A New Draft Guidance on FDA Expectations for Cosmetic GMP
Scott Sutton, Ph.D. Microbiology Network, Inc. There is a good deal of interest from FDA in the cosmetics industry and the Quality systems in place at manufacturing facilities. The
View ArticleThe Compendial Draft Chapter on “Bioburden Control of Nonsterile Drug...
USP Chapter 1115 Pharm Forum 39(4) July/August 2013. Scott Sutton, Ph.D. Microbiology Network, Inc. The long-awaited USP draft of a newly proposed chapter – <1115> Bioburden Control of Nonsterile
View ArticleAlphabet Soup: Abbreviations and Acronyms of Interest
Scott Sutton, Ph.D. One of the more challenging aspects of that first job, or starting a new job in a new company, is in learning the corporate culture. The
View ArticleThe Compendial Sterility Tests
Scott Sutton, Ph.D. Microbiology Network, Inc. Note: The opinions expressed in this blog are those of the author and should not be interpreted as the positions or policies of USP
View ArticleDraft Revision to Antimicrobial Effectiveness Test Released by USP
Scott Sutton, Ph.D. Microbiology Network, Inc. Note: The opinions expressed in this blog are those of the author and should not be interpreted as the positions or policies of USP
View ArticleMicrobiology Custom Dictionaries
Scott Sutton, PhD Ziva Abraham MicroRite and the Microbiology Network present a listing of specialized words and terms for assistance in technical writing for the microbiologist. These files may be
View ArticleBET Assay Interferences and Their Impact on Endotoxin Recovery
Karen Zink McCullough MMI Associates BET scientists have known for years that product matrices can significantly interfere with the detection of endotoxin in drug products. In fact, FDA and
View ArticleEndotoxin Concentration, Endotoxin Potency and Bacterial Number
Michael E. Dawson, Ph.D., RAC Director of Regulatory Affairs Associates of Cape Cod, Inc. The question is often asked, how many bacteria does it take to make one Endotoxin Unit
View ArticleThe Challenges of Crossing Regulatory Borders
by Gemma Verma Many pharmaceutical companies perform their research and manufacturing operations across international borders, and ship their goods to people around the world. However, operating...
View Article2015 LER Conference at the Bacterial Endotoxin Summit
by Karen Z. McCullough What’s new at this year’s BES? EVERYTHING! Last year our BES highlighted test interference, but our topic for this year is LER, a very specific form
View ArticleA Recent Review Article with a Holistic Perspective of Contamination Control
Scott Sutton, Ph.D. Microbiology Network, Inc. scott.sutton@microbiologynetwork.com A review article on Bioburden Contamination Control was recently published in the American Pharmaceutical Review....
View ArticleHow Pharmacology Helped Standardize Natural Medicine
by Gemma Verma A decade’s long debate has been raging about the safety of complimentary medicines versus the safety of pharmaceutical drugs. With 38% of American adults using alternative
View ArticleBefore and Beyond LER; February 6, 2017 in Dallas, TX
Submitted by LER moderator, Karen McCullough Before and Beyond LER is the theme of this year’s Bacterial Endotoxin Summit sponsored by the PMF. It is the ORIGINAL summit on
View ArticlePMF Fall Forum 2017: Non-Sterile Manufacturing Challenges
Submitted by moderator, Bob Westney This year’s Fall Forum focuses on the challenges we as GMP microbiologists face in the non-sterile manufacturing industries. For many years, regulatory,...
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