A GMP inspection report (German translation: GMP-Inspektionsbericht) is a formal document prepared after an inspection at a pharmaceutical manufacturing site used to evaluate compliance with Good Manufacturing Practice (GMP) requirements. This report contains the results of the inspection, the deficiencies found and recommendations for corrective measures. An inspection report is an important tool for monitoring the quality of production and ensuring the safety of drugs.

The most important sections of an inspection report:

• Introduction:
  
  • A brief description of the purpose and objectives of the GMP inspection.
  • Date and place of the inspection.
  • Parties present during the inspection, including the inspection team and company representatives.
• Scope of the inspection:
  
  • List of processes, equipment and systems inspected during the GMP inspection. This includes production facilities, quality control systems, documentation, equipment, staff and more.
• Inspection methods:
  
  • A description of the methods and approaches used during the GMP inspection, such as on-site inspection, surveying employees, reviewing documentation and taking samples for analysis.
• Summary of deficiencies:
  
  • A list of identified violations or deficiencies, categorized according to their severity:
    • Critical deficiencies (German translation: kritische Mängel): serious violations that can  directly impact product quality and patient safety.
    • Major deficiencies (German translation: schwerwiegende Mängel): less critical but potentially dangerous violations that require attention and must be remedied.
    • Other deficiencies (German translation: sonstige Mängel): Nonconformities that have no significant impact on product quality but must be rectified in order to improve the quality management system.
• Recommendations:
  
  • Concrete proposals for corrective and preventive action (CAPA) to remedy the problems identified.
  • Deadlines for the implementation of the recommendations.
• Conclusions and overall evaluation:
  
  • General evaluation of production compliance with GMP requirements.
  • Recommendation on the issuance or suspension of the GMP certificate depending on the number and severity of deficiencies found.
• Supplementary documents:
  
  • Photos, copies of documents, analysis results and other information to support the results of the GMP inspection can be included in the annex.

Purpose of the inspection report:

• Documentation of results: The report, in which all aspects of the inspection are recorded, serves as an official document confirming the manufacturer’s compliance or non-compliance with GMP standards.
• Instrument for improving manufacturing quality: The deficiencies identified and the recommendations help the manufacturer to make the necessary changes to the production processes in order to promote product quality and improve compliance with standards.
• Regulatory control: Regulatory authorities use inspection reports when deciding whether to issue a certificate, whether products may be placed on the market or whether additional inspections are required.

The importance of the inspection report:

• Corrective measures: On the basis of the report, the manufacturer must draw up and implement corrective and preventive actions (CAPA; German translation: Korrektur- und Vorbeugemaßnahmen) to eliminate the identified deficiencies.
• Communication with regulatory authorities: The inspection report serves as a means of communication between regulatory authorities and the manufacturer and shows the extent of manufacturers’ compliance with GMP standards.
• Ensuring product quality: The report helps to ensure that all necessary requirements are met during manufacturing in order to guarantee high product quality and safety. By working through the identified deficiencies, the pharmaceutical company is simultaneously improving its pharmaceutical quality system.
• Regulatory requirement: The preparation and submission of inspection reports is a prerequisite for the issuance and renewal of a GMP certificate.
• Process transparency: The report enables the traceability of all identified problems and the corrective measures taken.

The inspection report is therefore a key document for ensuring the transparency and validity of inspections and serves as an important tool for compliance with GMP requirements in the pharmaceutical industry.

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