A follow-up GMP inspection is a control measure carried out by regulatory authorities. Its purpose is to evaluate the implementation of corrective and preventive actions (CAPA) by a company after deficiencies have been identified during a previous GMP inspection.

The purpose of a follow-up GMP inspection is to ensure that the pharmaceutical company has made changes to its processes, equipment, documentation and manufacturing conditions that ensure its full compliance with the guidelines of Good Manufacturing Practice (GMP; German translation: Gute Herstellungspraxis).

Key points of a follow-up GMP inspection:

• Checking whether deficiencies have been remedied: The inspectors check whether corrective actions (German: Korrekturmaßnahmen) have been implemented and whether all critical, major or other deficiencies identified have been rectified.
• Document review: GMP inspectors review documents and records for the complete and timely implementation of all CAPA measures.
• Repeat audit: The production areas are inspected and the processes are checked again to ensure that the deficiencies have actually been eliminated and that no new risks have emerged.

The importance of a follow-up GMP inspection:

A follow-up GMP inspection ensures that the company has not only eliminated specific deficiencies but has also improved its pharmaceutical quality system (translation into German: pharmazeutisches Qualitätssystem) to ensure GMP compliance in the future as well. If the company successfully passes the follow-up GMP inspection, this serves as confirmation that the company is capable of manufacturing safe and high-quality products that comply with legal requirements.

If a GMP inspection by regulatory authorities from the EU, the USA or the EAEU is scheduled at one of your company’s production sites, our professional pharmaceutical interpreters are at your disposal!

They ensure smooth communication between the FDA, EMA or SID&GP inspectors and the site representatives.

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