WHO Guidelines

WHO Guidelines

World health organization (WHO) provide
the GMP guidelines for pharmaceuticals. These guidelines are followed through
the world.

These guidelines cover all the pharmaceutical topics as:

1. Process validation

2. Cleaning validation

3. Analytical method validation

4. DQ, IQ, OQ, PQ of equipments

5. Water system validation

6. HVAC validation

7. Computer system validation

8. Market complaint handling

9. Product recalls

10 Stability studies and may more...



Following are the general guidelines of WHO.

· General

· Volume 2, 2nd
updated edition













WHO guidelines for Active Pharmaceutical Ingredients

· API  









New TRS





WHO Technical Report Series
961, 2011

44th report

English

WHO
Technical Report Series 957, 2010

43rd report

• English
  
  pdf, 999kb
  
  WHO Technical Report
  Series 953, 2009

42nd report

• English
  
  pdf, 593kb
  
  WHO Technical Report
  Series 948, 2008

41st report

• English
  
  pdf, 1.22Mb
  
  WHO Technical Report
  Series 943, 2007

40th report

WHO
Technical Report Series 937, 2006

• English [pdf 2.08Mb]

39th report

WHO
Technical Report Series 929, 2005

• English [1.21Mb]

38th report

WHO
Technical Report Series 917, 2003

• English [pdf 386kb]

37th report

WHO
Technical Report Series 908, 2003

• English [pdf 632kb]

36th report

WHO
Technical Report Series 902, 2002

• English [pdf 1Mb]

35th report

WHO
Technical Report Series 885, 1999

• English [pdf 7Mb]

34th report

WHO
Technical Report Series 863, 1996

• English
  Part 1 [pdf 3.8Mb] 
• English
  Part 2 [pdf 4Mb]

33rd report

WHO
Technical Report Series 834, 1993

• English [pdf 1.5Mb]

32nd report

WHO
Technical Report Series 823, 1992

• English [pdf 6.4Mb] 

 

· Risk
analysis

· Training
materials

· An
introduction, resource and study pack for trainers

· Blood and
Biological Products

· Radio
Pharmaceuticals

· Further
References









Also Read:

· ISO Guidelines

· US-FDA Guidelines

· ICH Guidelines

· MHRA-UK Guidelines

· MCC Guidelines -South Africa

· TGA Guidelines-Australia

· MCA
Guidelines-Zimbabwe

· Schedule M-India

Validation

Non-sterile
process validation

Cleaning
Validation 

Qualification
of systems and equipment