Article 5–Article 8 · 4 articles
Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Persons responsible for the quality system
1. The persons referred to in Article 1(2) shall designate a natural person as a person to be responsible for the quality system at each location where distribution activities are performed.
2. The persons responsible for the quality system shall have defined authority and responsibility for ensuring that a quality system is implemented and maintained as well as be personally responsible for fulfilling their obligations.
3. The persons responsible for the quality system may delegate their tasks but not their responsibilities.
Personnel involved in the distribution of active substances used as starting materials in veterinary medicinal products
1. The responsibilities of all personnel involved in the distribution of active substances used as starting materials in veterinary medicinal products shall be specified in writing.
2. Personnel shall be trained on the requirements of good distribution practice for active substances used as starting materials in veterinary medicinal products laid down in this Regulation. Furthermore, personnel shall have the appropriate competence and experience to ensure that active substances used as starting materials in veterinary medicinal products are properly handled, stored and distributed.
Training of personnel
1. Personnel shall receive initial and continuing training relevant to their role, based on procedures and in accordance with a written training programme.
2. The persons referred to in Article 1(2) shall keep a record of all training and periodically assess and document its effectiveness.
Hygiene
The persons referred to in Article 1(2) shall establish appropriate procedures relating to personnel hygiene, including personal health and appropriate clothing, relevant to the activities carried out. Personnel shall comply with those procedures.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
