The GMP inspection agenda is a document that describes the schedule, objectives and individual steps of a GMP inspection at a pharmaceutical manufacturing site. It is drawn up by regulatory authorities (German translation: Zulassungsbehörden) or GMP inspectorates based on the GMP guidelines and contains the following key data:

• Type of inspection: An upcoming GMP inspection is defined as either a routine (German: planmäßig), for-cause (German: außerplanmäßig) or follow-up inspection (German: Nachinspektion).
• Subject of the inspection: The company to be inspected, the registered drug (German translation: Arzneimittel) and the production areas and processes involved in its manufacture are included.
• Objectives of the inspection: Specific objectives are described, e.g. checking compliance with GMP guidelines, evaluating the elimination of deficiencies and confirming storage and production conditions are GMP-compliant.
• Structure of the inspection team: GMP inspectors are appointed, and one of them is appointed lead inspector.
• Time frame: The days on which the GMP inspection is scheduled to take place are specified.
• Daily schedule: A schedule is drawn up for each day of the GMP inspection.

To ensure that the GMP inspection runs smoothly, the GMP inspection agenda should be communicated to the representatives of the company being inspected well in advance of the inspection. The GMP inspection agenda has the following advantages:

• Straightforward planning: The GMP inspection agenda clearly defines which areas of production are to be inspected, allowing the GMP inspectors to better understand what to look for and the pharmaceutical company to be better prepared for the inspectors’ questions.
• Resource optimization: Using the inspection agenda, staff and time resources can be allocated in advance and the GMP inspection can be planned in such a way that the company’s employees are distracted as little as possible from their work.

The GMP inspection agenda is an integral part of the preparation and execution of inspections at pharmaceutical companies and increases the transparency and efficiency of an audit.

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