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ARGOM Appendix 2: Guidelines on quality aspects of OTC applications

Version 1.1

30 May 2014

Book pagination

Version history

Version Description of change Author Effective date

Update of ARGOM Chapters

  • 4 Quality
  • 4A Manufacture
  • 4B Formulation
  • 4C Starting material specification
  • 4D Finished product specification
  • 4E Stability testing
  • 4F Microbiological testing

Re-formatting of the above chapters as Appendix 2 - Guideline on quality aspects of OTC applications.

MAG - OTCME October 2012
V1.1 Update to 6.6 Colourings in medicines for topical and oral use MAG GSU May 2014

Book pagination