World Health Organisation (WHO) plans to revise its current good manufacturing practices (GMP) for active pharmaceutical ingredients (APIs)
PROPOSAL FOR REVISION:
WHO GOOD MANUFACTURING PRACTICE (GMP) FOR ACTIVE PHARMACEUTICAL INGREDIENTS (APIs)
Discussions were held at an informal WHO consultation on new approaches and risk evaluation for manufacturer of medicines in Geneva on 30 May -1 June 2007 as to whether the current WHO good manufacturing practices (GMP) for active pharmaceutical ingredients (APIs) should be revised to bring them into line with the ICH GMP guide for APIs (reference ICH Q7A).
Both texts can be found at the following web links:
- WHO good manufacturing practices (GMP) for active pharmaceutical ingredients (APIs). In: WHO good manufacturing practices: starting material. In: Quality Assurance of Pharmaceuticals. A compendium of guidelines and related materials, Volume 2, 2nd updated edition. Geneva, World Health Organization, 2007, p.188: http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
- ICH GMP guide for APIs (ICH Q7A): http://www.ich.org/cache/compo/276-254-1.html)
In this respect a stepwise approach should be considered, including different scenarios.
It was recommended that the ICH Q7A guide should be adopted because:
– it has been adopted by numerous regulatory authorities worldwide ;
– use of the guide has shown it has been well written ;and
– Many API manufacturers already comply with ICH guidelines.
The World Health Organization develops global guidelines, for which it must work through its own processes with confirmation by the WHO Legal Counsel.
During the above–mentioned consultation various approaches used in different countries were presented, e.g.
- Brazil: implements ICH Q7A, first listing of manufacturers followed by inspection;
- China : licensing of API manufacturers , revision of GMP is under way , and selected items of ICH Q7A will be adopted for the parts not included in the main GMP text Finalization is expected end 2007;
- India: APIs mostly produce for experts, and compliance with Schedule M (since 2005), with no change for API GMP requirement.
- Replace the current WHO GMP guide for APIs by the principles of ICH Q7A.
- If the new approach as in 1 .above is adopted a stepwise approach towards new GMP condition is proposed.
The implementation phase might take time and a transition phase would be necessary.