ICH guidelines technical requirements for pharmaceuticals for human use

2.  The international council for harmonization of technical requirement
for pharmaceuticals for human use [ICH] was created in 1990 and
brings together regulatory and pharmaceutical industry authorities to
discuss scientific and technical aspect of drugs development
&registration.
 The ICH secretariat is based in Geneva.
 The biennial meetings and conference of the ich steering committee
rotate between the EU ,Japan,and the USA .

3.  To increase international harmonization of technical requirements to
ensure that safe ,effective and high quality medicines are developed
 To develop and register pharmaceuticals in the most efficient and
cost effective manner.
 Promote public health
 To prevent unnecessary duplication of clinical trails
 To minimize the use of animal testing without compromising safety
and effectiveness of drug.

4. MEMBER OF ICH
 ICH is splits into representatives from 6 parties represent the regulatory bodies and
research –based industry in European union, Japan and Japan and the USA.
 Japan ,Members are the ministry of health ,labour and welfare [MHLW],Japan
pharmaceutical industries and associations{JPMA}
 In Europe the members are the European union [EU], and the federation of
pharmaceutical industries and associations .
 In the USA the members are the food drug administration [FDA],pharmaceutical
research and manufacturing of America [PHRMA].
 Additional members include observer from the world health organization.
 European free trade association and Canada.

5.  QUALITY
 EFFICACY
 SAFETY
 MULTIDISCIPLINARY

6. ZONE 1:tempreture
ZONE 2:subtropical with possible high humidity
ZONE 3: hot /days
ZONE4:hot /humid

7. Q1-Q1F: Stability testing
Q2: Analytical validation
Q3A-Q3B: Impurities
Q4A-Q4B: Pharmacopeias
Q5A-Q5E: Biotechnological products
Q6A-Q6B: test procedure acceptance criteria
Q7: GMP
Q8:pharmaceutical development
Q9: Quality risk management
Q 10: pharmaceutical quality system