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 in relation to the activities of the persons referred to in Article 1(2). All wholesale distribution activities shall be clearly defined and systematically reviewed. All critical steps of wholesale distribution activities and significant changes shall be justified and, where relevant, subject to validation.
2. The quality system shall encompass the organisational structure, procedures, processes and resources, as well as activities necessary to ensure that the veterinary medicinal products delivered maintain their quality and integrity and remain within the legal supply chain during storage or transport.
3. The quality system shall be fully documented. Its effectiveness shall be monitored. All quality-system-related activities shall be defined and documented.
4. A quality manual or equivalent documentation approach shall be established and include a description of any differences in the quality system regarding handling of veterinary medicinal products of different types.
5. A change control system shall be established and incorporate the principles of quality risk management and be proportionate and effective.
6. The quality system shall ensure that the following obligations are fulfilled:
(a)
the procuring, holding, supplying, transport or export of veterinary medicinal products comply with the requirements of good distribution practice for veterinary medicinal products laid down in this Regulation;
(b)
management responsibilities are clearly specified;
(c)
veterinary medicinal products are delivered to the correct consignees 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 veterinary medicinal products are evaluated.
Management of outsourced activities
The quality system shall cover the control and review of any outsourced activities related to the wholesale distribution of veterinary medicinal products. Such control and review shall incorporate quality risk management and shall include:
(a)
assessment of the suitability and competence of the contract acceptor to carry out the activity and checking authorisation status, if required;
(b)
definition of the responsibilities and communication processes for the quality-related activities of the parties involved;
(c)
regular monitoring and review of the performance of the contract acceptor, and the identification and implementation of any required improvements on a regular basis.
Management review and monitoring
1. The management of the persons referred to in Article 1(2) shall establish and implement a formal process for reviewing the quality system on a periodic basis.
2. The review shall include the following:
(a)
a measurement of achievement of the objectives of the quality system;
(b)
an assessment of:
(i)
performance indicators that can be used to monitor the effectiveness of processes within the quality system, such as complaints, deviations, CAPA, changes to processes;
(ii)
feedback on outsourced activities;
(iii)
self-assessment processes including risk assessments and audits; and
(iv)
results of external assessments such as inspections, findings and customer audits;
(c)
emerging regulations, guidance and quality issues that can impact the quality system;
(d)
innovations that might enhance the quality system;
(e)
changes in business environment and objectives.
3. The outcome of each management review of the quality system shall be documented in a timely manner and communicated effectively internally.
Quality risk management
1. The persons referred to in Article 1(2) shall apply quality risk management.
2. Quality risk management shall ensure that the evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the treated animal or animal group, the persons responsible for the animal and the treatment, the consumer of a food producing animal and the environment.
3. The level of detail and documentation of the quality risk management process shall be proportionate to the level of risk to quality.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
