OBJECTIVE:

• The objective of this SOP is to establish a systematic and documented procedure for conducting self-inspections to verify compliance with EU GMP, WHO, FDA, and other applicable regulatory requirements. This SOP ensures:
• • • Continuous compliance with cGMP.
    • Early identification of potential gaps affecting product quality, patient safety, and regulatory compliance.
    • Implementation of effective Corrective and Preventive Actions (CAPA).
    • Promotion of a culture of continuous improvement.

SCOPE:

• This SOP applies to all departments, including but not limited to:
  • • Quality Assurance (QA)
    • Pharmacovigilance (PV)
    • Production & Warehouse
    • Quality Control (QC)
    • Regulatory Affairs (RA)
    • Engineering, IT, HR (as applicable)
• It covers planning, execution, documentation, reporting, and closure of self-inspections.

RESPONSIBILITIES:

• Quality Assurance (QA)
• • • Develop and maintain the Annual Self-Inspection Calendar.
    • Appoint trained and qualified inspectors.
    • Ensure follow-up and closure of CAPA.
    • Submit summary reports to senior management.

• Department Heads / Auditees
  • Facilitate access to facilities, records, and personnel.
  • Provide timely response to non-conformances.
  • Implement corrective actions within agreed timelines.
• Self-Inspection Team:
  • Conduct independent inspections as per schedule.
  • Document all findings in inspection checklist/report.
  • Classify observations (Critical, Major, Minor, Recommendations).

• Senior Management:
  • Review self-inspection reports and CAPA effectiveness.
  • Ensure resources are available for implementation of improvements.

DEFINATIONS:

• Self-Inspection: An internal audit conducted to assess compliance with GMP requirements.
•  Auditor Independence: Inspectors must not audit their own department to ensure impartiality.
• CAPA: Corrective and Preventive Actions taken to eliminate root causes of non-compliance.
• Observation Categories:
  • Critical: Directly impacts product quality, patient safety, or regulatory compliance → Immediate action required.
  • Major: Significant deviation from GMP that could indirectly affect product quality → High-priority correction.
  • Minor: Isolated or low-risk deviation → Correct within reasonable timeframe.

PROCEDURE:

Frequency:

• Self-inspections shall be conducted at least twice per year in each department, as per the approved Annual Self-Inspection Calendar. Additional inspections may be conducted:
• • • Before regulatory inspections.
    • After major changes in facilities, systems, or processes.
    • In response to repeated deviations or complaints.

Selection, Training & Qualification of Auditors:

• Inspectors must have scientific or technical qualifications (minimum graduate in Pharmacy, Science, or equivalent).
• At least 2 years of GMP-related experience required.

• Auditors shall undergo training on audit methodology, EU GMP / WHO TRS requirements, documentation, and CAPA handling.

• Auditor Qualification Matrix shall be maintained by QA.

Planning:

• Designee QA shall prepare Annual Self-Inspection Calendar in January each year and Calendar is approved by Head – QA/RA.

• Notification of inspections shall send to concerned departments 7 days in advance.

Execution:

• Inspection shall conduct by a team of at least two auditors, including one QA representative.           

• Inspectors must not belong to the department under inspection.
• Standardized departmental checklists shall be used.
• Inspectors shall review:
  • Facility & equipment condition
  • Documentation practices
  • Training & personnel practices
  • Production & QC records
  • Storage, distribution & warehouse practices
  • Pharmacovigilance records

Documentation:

• Observations shall be recorded in the Self-Inspection Observation Report (F/QA008/012 – 00).
•  Each observation classified as Critical / Major / Minor / Recommendation.
•  Report signed by all auditors and submitted to QA Head within 5 working days.

 CAPA Management:

• Designee QA shall compile Audit report after discussed with Audit team and it shall be finally approved by Head QA.
• Designee QA shall issue the Audit report to auditee within 7 working days.
•  Auditee shall submit CAPA plan within 15 working days.
• QA shall review CAPA and verify implementation. Closure shall be documented in Compliance Report (F/QA008/013 – 00).
• Unresolved issues shall be escalated to Senior Management.

 Follow-up:

• Effectiveness of CAPA shall be verified in the next inspection.
•  Repeated or non-implemented CAPA escalated as Major observation.

REFERENCE:

• EU GMP Guide, Part I, Chapter 9 – Self-Inspection
•  WHO GMP Guidelines (Annex 3, TRS 986, 2014)

 RECORDS:

 REVISION HISTORY.