Study Set Content:
It is a book, pamphlet or document that is
complete in itself or it is a detailed written study
of a single specialized subject or an aspect of it.
monograph
A document that specifies all the tests to be
conducted on a product and/or appropriate
references containing details of procedure and
expected results.
monograph
It is a written document that reflects the quality
attributes of medicines.
monograph
Key Attributes of monograph
identity
strength
purity
performance
Tests to identify that a particular
substance is the medicine that claims to be.
Identity
Information on impurities that may be
present in a medicine and the amount of these
that are permitted.
Purity
Laboratory tests to predict and
demonstrate how a medicine will be released as
it enters the human body.
Performance
USP Monograph
Standard Monograph
ESCOP (The European Scientific Cooperative on Phytotherapy) Monograph
Therapeutic Monograph
WHO Monograph, AHP (American Herbal Pharmacopeia) Monograph.
Combined Monograph
is the “International Conference on
Harmonization of Technical Requirements for
Registration for Pharmaceuticals for Human
Use”
ICH
It is a joint initiative involving both regulators and
research-based industry representatives of the
EU, Japan and the US in scientific and technical
discussions of the testing procedures required to
assess and ensure the safety, quality and
efficacy of medicines
ICH
ICH Members:
● Representatives from the (blank) as well as(blank) and the IFPMA
six co sponsoring
parties
three observers
International Federation of Pharmaceutical
Manufacturers Associations
Japan:
Ministry of Health Welfare and the JPMA
Japan Pharmaceutical Manufacturers
Association
EU (blank) and EFPIA
European Commission , European Federation of Pharmaceutical Industries’
Associations
USA Food Drug Administration and the PhRMA
Pharmaceutical Research and Manufacturers of
America
Observers
WHO, EFTA, and Canada
Q1A - Q1F
STABILITY
Q2
ANALYTICAL VALIDATION
Q3A-Q3D
IMPURITIES
