Standard Operating Procedure (SOP) for Self Inspection and Internal Audits

Cleaning of High Performance Liquid Chromatography (HPLC)

I. Introduction

1.1 Background

  • Provide an overview of the organization’s commitment to quality assurance and continuous improvement.
  • Explain the importance of self-inspection and internal audits in identifying areas for enhancement and ensuring compliance.

1.2 Purpose of the SOP

  • Clearly state the purpose of the SOP, which is to establish guidelines and procedures for conducting effective self-inspections and internal audits.

II. Scope

2.1 Inclusions

  • Specify the departments, processes, and activities covered by this SOP.
  • Identify the key personnel responsible for conducting self-inspections and internal audits.

2.2 Exclusions

  • Define any areas or processes that are not part of the scope of this SOP and provide reasons for their exclusion.

III. Definitions

3.1 Self Inspection

  • Define self-inspection and its role in evaluating internal processes, practices, and compliance.

3.2 Internal Audit

  • Provide a clear definition of internal audits and their purpose in assessing the effectiveness of the organization’s quality management system.

IV. Roles and Responsibilities

4.1 Quality Assurance Team

  • Describe the responsibilities of the quality assurance team in planning, executing, and documenting self-inspections and internal audits.

4.2 Department Heads

  • Explain the role of department heads in facilitating the audit process and addressing findings within their respective areas.

V. Self Inspection Process

5.1 Planning

  • Describe the process of planning self-inspections, including selecting areas for evaluation, setting objectives, and creating an inspection schedule.

5.2 Inspection Execution

  • Detail the steps involved in conducting self-inspections, such as data collection, observations, and document reviews.

5.3 Findings and Reporting

  • Explain how inspection findings are documented, categorized, and reported to relevant stakeholders.
  • Address the process of identifying root causes and potential corrective actions.

VI. Internal Audit Process

6.1 Audit Planning

  • Describe the process of planning internal audits, including scoping, defining audit criteria, and establishing an audit plan.

6.2 Audit Execution

  • Detail the steps for conducting internal audits, including interviews, document reviews, and evidence collection.

6.3 Audit Findings and Reporting

  • Explain how audit findings are documented, evaluated, and reported.
  • Describe the process of developing corrective and preventive action plans.

VII. Corrective and Preventive Actions

7.1 Corrective Actions

  • Detail the procedures for addressing identified non-conformities and implementing corrective actions.
  • Explain the process of verifying the effectiveness of corrective actions taken.

7.2 Preventive Actions

  • Describe how potential issues are proactively identified and addressed through preventive actions.
  • Highlight the importance of continuous improvement.

VIII. Documentation

8.1 Self Inspection Records

  • Specify the information that should be documented during self-inspections, including checklists, observations, and findings.

8.2 Internal Audit Reports

  • Explain the content and format of internal audit reports, including audit scope, findings, and recommendations.

IX. Training and Competency

9.1 Training Programs

  • Describe the training initiatives for individuals involved in self-inspections and internal audits.
  • Emphasize the importance of maintaining up-to-date skills and knowledge.

X. Review and Approval

10.1 Review Process

  • Explain the process of reviewing and approving self-inspection reports and internal audit findings.
  • Highlight the role of management in ensuring accountability.

XI. Conclusion

11.1 Summary

  • Summarize the key components and objectives of the SOP for Self Inspection and Internal Audits.

11.2 Commitment

  • Express the organization’s commitment to regular self-inspections and internal audits as part of its quality assurance efforts.

11.3 Review and Updates

  • Address the periodic review and updating process for the SOP to ensure its continued relevance and effectiveness.

XII. Appendices

  • Attach any necessary templates, forms, or additional resources to support the self-inspection and internal audit processes.

Note: Customize the SOP according to the specific requirements and practices of your organization.

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Pharmacareer team is a team of Experts from every department of Pharmaceutical industry having enriched experience. Experts have work experience of many multinational pharmaceutical industries worldwide.

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