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Commission Delegated Regulation (EU) 2017/1569Show full title
Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (Text with EEA relevance)
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Changes over time for: Article 6
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Article 6U.K.Personnel
1.At each manufacturing site, the manufacturer shall have a sufficient number of competent and appropriately qualified personnel at his disposal to ensure that the investigational medicinal products are of the quality required for their intended use.
2.The duties of managerial and supervisory staff, including the qualified persons, responsible for implementing and operating good manufacturing practice shall be set out in their job descriptions. Their hierarchical relationships shall be set out in an organisation chart. The organisation chart and the job descriptions shall be approved in accordance with the manufacturer's internal procedures.
3.The staff referred to in paragraph 2 shall be given sufficient authority to discharge their responsibility correctly.
4.The personnel shall receive initial and ongoing training covering in particular the following areas:
(a)the theory and application of the concept of pharmaceutical quality;
(b)good manufacturing practice.
The manufacturer shall verify the effectiveness of the training.
5.The manufacturer shall establish hygiene programmes, including procedures relating to health, hygiene practice and clothing of personnel. The programmes shall be adapted to the manufacturing operations to be carried out. The manufacturer shall ensure that the programmes are observed.
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