Veterinary medicines — good manufacturing practice

KEY POINTS

• National authorities must organise regular inspections to ensure manufacturers comply with the principles and guidelines set out in the legislation.
• Manufacturers must:
  • ensure that their activities are properly authorised and respect good manufacturing practice;
  • regularly review their manufacturing methods in the light of scientific and technical progress;
  • establish and implement an effective pharmaceutical quality assurance system, involving management and staff;
  • have enough competent and qualified staff to ensure quality standards are met;
  • define the duties of the managerial and supervisory staff and provide them with appropriate training;
  • establish and maintain documentation records, a quality control system under a suitably qualified person and hygiene programmes;
  • conduct frequent inspections of their operations and take any necessary corrective measures;
  • implement a system to respond to, and investigate, complaints and have measures in place to promptly recall any medicines if necessary, while informing the competent authorities of their action.
• The premises and equipment used must be located, designed, constructed, adapted and maintained to suit their intended purpose, minimise the risk of error and allow effective cleaning and maintenance.
• The quality control system includes access to quality control laboratories and must retain samples of each batch of medicines for at least a year after their expiry date.
• Any work contracted out must be authorised by a written contract setting out the responsibilities of both parties in complying with good manufacturing practice.
• Importers must ensure that the imported products have been manufactured according to standards that are at least equivalent to those in the EU.