European Commission: Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Chapter 5: Production.

Reasons for changes: changes have been proposed to sections 25 and 26 on the qualification of suppliers of starting material in order to reflect the legal obligation of manufacturing authorisation holders to ensure that active substances are produced in accordance with GMP. Supply chain traceability for starting materials is also introduced in sections 26 and 27. A new section, 31, is proposed in order to clarify and harmonise expectations of manufacturers regarding the testing of starting materials. Further work on chapter 5 is ongoing, affecting section 19, as referred to in the Concept Papers published by EMA in February 2005. EMA also published progress reports on this work in February 2008 and December 2009.