23/24 September 2021
The European Commission has published the revised Chapter 2 on Personnel, which will come into operation on 16 February 2014. Changes have been made in order to integrate the principles of "Pharmaceutical Quality System" as described in the ICH Q10 guideline.
The basic principles of the chapter have been unchanged; however a few new approaches have been added.
More important role of Senior Management:
The role of senior management for the quality management system has been emphasised. Senior management now has the "ultimate responsibility to ensure an effective quality management system is in place to achieve the quality objectives". Senior management should also "establish a quality policy that describes the overall intentions and direction of the company related to quality". They should also participate in the management review.
Additionally, senior management has the responsibility to "maintain the quality management system and continually improve its effectiveness" and to provide all resources needed.
Introduction of a Head of Quality Assurance
The new chapter accommodates the trend in pharmaceutical industry to move more and more quality related tasks to a quality assurance department. In the current version, which will now be replaced, a lot of quality related responsibilities were assigned only to the Head of Quality Control and the Head of Production. Now, additionally and depending on the size and organisational structure of a company, a "separate Head of Quality Assurance or Head of the Quality Unit may be appointed". In this case, some of the responsibilities can be shared with the Head of Quality Control and Head of Production.
A section has been added on consultants
According to the new paragraph 2.23, consultants "should have adequate education, training, and experience". And their qualifications need to be documented.
For ECA members, we have created a document comparison contrasting the requirements of the current 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.
Additonal information can also be found in the new "Chapter 2: Personnel".