The use of cGMP software systems in regulated industries has come a long way. Similarly, the concept of Good Manufacturing Practice (GMP) earned its place in regulated industries the hard way over a period of several decades.
Consumer safety problems - such as the deaths of 107 people in the United States in 1937 caused by the antibacterial drug Elixir Sulfanilamide and the thousands of birth defects in 46 countries in the late 1950s and early1960s due to the sedative Thalidomide - forced authorities worldwide to establish GMP regulations. Over the years, GMP principles evolved into the Current Good Manufacturing Practice (cGMP) standards that exist today. Pharmaceutical, medical device, and other regulated industries increasingly use cGMP software to comply with the regulations.
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The U.S. FDA's regulations for pharmaceutical, medical device, blood and biologics, and other regulated industries embody the cGMP principles that are widely followed throughout the world today. These regulations are also the basis of cGMP software available in the market today. The FDA's 21 CFR Parts 210-211, which apply to pharmaceutical companies, are a good example of how cGMP principles help ensure product quality and consumer safety. The regulations cover every aspect of drug development and manufacturing, from personnel to processes to distribution. Likewise, a cGMP system must cover all of those aspects for compliance purposes.
The FDA took its cGMP initiative further when it released the "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach" in 2002. The initiative examined cGMPs as they applied to modern technological advances in the pharmaceutical industry. It was also meant to harmonize the FDA's efforts on quality improvement with its international counterparts. The risk-based approach has since become the basis of cGMP software solutions widely used in the industry today.
ISO quality standards are used by general manufacturers throughout the world. These standards are designed to ensure product quality and processes, just like the cGMP regulations enforced by the FDA. However, they differ in their target audiences and specific requirements. Companies that comply with both FDA rules and ISO standards must develop a cGMP system that addresses both.
For medical device manufacturers, there is an overlap in cGMP and ISO requirements. ISO 13485:2003 is a quality standard that applies to medical device companies. 21 CFR Part 820 (Quality System Regulation or QSR) is the GMP regulation for medical device companies enforced by the FDA. The FDA has harmonized QSR with ISO standards, making them complementary. In looking for cGMP software, companies should make sure that the solution they choose addresses both GMP and ISO 13485 standards.
MasterControl quality and compliance software addresses cGMP requirements and is widely used by regulated companies as cGMP software and platform for a compliant cGMP system.
MasterControl's cGMP software can automate all quality processes critical to compliance, including document control, change control, CAPA, training management, and audit management, among others. Here are some of the benefits of using MasterControl as the foundation of your cGMP system:
To learn more about MasterControl's cGMP software systems, contact a MasterControl representative.