Quality Management System

A quality system is required to ensure that the objectives of good distribution practice are realised and should clearly set out responsibilities, processes and risk management principles in relation to the wholesale dealers’ activities.

2.1 Development and maintenance of a quality system

  1. The quality system is the responsibility of the organisation’s management, which requires their leadership and active participation. There must be a suitable quality management system in place, which takes into account the size, structure and complexity of the wholesale activities.
  2. The quality system must ensure that the identity of the medicinal product is not lost, that the wholesale distribution of veterinary medicinal products is performed according to the information on the product’s packaging or summary of product characteristics (SPC) and that there is full traceability. The system must also minimise the risk of counterfeit veterinary medicinal products entering the legal supply chain.
  3. The quality system must be adequately resourced with competent personnel, and with suitable and sufficient premises, equipment and facilities.

2.2 Requirements for the quality system

  1. The quality system must be fully documented, signed off by the person responsible and have version control. The effectiveness of the quality system must be monitored.

  2. The quality system must ensure that:

    • (i) management responsibilities are clearly defined
    • (ii) veterinary medicinal products are procured, held, supplied, transported or exported in a way that is compliant with the requirements of GDP
    • (iii) products are delivered to the correct recipients within an acceptable time period and in storage conditions required by a product’s SPC
    • (iv) records are made contemporaneously
    • (v) deviations from established procedures are documented and investigated
    • (vi) appropriate corrective and preventive actions (CAPA) are taken to correct deviations in line with quality risk management procedures
    • (vii) any changes which may affect the storage or distribution of veterinary medicinal products are assessed in line with quality risk management procedures.
  3. The quality system must set out the responsibilities, processes and control measures to reduce the risks associated with the distribution activities. Written procedures must describe the different operations that may affect the quality of the products or of the distribution activity and include details of the recording system to be used. The quality system must be reviewed at appropriate intervals (at least annually) and must be the responsibility of the organisation’s management.

2.3 Management of Outsourced Activities

  1. Any activity relating to the distribution of veterinary medicinal products that is outsourced must be correctly defined, agreed and controlled to ensure the integrity of the product. The quality system must cover contract management and review. Quality risk management must be considered.

  2. There must be a written contract between the contract giver and the contract acceptor which clearly states where the division of responsibilities lie, and the standards expected to maintain the safety, quality and efficacy of the veterinary medicinal products involved. This is usually called a ‘Technical Agreement’ and is signed by both parties. The agreement must also include:

    • (i) the scope of the agreement, including the product range and processes required
    • (ii) a clear definition of the responsibilities for both parties for the quality-related activities involved
    • (iii) regular monitoring and review of the performance of the contract acceptor, and the identification and implementation of any required improvements on a regular basis
    • (iv) systems to ensure regular communication and review of the contracted processes and activities.

2.4 Management Review and Monitoring

  1. There must be a defined process in place for a periodic management review of the quality system, and this must occur at least annually. This review should include assessments of:

    • (i) Deviations to the quality system, including CAPA investigations and any resulting changes made to the business, including changes to the site/buildings or the wholesale process.
    • (ii) Results from any audits, both internal and external or regulatory.

  2. This management review must be documented and retained for inspection.

2.5 Quality Risk Management

  1. Risk management must be applied to the quality management system to ensure that any risk to the quality, safety or efficacy of the veterinary medicinal product is minimised. The evaluation of risk must consider the full supply chain, including the treated animal, the persons responsible for the animal and for giving the treatment, the environment, and for food producing animals, the consumer of the produce.