Pharmacopeial Forum (PF, September/October 2018, 44(5)) published a new, proposed General Chapter (USP<60>) on B. cepacia Complex entitled “USP<60> Microbiological Examination of Nonsterile Products—Tests for Burkholderia cepacia Complex”. The proposed PF chapter represents an expansion of USP<62> Microbiological Examination of Nonsterile Products: Tests for … [Read more...]
Microbial Limits / Specified Microorganisms Rationale
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...]
2015 United States Pharmacopeia (USP) Microbiological Training Program — 9-Part Live Training Program Instructor: Barry A. Friedman Ph.D.
STARTS THURSDAY, MARCH 19, 2015 The United States Pharmacopeia (USP) contains a number of chapters relating to microbiology within its General and General Information Chapters. These Chapters present information that relate to both non-sterile and aseptic processing. Several of these chapters have been recently updated and all have been updated since 2009. Each of these … [Read more...]
TESTING LABORATORY RECEIVES STERILITY OBSERVATIONS
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...]
BAXTER HEALTHCARE CORP RECEIVES SINGLE WARNING LETTER FOR TWO LOCATIONS (05/31/13) — PART II
WHEN IS PARAMETRIC RELEASE USING TERMINAL STERILIZATION NOT STERILIZATION 3. "Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to … [Read more...]
