|
The recently published new Chapter 1 of the EU-GMP Guide now also includes concepts and principles described in the ICH Q10 guideline on Pharmaceutical Quality System. Some of the changes are very comprehensive. This already becomes clear from the title which was changed from "Quality Management" to "Pharma Quality System". This new term can be found constantly in the document. One approach now introduced in the EU-GMP Guide is continuous and continual improvement. It is one important part for allowing "consistent delivery of products with appropriate quality attributes" whereas Continual Improvement is "facilitated through the implementation of quality improvements appropriate to the current level of process and product knowledge". Besides the Product Quality Review (PQR, now described in part 1.10), a Management Review becomes necessary to "identify opportunities for continual improvement of products, processes and the system itself". This review should involve senior management as well. When extended to pharmaceutical development lifecycle stages as described in ICH Q10, the Pharmaceutical Quality System "should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities". ICH Q10 on Pharmaceutical Quality System is still reproduced in Part III of the EU-GMP Guide and contains a dedicated chapter on "Continual improvement of process performance and product quality" and another one on "Continual improvement of the pharmaceutical quality system". Continual improvement is one of the main goals of the whole document. It advises to identify "sources of variation affecting process performance and product quality for potential continual improvement activities". CAPA could then be used as an effective system for continual improvement. For ECA members, we have created a document comparison contrasting the requirements of the old version of Chapter 1 with the new requirements. In this document, you can see exactly where changes and deletions have been made. The document comparison can be found in the ECA Members Area. To find more details please see the the new Chapter 1 of the EU-GMP Guide. The deadline for coming into operation is 31 January 2013! |
|
|
