Audits and adherence to dynamic regulations have posed serious challenges for various pharmaceutical organizations. To list down the forthcomings of pharma audits, FDA warning letters and compliance adherence letters are endpoints, thereafter the compliance bridging is in the hands of pharmaceutical companies. Amongst such compliance letters, Form 483 issued by the US FDA remains frightening for any pharmaceutical establishment.
GxPs are standardized practices defined for drug companies that research, produce, store, distribute or sell pharmaceutical products. GxPs refer to a collection of quality standards and guidelines that are designed to ensure that the safety of the products is maintained across the product lifecycle. While there is no single framework for GxP guidelines and regulations, some of the common regulators include FDA in the US, TGA in Australia, and HC-SC in Canada.
There are different types of GxPs that Pharma companies must follow, which span across: