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Can a person apply for QP eligibility if he/she only has experience in a bulk manufacture or research and development environment?

April 26, 2017bulk Development eligibility Environment experience manufacture person QP Research

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Can a person apply for QP eligibility if he/she only has experience in a bulk manufacture or research and development environment?

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Under Article 49 of Directive 2001/83/EC, the relevant practical experience has to be gained in a facility that holds a full manufacturer’s licence. As most API (bulk drug) and R & D do not currently (and typically) require a manufacturer’s licence, they cannot be used as areas of relevant experience to satisfy the practical experience requirements.