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 Use
(2013/C 68/01)