A NEW PROPOSED USP GENERAL INFORMATION CHAPTER USP recently released a new DRAFT in a much anticipated area that has gained significant attention over the past half dozen years. The subject, "USP<1115> Bioburden Control of Nonsterile Drug Substances and Products", has generated much controversy as … [Read more...]
SOUTH DAKOTA PHARMACEUTICAL RECEIVES WARNING LETTER (3/17/11)
FDA CITES DAKOTA LABORATORIES FOR FAILURE TO ADEQUATELY VALIDATE ASEPTIC PROCESS Comment Excerpts and comments from specific violations follow. Please obtain the complete Warning Letter from FDA's web site. CGMP Your firm has not established appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile … [Read more...]
