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...]
FIND FDA WARNING LETTERS AND RECALLS THAT DISCUSS THE LATEST REGULATORY THOUGHTS
USE “KEY WORDS’ THAT PROVIDE FOCUSED SEARCHES Barry A Friedman, PhD has been publishing a variety of Regulatory Actions including information regarding Warning Letters, Recalls, and other regulatory activities for over three years. These 140+ Regulatory Actions often include FDA related activities that are not readily found within the FDA … [Read more...]
NEW DRUG MICROBIOLOGY STAFF MEMBER PRESENTS INFORMATION ON ON-GOING PILOT PROGRAM
PROGRAM INCLUDES THE REVIEW OF NON-STERILE PRODUCTS John W. Metcalfe, Ph.D., of the New Drug Microbiology Staff at CDER gave an excellent, informative presentation on “Regulatory Review Perspectives for Non-Sterile Drug Products” at the PDA Global Microbiology Conference on Monday, October 21, 2013 in Bethesda, MD. This presentation presented information on a Pilot Program … [Read more...]
BIOBURDEN CONTROL OF NONSTERILE DRUG SUBSTANCES AND PRODUCTS (USP)
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...]
FDA’s GUIDANCE FOR INDUSTRY PROVIDES CIRCUMSTANCES THAT CONSTITUTE DELAYING, DENYING, LIMITING OR REFUSING A DRUG INSPECTION
LEARN OF FDA's CURRENT THINKING REGARDING AUDITING ISSUES The FDA recently released a new DRAFT Guidance for Industry on July 12, 2013 that is entitled "Circumstances that Constitute Delaying, Denying, Limiting or Refusing a Drug Inspection". The Draft Guidance for Industry uses examples that illustrate the most common situations that the FDA has encountered and provides very … [Read more...]
