Self Inspection and Quality Audits
Self-Inspection and Quality Audits in Pharmaceuticals
1. Self-Inspection
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Definition: An internal examination carried out by the company itself to evaluate compliance with GMP, SOPs, and regulatory standards.
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Purpose:
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Detect deficiencies in the quality system.
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Verify that manufacturing, QC, and warehouse operations comply with GMP.
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Promote continuous improvement and readiness for external inspections.
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Scope:
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Personnel practices and training.
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Facilities and equipment (cleaning, calibration, maintenance).
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Documentation and records.
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Production processes, validation, and deviations.
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Laboratory controls, data integrity, and OOS/OOT handling.
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Distribution, complaints, and recall procedures.
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Frequency:
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At least once a year for each department, but can be more frequent based on risk.
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Outcome:
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Written report with observations, classification of findings (critical, major, minor).
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CAPA implementation and effectiveness checks.
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2. Quality Audits
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Definition: A systematic, independent examination to determine whether activities and results comply with planned arrangements and regulatory requirements.
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Types of Quality Audits:
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Internal Audit (First-Party): Conducted within the company by independent QA personnel.
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Supplier/Vendor Audit (Second-Party): Performed at supplier/contract manufacturer sites to qualify and monitor them.
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Regulatory/Customer Audit (Third-Party): Performed by FDA, EMA, WHO, or clients.
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Purpose:
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Verify the effectiveness of the Quality Management System (QMS).
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Ensure suppliers/CMOs meet GMP and quality standards.
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Prepare for external inspections.
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Scope:
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Covers QMS elements such as training, documentation, change control, deviation/CAPA, validation, equipment, utilities, data integrity, etc.
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3. Differences Between Self-Inspection and Quality Audit
| Aspect | Self-Inspection | Quality Audit |
|---|---|---|
| Performed by | Company staff (internal) | Internal QA team, external auditors, or regulators |
| Frequency | At least annually | Scheduled or regulatory demand |
| Focus | GMP compliance and internal improvement | GMP compliance, supplier qualification, regulatory oversight |
| Independence | Less independent (done internally) | More independent/objective |
| Outcome | Internal report + CAPA | Report + CAPA, may affect approvals or supplier qualification |
4. Importance in Quality Systems
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Identifies gaps before regulators do.
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Strengthens data integrity and compliance culture.
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Helps maintain a state of audit readiness.
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Ensures continuous quality improvement.
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Reduces the risk of 483 observations, warning letters, and recalls.
✅ Key Takeaway:
Both self-inspection and quality audits are integral to a pharmaceutical quality system. While self-inspections focus on internal compliance and improvement, quality audits extend to suppliers, contractors, and regulatory oversight. Together, they ensure GMP compliance, patient safety, and business continuity.
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