S.L. 458.42 Art. 8Personnel.

It shall be the duty of the manufacturer to ensure that:

(a) there is at each manufacturing or import site, a sufficient number of competent and appropriately qualified personnel at his disposal to achieve the pharmaceutical quality assurance objective;

(b) the duties of the managerial and supervisory staff, including the qualified persons, responsible for implementing and operating good manufacturing practice, are defined in the job descriptions;

(c) the hierarchical relationships of the manufacturer’s staff are defined in an organisation chart;

(d) the organisation charts and job descriptions are approved in accordance with the manufacturer’s internal procedures;

(e) the staff have sufficient authority to discharge their responsibility correctly;

(f) the personnel receives initial and ongoing training, the effectiveness of which shall be verified, covering in particular the theory and application of the concept of quality assurance and good manufacturing practice,;

(g) the hygiene programmes adapted to the activities to be carried out shall be established and observed and such programmes shall, in particular include procedures relating to health, hygiene practice and clothing of personnel.