way of operating can stop. To begin our discussion, though, we must first discuss GxP and why many of its phases are very similar and how we can leverage their differences to create a global GxP solution.
Good Laboratory Practices (GLP)
GLP starts with pre-clinical or laboratory practices. At this stage, organizations begin to identify compounds to develop a drug, or materials to create a device, which are laboratory focused and not on any human subjects. They must follow FDA’s 21 CFR 58 guidelines. Companies are looking for and identifying compounds that could make it to clinical trials. This initial cycle could last five to seven years and start with as many as 5000 compounds. By the time the drug reaches the clinical phase it might only include 5 compounds.
A major part of the pre-clinical practice is master schedule management and audits. These activities are very time and labor-intensive, and most organizations use manual processes to manage these very important procedures. Master schedule management becomes much less of a burden when automated, simplifying approvals and managing events off that schedule electronically.
Good Clinical Practices (GCP)
The second phase of the drug/device development cycle is GCP, which could take anywhere from 6 to 8.5 years to tweak the product to perfection. That is the time when the compound or device has been proven in the lab and is now ready for testing on human subjects. This needs to be in alignment with E6 guidelines for GCP.
In accordance with ICH Guidelines, a key term for source document validation (SDV) is when incidents arise during monitor reports that could preempt an audit of a site, and can lead to serious adverse events. Those critical events need to be tracked and managed.
Good Manufacturing Processes (GMP)
The third and final phase of the drug development cycle is GMP. This is when the drug has gone from a soup to a standard recipe by adding ingredients and tweaking the formula and consistently replicating it in a manufacturing facility. A quality management system (QMS) is typically implemented for GMP when a company has decided it wants to automate its quality processes. Across the entire organization, from preclinical through clinical to manufacturing of an approved drug or device, these quality processes are necessary to ensure compliance and patient safety by identifying, tracking and managing events to resolution. A QMS is typically used in manufacturing facilities specifically to record, track and manage events on the manufacturing floor, i.e. the cap to a bottle is not closing tight enough.
The Transition to a Global GxP Solution Begins with Audit Management
The most efficient way to transition from a GMP quality management system to a global system across GxP is by leveraging audit management. This is because many of the processes and workflows are similar, but the terminology is different. The audit cycle begins with planning and is followed by execution, and follow-up. Throughout the cycle, we see a microcosm or sampling of what's wrong with a quality management system that doesn't apply an automated, centralized solution. Planning is usually manual, reporting is lacking, follow-up is delayed because the process is too cumbersome, and users are confused or intimidated by the solution in place.
By harmonizing all auditing processes with an enterprise quality management system (EQMS) like TrackWise, GxP audit management is configurable to account for differences in processes or terminology that applies specific organization and or regulation. In addition, a holistic audit management system promotes standard metric reporting as well as greater flexibility, automation, and consistency.
To learn more about TrackWise and how EQMS can help a pharmaceutical organization transition its GMP system to a global GxP solution, please visit www.spartasystems.com. You can also review our Pharmaceutical/Biotech industry page for more information about how pharmaceutical organizations have implemented TrackWise to improve their quality and compliance processes.
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