According to the German Medicinal Products Act (AMG), drugs (British English: medicinal products) are “substances or preparations made from substances […] intended for use in or on the human body and are intended for use as remedies with properties for the curing, alleviating or preventing of human diseases or disease symptoms.”

They are used to "restore, correct or influence the physiological functions through a pharmacological, immunological or metabolic effect, or to make a medical diagnosis (German translation: Diagnose).” In most cases, drugs are obtained by chemical synthesis processes, but they can also be obtained from blood, blood plasma, human or animal body tissue, plants, minerals or by using biotechnologies.

Drugs are available in the form of tablets, capsules, injection solutions, creams, ointments, solutions, syrups, aerosols and many other dosage forms.

Drugs (German translation: Arzneimittel) must be manufactured and packaged in accordance with GMP guidelines in order to guarantee their quality, efficacy and safety. This means that all aspects of production, from the selection of substances to the packaging of the finished products, must comply with legal requirements and GMP standards.

The most important aspects governed by the GMP guidelines for drugs include:

• Identification, impurities and assay: Each drug must be clearly identified and tested for specific impurities and its content.
• Formulation and manufacturing process: The formulation of each drug must be defined and the manufacturing processes should be designed to ensure consistent and predictable quality.
• Quality control: All stages of drug manufacturing (German translation: Arzneimittelherstellung), including raw materials, intermediates and finished products, must be subject to quality control in accordance with the established specifications.
• Documentation: All information about production, quality and quality control must be documented to ensure transparency and traceability (German: Nachverfolgbarkeit).
• Storage and transport: To ensure the quality and safety of drugs, they must be stored and transported in compliance with certain regulations, e.g. with regard to temperature.
• Risk management (translation into German: Risikomanagement): Identification and management of potential risks associated with drugs in order to avoid potential problems.
• Stability test: Drugs must undergo stability testing to ensure that quality and efficacy can be guaranteed for the complete duration of their shelf life.

For GMP inspections by, for example, American, Belarusian or Russian authorities such as the FDA or SID&GP, we are happy to provide our services to your company as professional GMP translators and pharmaceutical interpreters and ensure flawless communication between the team of inspectors and the pharmaceutical company. Contact us for a quote!

We also offer various types of consultancy services in the run-up to a GMP inspection, representation of international pharmaceutical companies and distribution of their products in Germany. Thanks to our long-standing cooperation with many pharmaceutical companies around the world, we can also support you if you are looking for a new job in the pharmaceutical industry.