Active pharmaceutical ingredient (API) — a substance with a pharmacological effect, regardless of the origin, which is intended for the manufacture of drugs and determines their efficacy.

Active pharmaceutical ingredients (abbreviation: APIs, German translation: Wirkstoffe) are usually produced by biotechnological or chemical synthesis. They are used as the main ingredient for various types of drugs (British English: medicinal products). Ingredients are dosed by weight, volume or the number of active units. Depending on the type of active pharmaceutical ingredient, the drugs can be used in sterile and non-sterile dosage forms (translation into German: Arzneiformen).

Active pharmaceutical ingredients must be manufactured and processed under strict GMP standards. The most important aspects that are taken into account in the manufacture of active pharmaceutical ingredients in accordance with GMP guidelines include:

• Testing for quality and identification: The active pharmaceutical ingredient must be clearly identified and its chemical structure fully determined.
• Raw materials: The raw materials and reagents (German: Reagenzien) used for drug manufacturing must comply with quality and safety standards.
• Manufacturing processes: The manufacturing processes should be designed and monitored in such a way that a consistent and predictable quality of the substance is guaranteed.
• Quality control: All steps in the manufacture of a drug must be subject to quality control in accordance with the defined specifications.
• Risk management: Identification and management of potential risks in relation to the active pharmaceutical ingredient.
• Documentation: All information on the manufacture, analysis and quality control of the active pharmaceutical ingredient must be documented.
• Stability testing: APIs must undergo stability testing in order to guarantee quality and efficacy for the duration of their shelf life.

Active pharmaceutical ingredients play a central role in the manufacture of drugs and have a direct influence on their quality and efficacy. The GMP guidelines ensure that active pharmaceutical ingredients are manufactured in accordance with high quality and safety standards.

Our pharmaceutical interpreters and GMP translators would be happy to take care of verbal communication during your GMP inspection and translate SOPs and other documents into English or Russian.

We also offer the following services: Consultancy in the run-up to a GMP inspection, representation of international pharmaceutical companies and distribution of their products in Germany. If you are looking for a new position in the pharmaceutical industry, we will be happy to support you with our contacts at a large number of pharmaceutical companies all over the world.