This documents sets out frequently-asked ‘questions and answers’ regarding the new guidelines on Good Distribution Practice of medicinal products for human applicable as of 8 September 2013, and their revision of November 2013.

1. QUESTION:IN CHAPTER 2 – PERSONNEL, 2.3.(1), WHAT IS THE DEFINITION OF « COMPETENT »?
Answer: Having the necessary experience and/or training to adequately perform the job.

2. QUESTION: CONCERNING CHAPTER 2 – PERSONNEL, 2.4.(1), IS IT POSSIBLE TO EMPLOY STAFF STARTING THEIR PROFESSIONAL CAREER?
Answer: Yes, if you properly training them before assigning them to their tasks.

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