In the context of GMP and the pharmaceutical industry, a Qualified Person (QP; German: Sachkundige Person) is a trained person who is responsible for ensuring that products and manufacturing processes comply with established quality and safety standards. This role is particularly important in the pharmaceutical industry, where the Qualified Person has the authority to release drug batches to the market after thoroughly testing and confirming that they comply with all GMP guidelines.

The tasks of a Qualified Person include the following aspects:

• Release of product batches: The QP certifies that each batch (German: Charge) of a drug has been manufactured and tested in accordance with the law, GMP standards and the conditions of the approval certificate.
• Quality control: The QP checks whether the internal quality control system is functioning effectively and whether all quality control procedures have been carried out properly.
• Complete documentation: The Qualified Person ensures that all necessary records, including production and inspection records and quality assurance reports, are archived and made available in accordance with legal and regulatory requirements.
• Training and qualification: Anyone who wishes to work as a Qualified Person in Germany must have a license to practice as a pharmacist (translation into German: Apotheker) or have completed at least four years of scientific studies in certain fields and have at least two years of practical experience.
• Interaction with regulatory authorities: The QP can act as the main contact person between the pharmaceutical company and the regulatory authorities and provide the necessary documentation and information for inspections and inquiries.
• Investigation of deviations: The QP is responsible for investigating all product quality-related complaints and deviations that occur during the production process and for taking corrective action (German: Korrekturmaßnahmen).

In order to fulfill their duties, a Qualified Person must have appropriate training, experience in the pharmaceutical industry and a thorough knowledge of Good Manufacturing Practice (GMP), pharmaceutical legislation and quality assurance principles. Qualification and training requirements for Qualified Persons may vary from country to country, including the need for specialized courses or certifications.

The role of the Qualified Person is crucial to ensuring a high level of trust in pharmaceutical products among patients, healthcare professionals and regulatory authorities. It is a key position that contributes to the protection of public health by ensuring that all drugs on the market are safe and effective and comply with applicable regulations.

If you are looking for professional pharmaceutical interpreters to carry out a GMP inspection or audit in a foreign language, we look forward to your inquiry. We will be more than happy to provide you with an individual quote tailored to your wishes and requirements.