Study Set Content:
MHRA
(Medicines and Healthcare products
Regulatory Agency)
ASTM
(American Society of Testing and
Materials)
EPA
(Environmental Protection Agency)
TGA
(Therapeutic Goods Administration)
UKAS
(United Kingdom Accreditation Services)
Regulatory Authorities
● WHO
● FDA
● ICH
● MHRA
● TGA
Standard Institutions
● ISO
● ASTM
● EPA
● UKAS
A document containing the result of all the tests
conducted on a specific material or product to
show compliance or non-compliance with
established standards or specifications
approved by responsible personnel.
Certificate of Analysis
Pharmakon
(Drug)
Poeia
To make
Pharmakon (Drug) + Poeia(To make) =
Pharmacopeia
A legally binding collection, prepared by a
national or regional authority & contains a list of
medicinal substances, crude drug & formulation
for making preparation from them.
Pharmacopeia
It comprises list of pharmaceutical substances,
formulae along with their description and
standards
Pharmacopeia
Types of Pharmacopoeia
1. British Pharmacopeia
2. United State Pharmacopeia
3. European Pharmacopoeia
4. Indian Pharmacopoeia
National Pharmacopoeia of the United
Kingdom
British Pharmacopeia
An important statutory component in the
control of medicines. Along with the
British National Formulary (BNF), it
defines the UK’s Pharmaceutical
Standards.
British Pharmacopeia
1st USP was in
1820
Pharmacopeia that aims to provide
common quality standards throughout
Europe to control the quality of
medicines and the substances used to
manufacture them.
European Pharmacopoeia
1st Indian Pharmacopoeia was in
1955
an autonomous institution of the
Ministry of Health and Family Welfare
which sets standards for all drugs that
are manufactured, sold, and consumed
in India.
Indian Pharmacopoeia Commission
(IPC)
