Update of EMA GMP website – 22. August 2013

Today the EMA has done a major website update of the EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines:

  • New Chapter 2: Personnel  – coming into operation: 16 February 2014
  • Draft Versions of Chapter 3 Premises and Equipment, Chapter 5 Production, Chapter 6 Quality Control, and Chapter 8 Complaints and Product Recall (public consultation closed)
  • Part III: Template of the “written confirmation”
  • Revised version of Annex 16 – commenting phase until 5. November 2013
  • Section: Other documents related to GMP – revised version of the Guidelines on Good Distribution Practice of Medicinal Products for Human Usepdf  (2013/C 68/01)

Check out the updated website of the EMA.