Herbal raw materials — fresh or dried plants or parts thereof used for the manufacture of drugs by pharmaceutical manufacturers, pharmacies, veterinary pharmaceutical entrepreneurs or sole proprietors authorized to manufacture pharmaceutical products.

Herbal raw materials (translation into German: pflanzliche Ausgangsstoffe) can be used to obtain powders or extracts, for example, which are then used to produce capsules and other dosage forms. They are an important component of many traditional and alternative therapies. However, herbal raw materials can also be found in allopathy and can be used to obtain highly potent APIs such as paclitaxel. This is a cytostatic substance that can be extracted from the Pacific yew tree.

Compliance with GMP standards for herbal raw materials ensures a high level of quality, safety and efficacy of the drugs manufactured from them. Some of the aspects that are regulated under the GMP guidelines for herbal raw materials are:

• Identification: It must be ensured that the plants and plant parts used as raw material are clearly identified and correspond to the information on the label and the certificate of analysis.
• Collection and storage: The raw materials must be collected, handled and stored, taking into account their purity and quality in order to avoid impurities (German translation: Verunreinigungen) and impairments.
• Analysis and testing: The raw materials must be analyzed for active pharmaceutical ingredient content in order to control the quality and check compliance with the specifications.
• Processing and extraction: The processing and extraction methods for herbal raw materials should be designed and monitored to ensure consistent and predictable quality.
• Quality control: The manufacturing and quality control procedures must comply with GMP guidelines and specifications.
• Risk management: Identification and management of potential risks in relation to herbal raw materials.
• Documentation: All information on the origin, processing, analysis and other aspects of the herbal raw materials must be documented.

The herbal raw materials used and processed in accordance with GMP guidelines have a high level of quality and safety, which is important for the efficacy (German: Wirksamkeit) of the drugs manufactured from them.

As experts in pharmaceutical and GMP interpreting, we are happy to provide language support for the GMP inspection of your pharmaceutical company. We also prepare pharmaceutical translations in our core languages English, Russian and German at relatively short notice and on a large scale.

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