Glossary of pharmaceutical and GMP terms with explanations

In this section of GMP-inspection.com, our translators provide definitions and explanations of various specialized terms from the pharmaceutical industry and GMP (Good Manufacturing Practice).

Manufacture of animal drugs

The manufacture of animal drugs is regulated by regulatory authorities and requires strict compliance with quality and safety standards, similar to the manufacture drugs for humans.

The manufacture of animal drugs (British English: veterinary medicinal products) refers to the production of medicines for the treatment and prevention of diseases in animals and the maintenance of animal health. This process includes the development of formulations, efficacy and safety tests on animals, the scale-up of manufacturing processes and the quality control of the end products. Animal drugs can be developed for pets, livestock and special animal categories such as zoo or wild animals.

The most important stages in the manufacture of animal drugs (German translation: Tierarzneimittel) include:

  • Research and development: This stage serves to identify active pharmaceutical ingredients, investigate their pharmacological properties and develop formulations and dosages.
  • Clinical trials: Testing drugs on animals to assess their safety and efficacy and to determine the optimal dosage.
  • Development of manufacturing processes: Includes the transfer of laboratory methods to the industrial level, the selection of equipment and manufacturing processes (translation into German: Herstellungsverfahren).
  • Manufacture: The actual production of animal drugs, which includes the synthesis of the active pharmaceutical ingredients, the dosage form (tablets, injections, powder, etc.), the packaging and the labeling (German translation: Kennzeichnung) of the products.
  • Quality control: Laboratory tests and checks at every stage of production to ensure compliance with legal regulations and quality standards.
  • Marketing authorization: Preparation of the necessary documents and obtaining the official approval for the market launch of the animal drug.

Animal drugs serve to protect animal health, as they are used to treat and prevent diseases in animals.  In the case of farm animals, animal drugs also contribute to food safety, as the control of livestock diseases contributes to public health and food safety.  Maintaining animal health also has an impact on the economic efficiency of agricultural production: Healthy livestock means higher yields. The manufacture of animal drugs is regulated by regulatory authorities and requires strict compliance with quality and safety standards, similar to the manufacture drugs for humans.

Are you in the runup to a GMP inspection in a foreign language? Our pharmaceutical interpreters have many years of experience in accompanying GMP inspections at animal drug manufacturers. We are at your disposal!

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