Standardization

pharmacutical chemistry short explination about standardization and GMP and ISO

1. Pharmacy 5
rd
semester
Pharmaceutical chemistry
By: peshawa Ibrahim
Prof: Malkhas

2. Standardization
Standardization of drug means confirmation of its identity
and determination of its quality and purity and detection of
nature of adulterant by various parameters like
morphological, microscopical, physical, chemical and
biological observations.

Standardization is a numerical value or specific property
that quantifies the purity and quality of drugs and
formulations.

3. THE PROCESS OF DEFINING AND APPLYING The
“CONDITIONS”TO ENSURE THAT A GIVEN RANGE
OF REQUIREMENTS CAN NORMALLY BE MET
WITH A MINIMUM OF VARIETY AND IN
REPRODUCIBLE AND ECOOMIC MANNER ON THE
BASIS OF THE BEST TECHNIQUES
Standardization

4. pharmacopoeia
A pharmacopoeia is a book of standards applicable to
drug substances and their dosage forms used in a
country or region, which accepts it as such. It is
prepared by a recognized authority appointed by the
Government of the concerned country.
The term pharmacopoeia has been derived from the
Greek words pharmakon (drug, remedy) and poeia (to
make, to prepare).

5. De Materia Medica, a five-volume book originally
written in Greek by Pedanius Dioscorides is
considered to be precursor to all modern
pharmacopoeias, and is one of the most influential
herbal books in history.
The monographs in a pharmacopoeia are the treatises
on drugs and formulations which give description,
assay, limits and other details necessary for
maintaining requisite standards.

6. THE MONOGRAPH INCLUDES THE
FOLLOWING FEATURES
1. TITLE – The main title is given in bold capitals. The international
Nonproprietary Name (INN) approved by WHO has been preferred for
the main title. This is followed by synonims.
2. STRUCTURAL FORMULA – This gives the chemical structure of
the molecule.
3. MOLECULAR FORMULA – This gives the different elements
present and numbers of their atoms present in a molecule.

7. 4. MOLECULAR WEIGHT – This is calculated from the molecular formula
using standard atomic weights.
5. DESCRIPTION – Statements on colour, odour, taste and crystalline/ amorphous
nature are given to help in the preliminary evaluation of the integrity of an article.
6. SOLUBILITY – Statements of solubilities are intended to apply at 20 to 30°C.
The terms employed to indicate different degrees of solubility are -
7. Identification – Tests for identification include –
Infrared absorption spectrum
B) Ultraviolet – visible spectra
C) Melting point or boiling point
D) simple chemical tests leading to formation of colour or precipitates.

8. 8. Acidity or alkalinity – For substances which are either acidic or alkaline in
nature, the pH of solution of particular strength is given.
9. Clarity and Colour of Solution – This is also a simple physical test.
10. Limit Tests – These are tests designed to identify and control small quantities
of impurities which are likely to be present in the substance. Comparative method
is used to control the amounts of iron, arsenic, heavy metals, barium, chloride,
sulphate, etc.
11. Loss of Drying – It gives the maximum percentage of loss determined on a
fixed weight of substance dried either in oven at given temperature or over silica
gel, for the specified time.
12. Assay – An assay gives in detail the analitical method for the substance in order
to determine the percentage content of a particular chemical in the given test
sample.
Additional items – Labelling, Uniformity of content, pH, etc.

10. GMP
Good manufacturing practices (GMP) are the practices required in 
order to confirm the guidelines recommended by agencies that control 
authorization and licensing for manufacture and sale of drug products, 
and active pharmaceutical products. These guidelines provide minimum 
requirements that a pharmaceutical product manufacturer must meet to 
assure that the products are of high quality and do not pose any risk to the 
consumer.
Good Manufacturing Practice (GMP) is a set of regulations, codes and 
guidelines for the manufacture of drug substances and drug products, 
medical devices, in vivo and in vitro diagnostic products and foods. 

11. GMP Provides a high level assurance
that:
Medicines are manufactured in a way that ensures their 
safety, efficacy and quality
Medicines are manufactured to comply with their 
marketing authorization

12.  
ISO
The International Organization for Standardization (ISO) is an 
international standard-setting body composed of representatives from 
various national standards organizations.
ISO, the International Organization for Standardization, is 
an independent, non-governmental organization, the 
members of which are the standards organization of the 163 
member countries. It is the world's largest developer of
voluntary international standards and facilitates world 
trade by providing common standards between nations. 
Nearly twenty thousand standards have been set covering 
everything from manufactured products and technology to 
food safety, agriculture and healthcare. 

13. VALIDATION
Process validation is defined as the collection and
evaluation of data, from the process design stage
throughout production, which establishes scientific
evidence that a process is capable of consistently
delivering quality products.
Process validation involves a series of activities
taking place over the lifecycle of the product and
process.

14. THANK YOU
peshawa mangury