Brussels releases advice on good distribution practice

Published: 18-Apr-2014
Regulatory

Clarifies practical issues such as how to define personnel as competent


The European Commission has moved to clear up potential confusion over new European Union (EU) guidelines released in last November on good distribution practice for medicines.

In a question and answer document, Brussels clarified practical issues such as how a company should define personnel as competent. The answer: 'Having the necessary experience and/or training to adequately perform the job'.

The Commission shied away from saying how often ‘periodic assessment’ of staff should take place, saying it was 'flexible' on the issue, although companies should follow national laws.

The Commission is similarly relaxed about how companies should protect medicines from adverse weather conditions: 'Any tool…is acceptable.'

Meanwhile personal hygiene requirements 'only refers to the cleanliness of the staff, so to avoid any alteration of the product,' it said.

The Commission stressed that equipment must have a CE marking, but only for plant dating from 1993 or later. And it said that 'all deviations from established procedures should be documented.'

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