As a “Frequently Asked Questionâ€, the USP is often queried about the determination of microbial limits and specified microorganisms. The following, obtained from USP, provides a clarification for this commonly asked question. In determining the appropriate microbial limit, the USP Microbiology Expert Committee considers such matters as the … [Read more...]
FREQUENTLY ASKED QUESTIONS — USP GENERAL CHAPTER 62, PART II (REVISED)
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 second of two Parts discussing additional FAQ from USP <62>. Q. Why shall I use the shortest incubation period? A. You have to show that the worst conditions … [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...]
MIRAMAR COSMETICS RECEIVES WARNING LETTER (AUGUST 18, 2011)
WARNING LETTER IS RECEIVED FOR REPEAT VIOLATIONS AND OBJECTIONABLE (SPECIFIED) MICROORGANISMS COMMENT Miramar Cosmetics of Doral, Florida received a Warning Letter for repeat violations from 2007, the presence of objectionable (“specified”) microorganisms, responding after 15 business days after the Form FDA 483 was issued and the manufacturing of drugs without an approved … [Read more...]
