GMP Regulations and GxP Software
The FDA enforces GMP regulations for the pharmaceutical industry (21 CFR 211) and medical device industry (21 CFR 820, also known as Quality System Regulation). The concept of GMP is also incorporated in the FDA's "GMP Guidelines and Inspections Checklist," based on the Federal Food, Drug, and Cosmetic Act. Most GxP software solutions address these regulations.
The GMPs for pharmaceutical and medical device companies are applicable to the entire process of development and manufacture of products including design, manufacture, packaging, and labeling. If your company is evaluating GxP software solutions, be sure to look for a solution that addresses these different processes.
Many manufacturers seek ISO certification to position their products and services in the global market more competitively. Just like the FDA's GMP regulations, the overall goal of the ISO 9000 series for general manufacturers and ISO 13485 for medical device companies is to ensure safe and high-quality products and services. Manufacturers are increasingly relying on GxP software when they establish a quality system for the purpose of both FDA and ISO compliance.
The FDA has harmonized QSR with ISO standards, making them complementary. In looking for GxP system, companies should make sure that the solution they choose addresses both GMP and ISO standards.
GCP, GLP, GCLP Requirements and GxP Software
Manufacturers usually establish a GxP system with GCP requirements in mind, either by utilizing software or a traditional, paper-based system. When manufacturers create a GxP system, it is likely that they are addressing the requirements of any or all of the following GCP regulations and standards for conducting clinical trials:
- The FDA's Good Clinical Practice (GCP) regulations refer to a group of regulations pertaining to various aspects of executing clinical research for new medicines.
- The International Conference for Harmonization (ICH) has also developed a number of GCP guidelines for designing and conducting clinical trials for new medicines.
- ISO 14155:2011 (Clinical Investigation of Medical Devices for Human Subjects: Good Clinical Practice) offers international standards for protecting the rights of patients and defining the responsibilities of sponsors and clinical investigators.
- The FDA enforces 21 CFR 58 (GLP for Nonclinical Laboratory Studies), which covers animal studies that support R & D for products regulated by the FDA. The FDA also enforces 42 CFR 493 (Clinical Laboratory Improvement Amendment or CLIA), which regulates the safety and effectiveness of clinical laboratory diagnostic testing (for humans). CLIA is based on similar GMP and GLP principles. A laboratory establishing a GxP system typically has specific requirements in mind. In evaluating GxP software solutions, be sure to choose features that address the requirements that your laboratory complies with.
- The WHO's GCLP (Good Clinical Laboratory Practice) guidelines identify systems and procedures for organizations that process specimens from clinical trials. The guidelines offer a framework for clinical laboratories complying with GCP regulations and standards.
How MasterControl's GxP Software Solutions Can Help You
MasterControl GxP software solutions address GMP, GCP, GCLP, GLP, and CLIA requirements, making it an ideal foundation for any GxP system. MasterControl offers the following solutions:
- MasterControl Documents: It automates routing, follow-up, escalation, and approval of SOPs and other critical documents, greatly increasing a laboratory's efficiency. MasterControl is web-based so it is accessible to all authorized users from virtually anywhere 24/7. It provides robust document control capability, an essential GxP software component that can serve as a centerpiece for your GxP system.
- MasterControl Training: This module automates distribution and monitoring of training tasks, as well as online grading of tests. Unlike other GxP software solutions, MasterControl Training has the capability to sequence training, so a trainee who completes a prerequisite course will automatically get the next training.
- MasterControl CAPA: This module is ideal for companies switching from a manual GxP system to an automated system. It offers industry best-practice forms that help reduce error in data entry. It streamlines the CAPA process by giving users the capability to launch a CAPA form another form, such as nonconformance or deviation.
- MasterControl Change Control: Change control is a fundamental aspect of any effective GxP system. MasterControl facilitates initiating a change control action with the help of a best-practice form that incorporates priority level, risk assessment, and classification of the change.
- MasterControl Audit: This module streamlines the audit process by automating all audit-related tasks and schedules and providing robust tools for managing and conducting regular audits. A key advantage of MasterControl over other GxP software is its capability to connect the audit management process with all critical GxP system processes.
For More Information on GxP Software
To learn more about MasterControl GxP software systems, please feel free to contact a MasterControl representative.