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).

Pharmaceutical distribution

The main objective of pharmaceutical distribution is to ensure the availability, safety, efficacy and quality of drugs.

Pharmaceutical distribution is a process that encompasses all stages of the life cycle of a drug (British English: medicinal product), from research and development, including clinical trials, through manufacture, quality assurance, marketing authorization, storage, distribution and sale, to post-authorization monitoring and the collection of information on adverse drug reactions.

Many parties are involved in this process, including pharmaceutical companies, regulatory authorities, healthcare professionals and patients.

The main objective of pharmaceutical distribution (German translation: Arzneimittelverkehr) is to ensure the availability, safety, efficacy and quality of drugs. This includes the following aspects:

  • Research and development: In this stage, new active pharmaceutical ingredients (APIs; German: Wirkstoffe) and their pharmacological and toxicological properties are investigated.
  • Clinical trials: Studies in humans to confirm the safety and efficacy of a drug.
  • Marketing authorization: The process of drug approval for the market by regulatory authorities.
  • Manufacture: Compliance with quality and safety standards for the large-scale manufacture of drugs.
  • Quality control: Checking the quality of products at every stage of their manufacture.
  • Storage and distribution: Proper storage and transportation conditions for drugs must be ensured.
  • Dispensation: With a few exceptions, in Germany, drugs may only be dispensed in pharmacies due to requirements under German law.
  • Pharmacovigilance: Monitoring the efficacy and safety of a drug after marketing authorization, including the collection of information on side effects and interactions (German translation: Wechselwirkungen) with other drugs.
  • Information and education: Providing accurate information on drugs for healthcare professionals and patients.

Pharmaceutical distribution is regulated at national and international levels by various laws and regulations that are intended to ensure drug safety and efficacy. In Germany, this purpose is mainly fulfilled by the German Medicinal Products Act (Arzneimittelgesetz).

If you are looking for experienced GMP translators and pharmaceutical interpreters, you will find them here. Contact us for a quote for pharmaceutical translations or interpreting services and we will be more than happy to help you.

Go back