The Drug Regulatory Authority of Pakistan (DRAP) has finalized its first set of consolidated guidelines on good manufacturing practices (GMP), overhauling a section on quality control since releasing ...

EMA said that the Q&A is not meant to set new GMP requirements but rather to give guidance on “what principles of GMP mean and how to implement them.” The guideline describes “minimal” requirements in ...

FDA tied AI-assisted drafting directly to established Quality Unit accountability under 21 CFR 211.22(c) for approving/rejecting specifications and procedures affecting identity, strength, quality, ...

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 ...

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 ...

A revision of the EU GMP Volume 4 Annex 1 was issued in August 2022, introducing new regulations for sterile drug products and production. This release replaced the 2020 draft and 2008 version, adding ...

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 ...