FDA FINDS LABORATORY CONDUCTING STERILITY AND ENDOTOXIN TESTING FOR COMPOUNDING CENTERS HAS SIGNIFICANT ISSUES WITH STERILITY ASSURANCE The FDA recently audited Front Range Laboratories, Loveland, CO from August 5 through August 30, 2013. Their five investigators issued a five Observation, twelve page document. Enclosed is Observation 1 which … [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...]
FREQUENTLY ASKED QUESTIONS — USP GENERAL CHAPTER (REVISED)
Microbial Examination of Nonsterile Products: Microbial Enumeration Tests USP <61> Q. Can I use strains other than those that are cited in the USP? A. You should use the strains that are cited in this chapter or equivalent strains from other culture collections. For example, if Pseudomonas aeruginosa ATCC 9027 is indicated, you should use this strain or strains … [Read more...]
FDA ISSUES — MEDIA GROWTH PROMOTION STUDIES McNEIL-PPC, DELTEX PHARMA, RIBBON PHARMA & CHEMICAL, COLUMBIA PRESBYTERIAN MEDICAL CENTER
FDA ISSUES -- MEDIA GROWTH Â PROMOTION STUDIES McNEIL-PPC, DELTEXÂ PHARMA, RIBBON PHARMAÂ & CHEMICAL, COLUMBIA PRESBYTERIAN MEDICAL CENTER Comment Comments Regarding Proposed Changes to USP General Chapter <823> Radiopharmaceuticals for Positron Emission Tomography-Compounding were recently made to the USP as they move forward in … [Read more...]
