The qualified person is a key figure in GMP inspections. As the legally defined person responsible for batch release, she ensures compliance with Good Manufacturing Practice and acts as the central interface to the authorities. This article sheds light on tasks, risks and responsibilities.

Responsibility of the qualified person in the GMP system

The qualified person assumes a central role for quality assurance and regulatory compliance within the framework of Good Manufacturing Practice (GMP). It ensures that each batch has been manufactured and tested in accordance with the requirements of good manufacturing practice. During a GMP inspection, a particular focus is placed on the traceability of batch documentation, compliance with standard operating procedures (SOPs) and the correct implementation of deviation management and change management. In this context, close dovetailing with areas such as quality assurance and quality control is also crucial.

Role of the qualified person during the inspection

During a GMP inspection, the qualified person acts as the central contact person for inspectors. They must be able to present processes clearly and answer critical questions about production, testing and approval. Terms such as validation, qualification and risk management play a key role here. The qualified person is also responsible for the evaluation of deviations and the decision to release or block batches. Transparent communication and in-depth knowledge of regulatory requirements are essential in this context, particularly in the context of GMP inspections and pharmaceutical production audits.

Interfaces and cooperation within the company

The qualified person works closely with various departments rather than in isolation. This includes production, quality control and quality assurance. Effective collaboration is necessary to fulfil inspection requirements and ensure continual improvement. Areas such as documentation, training and self-inspection play a key role in this regard. Coordination with areas such as production and supplier qualification is also essential in order to ensure consistent compliance along the entire supply chain.

Risks and typical observations during inspections

Typical complaints during GMP inspections concern inadequate documentation, gaps in deviation management or weaknesses in validation. The qualified person must recognise these risks at an early stage and take appropriate action. Structured preparation for inspections and regular internal audits are crucial for minimising deviations. The focus is on compliance with regulatory requirements and the continuous improvement of processes.

Accurate and technically sound communication is the foundation for successful GMP inspections, particularly when interacting with regulatory authorities and international partners. We are happy to support you with experienced pharmaceutical interpreters and pharmaceutical translations at the highest level in order to convey content safely, consistently and with regulatory clarity.

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