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Submitted by # Zakir Ullah

Submitted to # Sir Majid Shah

Roll No : PHR 120242048

Assignment # Official Book

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Contents

1) Official Book

2) Introduction

3) United States Pharmacopeia

4) History Of USP

5) British Pharmacopeia

6) History Of British Pharmacopeia

7) Content Of BP

8) Pakistan Pharmacopeia
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Official Book

Pharmacopeia means “ Drug Making “ or “ to make a drug “ this word drives from the ancient
Greek ( Pharmakopoiia ) from ( Pharmako) “ Drug “ followed by the verb stem
( Poi ) make and finally the abstract noun ending ( -ia ).

Pharmacopeia is an official publication describing Drugs, chemical and medicinal

preparations as well as containing direction for compound indentification the word
pharmacopeia is widely used and common spelling but “ Pharmacopeia “ is used only in USP.

United States Pharmacopeia ( USP )

Introduction and background :

The united states pharmacopeia USP has been an independ standards – setting organization
serving public health needs since it was founded in 1820, over the two centuries that followed
USP envolved to meet the changing priorities of public health while adapting to scientific and
teachnological inovations and
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Advances in healthcare. Today USP and other robust pharmacopeias provide a multitude of
scientifically rigorous, publicily available standard that secured public trust in the quality of
medicines and medical products. Usp developes qualitiy standards through independent
committiees of scientific experts who work with regulators, industry partners and other
stakeholders to establish documentary standards, ( general chapters and monographs ) and
physical refrence standards ( vials of pure drug ingredients ) taken together documentary and
physical standards articulate the quality expectations for medicine along with analytical
methods and physical specimens to help ensure that a product meets quality expectations,
USP also work closely with other national pharmacopeias for global pharmacopeial
coordination efforts, USP.s Unbaised Science-Based approach to standards-setting is one of
the key reasons USP is viewed as one of the most credible sources of public quality standard
for medicines.
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History Of USP
1) The birth of a standard : The united states pharmacobia emerged in response to a pressing
need for standardized and reliable medicines.
2) 1820 : A group of ii physicians convened in washington D.C, to address this issue, Their
efforts culminated in the creatrion of the first united states pharmacobia.
3) 1906 : The pure food and act recognized the USP and the national formulary ( NF ) as
official standards for drug quality.
4) 1938 : The federel food drug, and cosmetic act reinforced the importance of the USP and
(NF).
5) 1975 : The USP acquired the NF merging the two essential compendia into a single
authoritative source role and function of a pharmacobeia.
Safe and effective medicines, consistently manufactured according to established quality
standards, are essential to preventing diseas teating illness, and saving lives.;
Understanding drug standards monograph
structure.
Title : The official name of the drug.
Definition : A clear and concise description of the drug.
Identification : Tests to confirm the identity of the drug.
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British Pharmacopeia
Headquaters : London United Kingdom.
The most comprehensive collection of authoritative official standards for UK
pharmaceutical substances and medical products. Which is used by individuals and
organization involved in pharmaceutical research, development, manufacture and testing.
The british pharmacopeia is an important statutary components in the control of medicines,
Which complements and assists the licensing and inspection processes of the UK’s medicines
and healthcare product regulatory agency. ( MHRA).
Legal Basis
The british pharmacopeia is published on behalf of the health ministers of the united kingdom.
On the recommendation of the commision on human medicines in accordance with section 99
(6) of the medicines act 1968, and notified in draft to european commision (EC) in accordance
with directive 98/34 IEEC.
The monographs of the european pharmocopoia in the pharmocopoia certain drugs.
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History
The regulation of medicinal products of official in the United Kingdom dates back to the reign
of king Henry VIII (1491-1547). The royal college of physicans of london had the power to
inspect apothecaries, Products in the london area and to destroy defective stock.
The first list of approved drugs, with information was the london pharmacopeia, Published in
1618 the first edition of what is now known British pharmacopeia was published in 1864.
In 1844, concern about the dangers of unregulated manufacture and use lead William
Flockhart – The medicines act 1968 established the legal status of the British Pharmacopeia
commision.
Content :
The current edition of the British Pharmacopeia comprises six volumes , Which contain 3,000
monographs for drug substances, and reference spectra, used in the practice of medicine, all
comprehensively indexed and cross-referenced for easy reference. Items used exclosively in
veternary medicine in the UK are included in BP ( veternary ) .
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Volumes I and II
Medical Substances
Volume III
 Formulated preparations
 Blood relative preparations
 Immunological products
 Radiopharmaceutical preparations
 Surgical materials
 Homeopathic preparations
Volume IV
 Appendices
 Infrared reference SP
 Index
Volume V
 British pharmacopeia ( veternary )
Volume VI ( CD-ROM version )
 British pharmacopeia
 British pharmacopeia (veternary )
 British approved names
The british pharmacopeia is available as a printed volume and electronically in both on lines
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Pakistan pharmacopeia
Pakistan pharmacopeia by ministry of health pakistan.
The government of pakistan constituted pakistan pharmaceutical commite in 1964 for
preparation of pakistan pharmacopeia it’s first edition was published in 1973 by ministry of
health.
It contain monograph of NO, of drugs.
What is monograph.
“ A monograph is collection of detailed information on a particular drug, it dosage form and
methods of analysis some feature of pakistan pharmacopeia.
1) Standards for pharmaceutical substances and medicines.
2)Monographs for individuals medicines.
3)General chapter on pharmaceutical terminology, dosage form and pharmaceutical
calculations.
4) Guidance on good manufacturing practices (GMP) and good laboratory practices (GLP).
5) Regular updates to reflect changes in pharmaceutical science, teachnology and regulations.
and CD-ROM versions.