During a pharmaceutical production audit, the quality assurance system, manufacturing processes, equipment, documentation and other aspects related to the manufacture of drugs or medical devices are independently reviewed and evaluated. The goal of this type of audit is to ensure that the manufacturer complies with the established standards of Good Manufacturing Practice (GMP) (translation into German: Gute Herstellungspraxis) and other applicable rules, regulations and regulatory requirements.

Pharmaceutical production audits can be carried out by various bodies:

Internal audit (self-inspection): An internal audit is conducted by representatives of the pharmaceutical company itself to assess and improve internal processes and compliance with GMP standards. It is an important tool for ensuring product quality and eliminating possible nonconformities (German translation: Nichtkonformitäten) before an audit is carried out by external organizations.

External audits by regulatory authorities (GMP inspections): Health and regulatory authorities may conduct audits of drug (British English: medicinal products) and medical device manufacturers to verify compliance with GMP standards and other regulatory requirements. These audits can be scheduled or unscheduled.

External audits by customers or contractors: Pharmaceutical companies can also ask third-party organizations or their customers to audit their production to further ensure product quality.

During a pharmaceutical production audit, several aspects are checked, such as

• Compliance with production processes and procedures
• Quality control (German: Qualitätskontrolle) of products and processes
• Equipment and its calibration
• Documentation and archiving systems
• Training and qualification of personnel
• Hygienic conditions and cleanliness of production facilities
• Ensuring safety and avoiding potential risks

Based on the results of audits, suggestions for improvements can be made and nonconformities can be identified and eliminated. In addition, the audit or inspection results can be used to decide whether to grant or extend a manufacturing authorization (German translation: Herstellungserlaubnis) for pharmaceutical products. Audits are an important part of quality assurance, ensuring a high level of product safety and quality, which is ultimately crucial for patient health.

Our language professionals are happy to take on the pharmaceutical translation of your pharmaceutical documents (inspection reports, SOPs, etc.) and accompany you as pharmaceutical interpreters during GMP inspections by foreign authorities.

Our range of services also includes consultancy services, representation of foreign pharmaceutical companies and the distribution of their products in Germany. Thanks to our long-standing cooperation with a host of companies around the world, we can also facilitate talent recruitment in the pharmaceutical industry and match professionals with great job opportunities. Looking for a new pharmaceutical job in your dream country? Contact us for more information!