Manufacturers are usually subjected to a diverse variety of regulations typically established by international and regional bodies. Failure to comply can result in the loss of authorization and ...

As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article is one of a series of ...

Food safety has been regulated across the world for as long as large-scale food production has been in place – since the mid-1800s in the United States, for example. Resulting from a long history of ...

GMP release and stability testing are indispensable elements of the pharmaceutical sector’s quality assurance strategy. These testing protocols not only ensure that pharmaceutical products are safe ...

To meet the requirements of regulatory agencies, pharmaceutical products are produced in a controlled setting. One example of such a controlled environment is a cleanroom, which is used to minimize ...

Multiple departments, including engineering and quality assurance, are responsible for evaluating GMP equipment and facilities. Regulatory inspectors require well-organized, preferably digital, ...

Good Manufacturing Practice (GMP) is a system or protocol for ensuring product safety and consistency according to quality standards. GMP is important in all manufacturing industries, though it is ...

On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule 1 amending the device good manufacturing practice (GMP) requirements of the Quality System Regulation (QSR) 2 ...

As a background summary, CGMP represents the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). CGMP guidelines provide for systems that give ...

Our Cell Processing Facility (CPF) is a Good Manufacturing Practice, or GMP, bioprocessing manufacturing facility that supports the reproducible production of human hematopoietic or immune-competent ...