What are the FDA's Good Manufacturing Practice Guidelines?
The FDA devised cGMP, or Current Good Manufacturing Practice regulations, as a means to establish a foundation for drug product quality. These good manufacturing practice guidelines are enforced by the FDA in order to ensure that life science companies are utilizing systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adhering to good manufacturing practice guidelines, as the FDA states in its Facts About Current Good Manufacturing Practices, “assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.” Quality management systems, or QMS, are crucial to maintaining “adequate control” at even the most basic level. The good manufacturing practice guidelines are minimum requirements that are flexible enough to allow manufacturers to make decisions based on their individual organizational needs in regards to the best methods of implementing the necessary controls according to scientifically sound processing methods, testing procedures, and design.
Why are Good Manufacturing Practice Guidelines Important?
Can you tell just by looking at a pill if it will work or not when you swallow it? Does it smell like it has spoiled? As consumers, we usually can’t detect with our senses whether or not a drug product will work or if it is safe. Good manufacturing practice guidelines exist to help ensure that drug products are safe and that they work as they are supposed to. According to the FDA, drugs must be “manufactured under conditions and practices required by the cGMP regulations to assure that quality is built into the design and manufacturing process at every step.” To make certain that good manufacturing practice guidelines are followed, the FDA enforces cGMP regulations by monitoring manufacturers’ facilities (to check that they are in good condition), equipment (to see that it is properly maintained and calibrated), employees (to make certain that they are qualified and fully trained), and processes (to ensure they are reliable and reproducible).
MasterControl Software Solutions Can Help Your Company Maintain Consistent Compliance with Good Manufacturing Practice Guidelines
For more than two decades, MasterControl has provided hundreds of companies around the world with quality management software solutions that help them achieve and maintain compliance with good manufacturing practice guidelines. MasterControl software has been specifically designed to help companies doing business in regulated environments with quality management issues such as:
- Documents Management: MasterControl software automates the entire lifecycle of all documents-based processes, including task assignment/routing, follow-up, tracking, escalation, review, and approval. It automates and efficiently manages document control processes to help ensure compliance with FDA 21 CFR Part 11 regulations, ISO quality standards, and other similar regulatory requirements.
- Training Management: MasterControl automates the assignment and monitoring of training tasks and grading of online exams to assure compliance with good manufacturing practice guidelines. The software allows sequencing of training courses, so that after a prerequisite course is completed, the next course is automatically launched. The software also provides a group sign-off feature for verifying the training of large groups of employees. Training management can be integrated with the rest of the quality system to ensure implementation of good manufacturing practice guidelines, so that any change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change.
- CAPA and Quality Events: An effective corrective and preventive action (CAPA) software system improves product quality and safety, increases customer satisfaction, and, more importantly, ensures compliance with global standards such as the good manufacturing practice guidelines set forth by the FDA. MasterControl CAPA connects quality events such as nonconformance, deviations, and customer complaints while automating the management of the entire CAPA process, from initiation to investigation and all the way through closure. The system allows a CAPA form to be automatically launched from another form (such as a customer complaint) in order to streamline the CAPA process and avoid human data entry errors.
- Audit Management: Quality audits are required on an ongoing basis to help improve product quality and safety and to ensure compliance with good manufacturing practice guidelines. MasterControl enables efficient execution of audits, streamlines the capture and management of findings and responses, facilitates the effective planning and scheduling of audits and resources, and simplifies the reporting on resulting data.
These are just a few of the quality management processes that MasterControl software solutions are designed to streamline. For a more comprehensive list of MasterControl offerings, visit the Solutions page on the MasterControl website.
Learn More About Good Manufacturing Practice (GMP) Guidelines
For more information about GMP guidelines and to find out how our software can help your company meet current good manufacturing practices, contact a MasterControl representative at 801-942-4000 or visit MasterControl’s Resource Center for free white papers, webinars, and other informative downloads.