Self-inspection is a process carried out by organizations in order to internally assess quality management systems, procedures, production processes and compliance with applicable standards and legal requirements. In the context of Good Manufacturing Practice (GMP; German translation: Gute Herstellungspraxis), self-inspection is a key element of a quality assurance system aimed at maintaining and improving production, product quality and safety standards.

Aims of a self-inspection (German translation: Selbstinspektion):

• Certifying conformity: Checking whether the existing processes and procedures comply with the established GMP standards and other legal requirements.
• Identification of problems and non-conformities: Identification of deviations (German: Abweichungen) or problems in the quality system, production processes or documentation management.
• Process improvement: Identification of areas in need of improvement and development of action plans to correct any non-conformities identified and optimize processes.
• Staff training: Training and raising employee awareness of GMP and quality assurance processes.

The most important aspects of self-inspection:

• Frequency: Self-inspections are usually carried out regularly, e.g. annually, to ensure continuous compliance with GMP regulations and process improvement.
• Self-inspection plan: Organizations develop self-inspection plans in which they define the areas and processes to be inspected, the staff responsible for carrying out the inspections and the schedule for carrying them out.
• Process of self-inspection: This includes the inspection of production facilities and equipment, the analysis of procedures and documentation, the assessment of staff qualifications and the quality management system.
• Report and improvement measures: Based on the results of the self-inspection, a report is compiled containing a description of the non-conformities identified and recommendations for their elimination. Measures of corrective and preventive action (CAPA; German: Korrektur- und Präventivmaßnahmen) are developed and implemented.

Self-inspection plays a crucial role in maintaining high standards of product quality and safety, helps prevent errors and defects in production processes and demonstrates a company’s commitment to good manufacturing practice to regulators.

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