Manufacture of drugs — According to Section 4 (14) of the German Medicinal Product Act, the manufacture of drugs includes “the extraction, production, preparation, treatment or processing, transferring including filling, packaging, labelling and release.” This means that precise regulations also apply to supposedly trivial process steps.

The manufacture of drugs (British English: medicinal products) in accordance with Good Manufacturing Practice (translation into German: Gute Herstellungspraxis) is a systematic and structured process designed to achieve a high level of quality, safety and efficacy. Compliance with GMP guidelines creates a certain level of trust in drugs based on strict standards and requirements.

The GMP-compliant manufacture of drugs includes the following key aspects:

• Design and infrastructure: Production rooms, facilities and infrastructure must be designed and organized in such a way that contamination can be avoided and cleanliness and safety can be guaranteed.
• Raw materials: All raw materials used in production must meet the required quality standards and be thoroughly tested to ensure compliance with specifications (German translation: Spezifikationen).
• Production processes: Production processes must be optimized, documented and monitored in order to ensure consistent and predictable product quality.
• Quality control: Quality control must take place at all stages of production, including analyses and tests of the products to ensure that they meet the specified standards.
• Risk management: Identifying and managing potential risks in connection with production and product quality.
  Staff qualification and training: The employees working in production must be trained and qualified to fulfill their tasks.
• Documentation and records: All processes and activities in connection with production, quality control and other aspects must be documented (German: dokumentieren) in a transparent manner.
• Compliance with standards and requirements: Manufacturing must comply with GMP guidelines and other legal standards.
  Stability and storage: Products must be stable throughout the duration of their shelf life and storage conditions must be complied with as prescribed.

The GMP-compliant manufacture of drugs ensures that each stage of production is carried out with care and precision in order to minimize the risks for patients and to ensure that the drugs meet high standards of quality, safety and efficacy.

If your pharmaceutical company also has an upcoming GMP inspection by foreign authorities, we are happy to support you with our language expertise. Ask us for a quote today! Our pharmaceutical interpreters and GMP translators ensure flawless communication.

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