Good Manufacturing Practice (GMP) is a set of FDA regulations, ensuring minimum quality requirements are met during the manufacture and testing of medical devices, active pharmaceutical ingredients, diagnostics, foods and pharmaceutical products. Both production and quality control functions are covered by GMP standards.
WHY IS IT IMPORTANT AND HOW DOES IT AFFECT YOUR LABELING SOFTWARE?
GAMP® procedures were created in response to the evolving regulatory requirements imposed by the FDA and other regulatory bodies, concerning the validation of computerized systems, providing a framework for ensuring GMP compliance. They provide pragmatic and practical guidance for the validation of software used in production and quality control processes, taking a risk-based approach.
Each stage of the manufacturing process is evaluated under GAMP®, requiring Standard Operating Procedures (SOPs) for all processes that can affect the quality of the finished product, including labeling.
HOW CAN PRISYM ID HELP?
The latest version of GAMP® (GAMP® 5) explicitly directs regulated organizations to leverage the expertise and documentation of the software vendor. The PRISYM 360 cloud-based labeling solution was purpose-built for use in the medical device and clinical trial industries and each software release is supplied with a full validation documentation pack that demonstrates the robustness of the software alongside extensive function specifications.