The GMP inspectorate quality system of a GMP inspectorate is a cohesive unit of procedures, standards and methods for the planning, execution and evaluation of GMP inspections at pharmaceutical production sites (German translation: Produktionsstätten). The GMP inspectorate quality system serves to ensure the consistency, reliability and transparency of inspection procedures, which is necessary for a uniform approach to GMP inspections and a high level of trust in the inspection bodies.

The main objectives of the GMP inspectorate:

• Harmonization of inspection standards: Ensures that all inspection procedures including the inspection of production, storage (German: Lagerung), distribution and quality control comply with international and national standards. This makes the inspection results more reliable, increasing their international acceptance.
• Maintaining a high level of qualification among inspectors: The quality system provides for continuous professional development and certification of inspectors to ensure their knowledge of GMP requirements and inspection methods is up-to-date.
• Monitoring and quality improvement: The efficiency of inspection procedures is regularly evaluated as part of the quality system. In order to continuously improve the quality of inspections, GMP inspection methods are reviewed and updated.

Elements of the quality system of a pharmaceutical inspectorate:

• PIC/S (Pharmaceutical Inspection Co-operation Scheme): International guidelines to ensure uniform requirements for inspectors.
• ISO 19011: International standard for auditing management systems, in particular quality management systems.
• National and local GMP standards: e.g. FDA and EMA standards as well as national regulations governing how GMP inspections are carried out.

These norms and standards ensure that the quality system of the GMP inspectorate meets high and uniform requirements for all phases of pharmaceutical production inspections.

If your production site is due for a GMP inspection by foreign regulatory authorities, our professional pharmaceutical interpreters can help you to ensure smooth communication between your employees and the American, European or Russian inspector team.

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