The changes are designed to incorporate the quality principles described in ICH Q10
The deadline for the new review of chapter 2 of part of the European Good Manufacturing Practices Guide (EU GMP) relating to personnel to come into force is 16 February. The changes need to incorporate the principles of the “pharmaceutical quality system” as described in ICH Q10. “There must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer”, explains the “Principle” paragraph of chapter 2. “Individual responsibilities should be clearly understood by the individuals and recorded. All personnel should be aware of the principles of Good Manufacturing Practice that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs.” A section about consultants has been added, complementing the sections relating to key personnel, training, and personnel hygiene.