Introduction-
Pharmacopoeia-
The word derives
from the ancient “Greek word” Pharmakopoiia.
Pharmako =
drug , poi = make , ia
These
three elements are read as “ drug- mak- ing” or to make a drug.
Pharmacopoeia
is a legally official book binding which are issued by recognized authorities
appointed by Government of each country.
It
comprises list of pharmaceutical substance, direction for identification of
compound Collection, formula along with description prepared by national
authority of standard and quality specifications for medicines used in the
country.
A quality
specification is composed of appropriate tests that will confirm the identity
and purity of the product, Detect the amount of active substance and its
performance
The text
cover pharmaceutical is starting materials exception intermediates and finished
pharmaceutical product (FPPs) general requirements may also given in
pharmacopoeia on important subject related to medicines quality, such as
analytical methods, microbiological purity etc.
The role
of modern pharmacopoeia is to furnish (give) quality specification for active
pharmaceutical ingredient APIs. Finished pharmaceutical product and general
requirement example- for doses form
specification and requirement for proper functioning or regulatory control of
medicines.
The International Pharmacopoeia (Ph. Int.) is issued by WHO
as a recommendation with the aim to provide international standards – including
less technically demanding alternatives where needed - for adoption by Member
States and to help achieve global uniformity of quality specifications for
selected pharmaceutical products, excipients and dosage forms.
History-
The term of Pharmacopoeia first (take) as a separate title
in published in Basel, Switzerland in 1561 by Dr A. Foes, but does not appear
to have come into general use until the beginning of the 17th century.
Today’s pharmacopoeias focus mainly on assurance of quality
of products by various tools of analytical sciences
The aim to achieve a wide global harmonization (link- up) of
quality specifications for selected pharmaceutical products, excipients and
dosage forms came with increased globalization and reciprocal (mutual)
collaboration.
History
of these approaches goes back to 1902–1925 when agreements established a
″Unified″ Pharmacopoeia.
In 1929 the
"Brussels Agreement" fixed the League (union) of Nations to carry out
related administrative functions.
Eight years later, in 1937, the first meeting of the
″Technical Commission of Pharmaceutical Experts″ was held.
An important date in the history of quality assurance of
medicines is 1948, when the First World Health Assembly (WHA) approved the
Expert Committee on Unification of Pharmacopoeias to continue this work.
Important
Definition-
Monograph- A document that describes drug standard and provide detailed
information about determine medicine,
key quality and can be mark legal medicine quality in any country.
Appendix/ supplement- That provides
additional details or information or data on topic like interaction, borderline substances (cosmetics,
food supplements, medical devices), cautionary
labels (warning labels) etc, which support the content of main document.
Addendum- A book published by the Indian Pharmacopoeia
Commission (IPC) for standards of drugs manufactured
and marketed in India. They
also include to revised or new monographs and
general chapters covering in various areas,
example- Pharmaceuticals, veterinary biological products, and phyto-pharmaceutical
etc.
Amendment- To changes
the information in a pharmacopoeia, like as- changes in API preparation
and/or control. They can also include in additional information,
reanalysis of data, clarifying, modifying an application or procedure.
INDIAN
PHARMACOPOEIA:-
§ First official IP was appeared (come into view) in
1868 which was edited (accomplished) by Edward John Waring
§ Before independence days, British
Pharmacopoeia (BP) was used in India.
§ The addendum of BP in 1898 was published in 1900 and
accepted by Government of India edition in 1901
§ In 1946 Government of India issued one list known as
‘The Indian Pharmacopoeial list’
§ “The Indian Pharmacopoeial list” are prepared by Committee
under chairmanship of Sir R. N. Chopra along with other 9 member.
§ It was prepared by Department of
Health, Govt. of India, Delhi in 1946.
§ In 1948 Government of India
appointed an IP committee for preparing „Pharmacopeia of India‟
§ Tenure (Awadhi) of this committee was 05 years.
§ Indian Pharmacopeia committee under chairmanship of
Dr. B. N. Ghosh Published first edition of IP in 1955
§ First edition of IP is written in English &
official titles of monographs given in Latin.
BRITISH PHARMACOPOEIA:-
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