According to Section 55 of the German Medicinal Products Act, a pharmacopoeia is a “collection of recognized pharmaceutical rules on the quality, testing, storage, dispensing and designation of drugs and animal drugs and the substances used in their manufacture. The pharmacopoeia also contains rules regarding the quality of containers and wrappings.” In Germany, the rules of the European Pharmacopoeia, the German Pharmacopoeia and the Homeopathic Pharmacopoeia apply. However, other countries such as the USA and Japan have also published their own pharmacopoeias. A pharmacopoeia (German translation: Arzneibuch or Pharmakopöe) is an important instrument for all those working in the field of pharmacy and contains standards for the quality, efficacy and safety of drugs.

Important aspects of state pharmacopoeias:

• Standardization: A pharmacopoeia sets standards for the composition, purity, efficacy and quality of drugs. It specifies which ingredients the products must contain, which analytical methods must be used to test them and how they must meet these standards.
• Quality control: Pharmaceutical companies that manufacture drugs are obliged to comply with the rules laid down in the (national) pharmacopoeia. Quality control is carried out at all stages of production, from the raw materials to the finished dosage forms (translation into German: Fertigarzneimittel).
• Safety: The pharmacopoeia also lays out standards for drug safety, including the levels of impurities (German: Verunreinigungen) and toxic substances permitted.
• Efficacy: A pharmacopoeia contains information on which tests must be carried out to prove the efficacy of drugs.
• Issuance and updates: Pharmacopoeias are regularly updated in order to keep abreast of the latest scientific and medical developments and changes in legislation.
• Mandatory compliance: Pharmaceutical companies and organizations involved in the manufacture and sale of drugs must comply with the standards set out in the pharmacopoeia in order to obtain marketing authorization for their products.

The European Pharmacopoeia describes various physical methods such as thin-layer chromatography (translation into German: Dünnschichtchromatographie), assays and technical pharmaceutical procedures. This is followed by monographs on herbal medicinal drugs and active pharmaceutical ingredients. In addition to general information on the active pharmaceutical ingredient (API), identification, tests and assay of the respective API are described here. The pharmacopoeia serves as an important instrument for ensuring drug safety and efficacy and for quality control in the pharmaceutical industry.

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