FDA Creates a Tool to Make it Easy to Find GMP Guidelines
(Thursday, January 11, 2024)
FDA publishes a lot of guidelines to assist the industry, on its website. But since FDA’s website has more than a million pages, by some accounts, finding all relevant documents on the FDA’s website is no easy task. To make it easier for GMP manufacturers, the FDA published a new page on its website with a searchable library of 245 documents related to manufacturing issues.
The FDA guidelines come in various formats such as guidance documents, presentations, and articles, but officially three kinds of documents have broadly applicable authoritative information: Guidance Documents, MAPP (FDA’s internal SOPs), and Compliance Inspection Programs. And it is these three that are compiled on the new webpage. The documents are sorted into 21 categories ranging from generic topics such as GMP and ICH to specific topics such as Public Health Emergency and microbiology.
While there is no new information on this page, all the information found on it can also be found by other searches on the FDA website and by Google searches; this is a very useful tool for finding certain kinds of information quickly. For example, Guidance Documents can be found on FDA’s page for “Guidance Documents” but this new page only displays documents related to specific GMP issues. MAPPs are hard to find, in general, and compliance inspection program descriptions are spread throughout the main FDA website. So, this new webpage would save precious time and presumably be updated frequently to keep it current.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC