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Know About United State Pharmacopoeia (Usp) by Dr.T.V.Vidyasagar Neuheit Pharma Technologies Private Limited
Know About United State Pharmacopoeia (Usp) by Dr.T.V.Vidyasagar Neuheit Pharma Technologies Private Limited
Know About United State Pharmacopoeia (Usp) by Dr.T.V.Vidyasagar Neuheit Pharma Technologies Private Limited
CONTENTS
Important definitions
Importance of Pharmacopiea
Introduction
History
Sections
Revisions
Other relevant information available related to USP.
Question and Clarifications
Importance of Pharmacopoeia :
Pharmacopoeial
The
All
three statutory components complement and support the quality assurance system
operated by the manufacturer.
Pharmacopoeial
They
apply throughout the shelf-life of a product and are used by a wide variety of
organisations including suppliers, purchasers, inspectors, medicines regulators and
official and independent control laboratories.
USPs standards enforceable in US by FDA- developed & relied upon in >140 countries
USP History
1820
January: Founded by physicians; Only 217 drugs
December 15: First edition was published
1830: First Revision Published; Revisions continue at 10-year intervals
1942: USP revision cycle changed: every 5 years
1975: USP acquired NF and came as USP-NF
2002: USPNF published annually
2006: First international laboratory facility in Hyderabad, India
Certification: ISO 9001:2008: Quality Management Systems standard
ISO 17025:2005 General Requirements for the Competence of Testing & Calibration
Laboratories
USP SECTIONS
All the 3 volumes and 2 supplements become official after 6 months from the release date
Online updation is done with each supplement or annual revision
Volume 1 General notices, chapters, Dietary supplements, Reagents & NF Monographs
Volume 2 USP Monographs A H
Volume 3 USP Monographs I Z
NF contains Excipients monographs. If the excipient is also a drug substance, then it appears
in USP with suitable cross-referencing.
Section
Release Date
Official Date
3 volumes
Nov 1st
Supplement 1
Feb 1st
Aug 1st
Supplement 2
June 1st
Dec 1st
USP-NF Revisions
Annually-standard revisions in USP-NF and twice yearly supplements
Standard revisions:
Published in PF
USP-NF Revisions:
Annually-standard revisions in USP-NF and twice yearly supplements.
Accelerated revisions in PF & on USP Web site (Errata, IRAs & RBs)
Standard revisions: Published in PF
ERRATA :
Text erraneously published in USP-NF or Supplement.
Not subjected to notice or comment.
Published on USP Web site and immediately official.
Incorporated into next USP-NF or Supplement.
INTERIM REVISION ANNOUNCEMENTS:
Given in PF as proposed IRA with 90 day comment period.
If no comments- immediately official on USP Website under Official Text
section.
Incorporated into next available USP-NF or Supplement.
REVISION BULLETIN :
If rapid publication is required.
Posted on 1st of every month in USP website.
Incorporated in next available USP-NF or Supplement.
PHARMACOPEIAL FORUM:
It includes proposed changes and additions to USP-NF.
Also includes stage 4 harmonization and stimuli articles
public comments (90 days)
for