EudraLex – Volume 4 GMP – Chapter 1 – Pharmaceutical Quality System – revision 3 and Chapter 7 – Outsourced Activities

EMA published revision 3 of GMP Chapter 1 and renamed it to “Pharmaceutical Quality Systems”, as refered to ICH Q10, and Chapter 7 “Outsourced Activities”.

The deadline for coming into operation of both chapters is 31 January 2013.

Contact us today for more information or on how to integrate PQS and QRM at:

Further reading: Current interpretation of Chapter 7 to Annex 11 requirements – Read it online