FDA announces Experiential Learning Site Visit Program
The U.S. Food and Drug Administration (FDA) is announcing the Fiscal Year 2025 CDER Office of Pharm…
The U.S. Food and Drug Administration (FDA) is announcing the Fiscal Year 2025 CDER Office of Pharm…
corrective action and preventive action (CAPA) according to your procedure until after FDA cited yo…
The USP has issued a Notice of Intent to Revise General Chapter <621> Chromatography. Based o…
The significant violations of CGMP regulations for finished products, which are mentioned in the Wa…
From 6 February to 15 March 2024, the FDA inspected the pharmaceutical manufacturing facility of Wi…
In a recent Warning Letter, the FDA has criticised inadequate equipment qualification and deficienc…
When planning new purified water (PW) systems, the question arises as part of the risk analysis or …
Swiss medic took new step towards its own database to post GMP/CDP certificate The Swiss health au…
Additional substantive information I. Background The FDA uses the term ‘peptide’ in this notice to …
The U.S. Food and Drug Administration (FDA) issued a Warning Letter dated 03 September 2024 to a Ca…