GMP Quality & FDA Requirements
The U.S. Food and Drug Administration (FDA) enforces regulations for pharmaceutical, medical device, blood and biologics, food, and other regulated industries. Those regulations embody Good Manufacturing Practice quality principles. The FDA also provides guidances that reflect GMP quality standards and offer a framework for compliance.
Of all the GMP quality-related regulations enforced by the FDA, perhaps these two are the most important and have the most impact:
- 21 CFR Parts 210-211, which apply to pharmaceutical companies, embody Good Manufacturing Practice quality principles that cover every aspect of drug development and manufacturing, from personnel to processes to distribution.
- 21 CFR Part 820 (Quality System Regulation or QSR) is the GMP quality regulation for medical device companies. It requires device manufacturers to establish controls in design, document, manufacturing, and production processes.
GMP Quality & ISO Requirements
A wide range of manufacturers throughout the world voluntarily adhere to ISO 9000, a series of GMP quality standards, because most companies prefer suppliers and providers with ISO certification. ISO 9000 applies to most manufacturers but there are other ISO standards specially developed for certain industries.
For example, ISO 13485 and ISO 14971 are the most widely recognized GMP quality standards for producing medical devices. These standards are voluntary, but regulatory bodies throughout the world encourage and expect medical device manufacturers to follow them to ensure Good Manufacturing Practice quality in all aspects of their operations.
ISO 13485 focuses on the creation and maintenance of a quality management system, while ISO 14971 provides risk management guidelines that apply specifically to medical devices. Together these standards help manufacturers implement processes that comply with regulations pertaining to Good Manufacturing Practice quality.
How MasterControl can Help You Attain and Maintain GMP Quality
MasterControl quality and compliance software helps companies throughout the world in complying with GMP quality regulations and standards. It is an end-to-end solution that automates and connects all quality processes for a holistic approach to regulatory compliance.
Here is how MasterControl helps companies attain and maintain compliance with GMP quality regulations.
Framework for Quality Management System:
FDA, ISO, EU directives, and other regulatory requirements pertaining to Good Manufacturing Practice quality require the establishment of a quality management system, including quality procedures that are documented, controlled, and maintained. MasterControl provides a framework for a company’s quality management system. Its web-based platform automates routing, review, and approval of documents- and forms-based processes, and provides a single location for all documents.
Integrates Risk Management in All Processes:
MasterControl integrates risk management within the QMS by providing robust tools to make sure that every process contributes to a company’s overall risk management efforts. Risk management tools such as analytics and reporting tools, risk matrix, and risk assessment forms (for every project) will help mitigate risk factors and ensure compliance with GMP quality regulations.
Connects All Critical Processes:
With MasterControl, a company can connect all critical processes such as document management, training control, CAPA, nonconformance, and audit management processes. This connectivity will help ensure that quality and other issues will not fall through the cracks. Connectivity also facilitates compliance with GMP quality regulations by making it easier for all affected employees to participate in quality processes.
For More Information on quality and compliance software
For more information about quality and compliance, and how our software can help your company meet current good manufacturing practices, please feel free to contact a MasterControl representative.