USP Validation Documents

**AnaMariaVR2** · #1 1st June 2012, 11:14 AM

The USP Medicines Compendium has been developed for manufacturers who want to export to countries where regulatory requirements are almost inexistent or without national pharmacopeias.

The USP has now put these new standards online and for free. In doing so, the USP wants to contribute to improve the quality of excipients, APIs and medicinal products worldwide.

The written standards or monographs use a new scientific approach which differentiates itself from the other pharmacopoeias. The particularity of the MC monographs is the "performance-based" approach. The background for this is an article in the Pharmacopoeial Forum Vol. 35(3) from May-June 2009 entitled "Performance-based Monographs".

General Chapters of the USP

**v9991** · #2 1st June 2012, 01:30 PM

You will also find access to many proposed/draft stage mongoraphs-general chapters (including the harmonization chapters) at (btw its free access)

http://www.usppf.com/pf/authenticate

Quote:

The new online-only PF includes proposed revisions and additions to the USP–NF and Stimuli articles for which USP is seeking public comment.

	The Deming PDCA Cycle	ISO 9001 QMS Implementation	FMEA Information	APQP Information
Auditing Information	8-D Problem Solving	Statistics	Error Proofing (Poka Yoke)	Brainstorming
Identifying Waste	Pull Systems	Lead Time Reduction	Planned Maintenance	Quick Setup
Discovering Change	Process Capability - Cp vs. Cpk	Histogram Animation	Process Loop Animation	Taguchi Loss Function
		Fishbone / Cause and Effects Animation