The Committee on Publication Ethics (COPE) was established in 1997 to address research and publishing ethics violations. Its goal was to identify workable solutions to the problems and create best practices. It is a non-profit organization that offers a discussion forum and guidance to scientific editors. The guidelines were developed from a prototype drafted by individual committee members and then circulated for extensive comment. These guidelines are meant to be advisory rather than mandatory and change over time.
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:
The medical devices industry is considered highly regulated hence device manufacturers must adhere to a strict set of practices, known as, GxP or Good Practices (GMP - Good Manufacturing Practice, GDP - Good Distribution Practice, GLP - Good Laboratory Practice, GCP - Good Clinical Practice and many more).
Over the decades, with the inception of strict Regulatory regimes, life sciences companies have launched numerous medicinal products in the market prioritizing the end user’s safety. But only few have remained popular sustaining the market competition while many fail to break the initial Regulatory barriers because of incompliant practices.