COMMENT Each year CDER summarizes the number of significant Observations obtained from Form FDA 483s. Enclosed are the "top fifteen" Observations. The Observations within the top fifteen usually do not change — although their frequency and ranking may vary. Please note that the frequencies of various Observations have … [Read more...]
PYROGEN AND ENDOTOXIN TESTING: QUESTIONS AND ANSWERS (06/12) JUST ISSUED
The FDA just published their final Guidance for Industry Pyrogen and Endotoxin Testing: Questions and Answers. FDA has determined that previously published USP and AAMI documents describing methods and calculation of pyrogen and endotoxin testing limits provide industry with appropriate information. However, because the compendial chapters and standards do not address certain … [Read more...]
FREQUENTLY ASKED QUESTIONS — USP GENERAL CHAPTER 62, PART I (REVISED)
COMMENT The USP has recently released a Summary of Frequently Asked Questions (FAQ) for both USP <61> and <62>. The FAQ for USP <61> was previously posted in another Blog. The FAQ listed below is the first of two Parts discussing additional FAQ from USP <62>. Additional FAQ will be posted later in the week. Microbial Examination of Nonsterile … [Read more...]
FDA CBER STERILITY TESTING REQUIREMENTS (610.12) AMENDED (06/04/12)
ELIMINATES SPECIFIED STERILITY TEST METHODS, CULTURE MEDIA FORMULAE, AND CULTURE MEDIA TEST REQUIREMENTS -- CLARITY OR CONFUSION? Summary (Effective June 4, 2012) The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages … [Read more...]
FDA CDER PUBLISHES SEVERAL NEW PRESENTATIONS TO ASSIST WITH REGULATIONS GOVERNING PET DRUG PRODUCTS
DOCUMENTS INCLUDE AN EXTENSIVE SLIDE DECK AND PROPOSED Q & A The FDA has been quite busy since the issuance of the new 21 CFR 212 entitled "Current Good Manufacturing practice for Positron Emission Tomography Drugs" (December 2011) which covers Positron Emission Tomography (PET) Drug Products. CDER has issued a new Draft Guidance as well as a slide deck from B. Uratani, … [Read more...]
