Development and maintenance of a quality system
1. The persons referred to in Article 1(2) shall develop and maintain a quality system.
2. The quality system shall take into account the size, structure and complexity of the activities of those persons and the changes foreseen for those activities.
3. The persons referred to in Article 1(2) shall ensure that all parts of the quality system are adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities.
Requirements for the quality system
1. The quality system shall set out responsibilities, processes and quality risk management principles.
2. It shall ensure that the following obligations are fulfilled:
(a)
the procuring, import, holding, supplying, transport or export of active substances used as starting materials in veterinary medicinal products comply with the requirements of good distribution practice for active substances used as starting materials in veterinary medicinal products laid down in this Regulation;
(b)
management responsibilities are clearly specified;
(c)
active substances used as starting materials in veterinary medicinal products are delivered under the right conditions, to the correct consignees and within an appropriate time period;
(d)
records are made contemporaneously;
(e)
deviations are documented and investigated;
(f)
appropriate corrective and preventive actions (‘CAPA’) are taken in line with the principles of quality risk management;
(g)
changes that may affect the storage and distribution of active substances used as starting materials in veterinary medicinal products are evaluated.
