Good Manufacturing Practice (GMP, German: Gute Herstellungspraxis) is a system of guidelines and regulations for the manufacture of drugs, medical devices, diagnostics, food, food additives and active pharmaceutical ingredients. In contrast to quality control procedures, GMP reflects a holistic approach and regulates manufacturing parameters.

The basic principles and requirements of Good Manufacturing Practice include:

• Facilities and equipment: Production facilities and equipment must be clean, suitable for their purpose and regularly maintained. They are required to meet standards that ensure that the risk of product contamination (translation into German: Produktkontamination) is minimized.
• Staff: The employees working in the manufacturing area must be qualified and trained and comply with the hygiene and safety regulations. The staff requirements may vary depending on the type of product being manufactured.
• Documentation and records: All phases of production and quality control must be documented. This includes records of manufacturing instructions (German translation: Herstellungsanweisungen), specifications, procedures and quality control results. Documentation helps to ensure reliability and traceability of product quality.
• Quality control: Products must undergo strict quality control (German: Qualitätskontrolle) at all stages of manufacture, from the delivery of raw materials to the finished product. This includes analyses and tests to ensure that the products meet the defined specifications.
• Storage and shipping: The products must be stored and shipped in such a way that they do not spoil or become contaminated. This includes rules for storage at certain temperatures and in defined conditions.
• Change control (German: Änderungskontrolle): All changes to manufacturing processes or products must be documented and evaluated with regard to their impact on product quality and safety.
• Responsibility for quality: Manufacturing companies must have a quality management system and designated persons responsible for ensuring compliance with the GMP guidelines.
• Audits and inspections: The production facilities are subject to audits and inspections by the competent authorities to ensure compliance with GMP guidelines.

Compliance with Good Manufacturing Practice is mandatory for pharmaceutical companies, food manufacturers, medical device manufacturers and other organizations that manufacture products that may affect human health. The GMP guidelines help to protect consumers, ensure product safety and prevent potential problems with product quality.

We can provide you with competent pharmaceutical interpreters and GMP translators for your GMP inspection in Russian or English. They take care of communication so that you can concentrate on the technical content. We also offer various types of consultancy services, representation of foreign pharmaceutical companies and distribution of their products in Germany. Simply contact us for a quote!