Professional Documents
Culture Documents
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