Good Manufacturing Practice (GMP) compliance in biologics contract manufacturing underpins product safety, efficacy, and ...

The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good ...

Advancing small molecules from R&D to GMP requires coordinated strategies to support phase I clinical manufacturing.

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 ...

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 ...

Regulators stress accountability: FDA and EU frameworks require sponsors to maintain oversight of CDMOs, treating outsourcing as an extension of the pharmaceutical quality system. Quality control as ...

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 ...

The key market opportunities include enhanced GMP implementation for improved efficiency and compliance in the pharmaceutical industry, leveraging technological advancements, and adapting to rigorous ...

Opportunities exist in enhancing skills for pharmaceutical GMP auditing, a key function ensuring compliance with USFDA and ICH Q10 standards. This training targets professionals keen on bolstering ...

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 ...

Continuous monitoring ensures contamination control and GMP compliance in pharmaceutical cleanrooms, supporting sterility and ...

The European Commission wants feedback from stakeholders on updating its good manufacturing practice (GMP) guidelines in EudraLex Volume 4 to account for recent advances in artificial intelligence (AI ...