The EC has published several revised chapters of the EU guidelines for GMP in August, minor changes were made in chapters 3 (Premises and Equipment) and 5 (Production). Chapter 8 (Complaints, Quality Defects and Product Recalls) has been completely revised and is extended from two pages to six. Chapter 6, which was published in March has come in operation on October 1st.
|Chapter||Published||Deadline for coming into operation|
|3: Premise and Equipment||13 August 2014||1 March 2015|
|5: Production||13 August 2014||1 March 2015|
|6: Quality Control||28 March 2014||1 October 2014|
|8: Complaints, Quality Defects and Product Recalls||13 August 2014||1 March 2015|
|Annex 15: Qualification and validation||Under revision|
|Annex 16: Certification by a QP and Batch Release||Under revision|
The changes in both chapters 3 and 5 are based on a specified guidance on the prevention of cross-contaminations. Chapter 3 defines the moment at which a dedicated facility or equipment is required. Chapter 5 focuses on quality risk management (QRM) and possible measures that will results from the QRM. This chapter has also been extended to include 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.
Major changes have been made to chapter 8, defining guidelines for personnel and organization, procedures for handling and investigating complaints, quality defects, root cause analysis and corrective and preventive actions (CAPA).
The deadline for coming into operation is set on March 1st 2015. For more details see the final guidelines on eudralex: http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm