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Good manufacturing practice for veterinary medicinal products

This Directive lays down the principles and guidelines of good manufacturing practice for veterinary medicinal products. These principles and guidelines primarily concern personnel, premises and equipment, production, documentation, quality control, contracting out, and inspections, complaints and product recall. The Member States must ensure that manufacturers respect these principles and guidelines.

ACT

Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products.

SUMMARY

Veterinary medicinal products manufactured or imported into the Community, including those intended for export, must be manufactured in accordance with the principles and guidelines of good manufacturing practice *.

The principles and guidelines primarily concern personnel, premises and equipment, production, documentation, quality control, contracting out, and inspections, complaints and product recall.

Quality assurance system: personnel, premises and equipment

Manufacturers * must set up an effective pharmaceutical quality assurance system *, involving the management and personnel of the various services concerned.

At each manufacturing site, the manufacturer must have persons responsible for implementing the good manufacturing practice, who have the expertise required to achieve the objective of pharmaceutical quality assurance.

Personnel must receive regular training, covering the theoretical and practical aspects of quality assurance and good manufacturing practice.

Hygiene programmes adapted to the activities must be established, including procedures relating to health, hygiene and clothing of personnel.

Premises and equipment must also be subject to strict hygiene standards in order to prevent contamination and any adverse effect on the quality of products. Moreover, premises and equipment to be used for manufacturing operations which are critical for the quality of the products must be checked for suitability.

Production

Production must be carried out in accordance with good manufacturing practice and must follow the pre-established instructions and procedures.

Technical or organisational measures must be taken in order to avoid, in particular, cross-contamination.

New manufacturing processes and those that have been substantially changed must be validated, while critical phases of the manufacturing process must be regularly revalidated.

Documentation

Manufacturers must use a system of documentation covering the various manufacturing operations performed. These documents trace the history of the manufacture of each batch.

Electronic or other data processing systems may replace written documents. In this case, the manufacturer must prove that the data will be appropriately stored during the period in question.

Quality control

Manufacturers must have a quality control department at their disposal. This department must be placed under the authority of a person independent of the other departments and having the required qualifications. It must have at its disposal one or more quality control laboratories appropriately staffed and equipped to carry out the necessary testing of the raw materials and packaging materials and the intermediate and finished products. Resorting to outside laboratories may be authorised.

During the final control of finished products before their release for sale or distribution, the quality control department must take into account, in particular, production conditions, results of in-process controls, the examination of the manufacturing documents and the conformity of products with their specifications.

Samples of each batch of finished products must be retained for at least one year after the expiry date. In addition, samples of certain raw materials must be retained for at least two years after the release of the product. This period may be shortened in certain cases.

Work contracted out

Any manufacturing operation must be the subject of a written contract between the contract giver and the contract acceptor. This contract must set out the responsibilities of each party. The contract acceptor must respect the principles and guidelines of good manufacturing practice and must submit to inspections carried out by the competent authorities.

Inspections, complaints and product recall

Member States must set up regular inspections in order to ensure that manufacturers respect the principles and guidelines of good manufacturing practice laid down by this Directive.

Manufacturers must ensure that the manufacture of medicinal products complies with good manufacturing practice and with the manufacturing authorisation. Regular self-inspections must be conducted in order to monitor the respect of good manufacturing practice and, if necessary, to propose corrective measures.

The competent authorities of each Member State must prepare reports on the observance of good manufacturing practices, which must be communicated upon request to the competent authorities of another Member State.

For the interpretation of the principles and guidelines of good manufacturing practice, the manufacturers and the competent authorities must refer to the guidelines set out in the "Good manufacturing practice guidelines" (EN).

With regard to veterinary medicinal products imported from third countries, importers must ensure that their manufacture conforms to standards equivalent to the good manufacturing practice developed by the Community. In addition, they must ensure that the persons manufacturing these are authorised manufacturers.

Manufacturers must set up a system for recording and reviewing complaints together with an effective system for recalling promptly the veterinary medicinal products in the distribution network. They must examine and record complaints regarding a quality defect, and must inform the competent authorities of any quality defect that may result in a recall or abnormal restriction on the supply. They must also indicate the countries of destination.

Key terms in the Act
  • Good manufacturing practice: the part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate to their intended use.
  • Manufacturer: any holder of the authorisation referred to in Article 44 of Directive 2001/82/EEC.
  • Pharmaceutical quality assurance: the sum total of the organised arrangements made in order to ensure that veterinary medicinal products are of the quality required for their intended use.

REFERENCES

ActEntry into forceDeadline for transposition in the Member StatesOfficial Journal
Directive 91/412/EEC20 days after publication in the Official Journal23.07.1993OJ L 228, 17.08.1991.

RELATED ACTS

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency [Official Journal L136, 30.04.2004].

Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products [Official Journal L 136, 30.04.2004].

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [Official Journal L 311 of 28.11.2001].

Last updated: 05.09.2007

See also

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