Are Your IT Systems GxP/GMP Compliant?

GxP and GMP are two distinct practices relating to Quality. While GMP stands for Good Manufacturing Practice, GxP stands for Good and Practice, with the middle ‘X’ for any variable relating to the industry with which it is associated, such as Manufacturing, Clinical, IT, Storage or any other). GxP is a fluid term that represents regulations set out by the FDA for various industries and codified in the Code of Federal Regulations (CFR). The set of rules that govern these disparate industries are often called Predicate Rules.

GMPs (or cGMPs, to denote “current” or the latest) are set out and enforced by the FDA to ensure that manufacturing processes and facilities that manufacture products in the pharma, medical devices, food and beverages, and cosmetics industries are properly designed, are continually monitored, and are in a state of control in accordance with prescribed standards. 

By requiring manufacturers to adherence to the cGMP regulations; the FDA seeks to ensure that manufactured products have the necessary strength, quality, identity, and purity, and that they are safe for consumption and meet the requirements of intended use.

Quality Management Systems and their components

Quality Management System is the means through which products in the regulated environments meet their intended use. 

QMS has four core components:

o    Quality Planning

o    Quality Assurance 

o    Quality Control

o    Quality Improvement

QMS guidelines are designed in such a way that they allow the individual manufacturers to meet the QMS requirements that suit them best. A GMP audit is the method through which compliance with GxP and GMP regulations of met.

Documentation is at the core

One of the cornerstones of GxP and GMP audits is documentation. The FDA is very clear about this requirement. It goes by the dictum, “if it is not documented, it did not happen”. this sums up the importance of documentation to GMP audits through which GxP and GMP regulations are met. One other way of understanding the criticality of documentation is by the consequence of lack of proper documentation: the FDA can shut down a facility that fails to put the required, proper documentation in place.

In addition to regulations for manufacturing; the FDA also has GMP requirements for Information Technology (IT). Not only should a drug produced in a GxP/GMP compliant manner follow prescribed Information Technology practices; even computer systems that are involved in developing, manufacturing and selling of regulated products should do so.

The formal process through which changes introduced into a product or a system are done so in a controlled and coordinated manner and documented is what is called Change Control. Proper Change Control is required from manufacturers into their QMS and IT systems.

Full and thorough learning

A thorough understanding of these complex concepts relating to GMP regulations that require a documentation management system to issue, manage and control all documentation.

Download Brochure - IT Systems GxP/GMP Compliant

That has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

For More Information  
FDA Import