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Commission Directive 91/412/EEC of 23 July 1991 laying down… Article 7

Article 7

Personnel 1. At each manufacturing site, the manufacturer shall have competent and appropriately qualified personnel at his disposal in sufficient number to achieve the pharmaceutical quality assurance objectives. 2. The duties of managerial and supervisory staff, including the qualified person(s), responsible for implementing and operating good manufacturing practice shall be defined in job descriptions. Their hierarchical relationships shall be defined in an organizational chart. Organizational charts and job descriptions shall be approved in accordance with the manufacturer's internal procedures. 3. Staff referred to in paragraph 2 shall be given sufficient authority to carry out their responsibilities correctly. 4. Personnel shall receive initial and continuing training including the theory and application of the concept of quality assurance and good manufacturing practice. 5. Hygiene programmes adapted to the activities to be carried out shall be established and observed. These programmes include procedures relating to health, hygiene and clothing of personnel.

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Other provisions in Commission Directive 91/412/EEC of 23 July 1991 laying down…

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 7 of Commission Directive 91/412/EEC of 23 July 1991 laying down… (LawPlayer, data as of 2026-07-04)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

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