Tag Archive for bioburden

The Compendial Draft Chapter on “Bioburden Control of Nonsterile Drug Substances and Products”

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 Drug Substances and Products” has been released in Pharmacopeial Forum of July/August, 2013.   This chapter describes a risk-based approach to monitor and control of the manufacturing facility and process for non-sterile drugs. Read more

A New Draft Guidance on FDA Expectations for Cosmetic GMP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 only published guidance, until recently, was the Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist (originated February 12, 1997; Updated April 24, 2008).  This guidance situation has recently changed with the release of the draft Guidance for Industry Cosmetic Good Manufacturing Practices (released June 24, 2013).

The draft “Guidance for Industry” released late in June of 2013 is a complete rewrite of the previous guidance document.  This was much needed, as the previous document was in truth a training document for FDA inspectors preparing to audit a cosmetics manufacturer and not a “Guidance to Industry” in any real sense.  Read more