In August, the European Commission Health and Consumers Directorate-General announced changes to Part 1, Chapter 5: Production within Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use.
According to an 11-page document on the subject, the reasons for the change are as follows: “Changes have been made to sections 17 to 21, including adding a new section, to improve the guidance on prevention of cross-contamination and to refer to toxicological assessment. Changes were also introduced in sections 27 to 30, including adding a new section on the qualification of suppliers in order to reflect the legal obligation of manufacturing authorization holders to ensure that active substances are produced in accordance with GMP. The changes include supply chain traceability. Sections 35 and 36 are inserted to clarify and harmonize expectations of manufacturers regarding the testing of starting materials, while section 71 introduces guidance on notification of restrictions in supply.”
Deadline for coming into operation is March 1, 2015.