30 Common Ways to Avoid the Most Frequent GMP Errors
✅ 30 Common Ways to Avoid the Most Frequent GMP Errors
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Follow approved SOPs strictly.
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Ensure proper documentation – never backdate or predate entries.
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Maintain good record-keeping practices (ALCOA+ principles).
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Always perform line clearance before starting new activities.
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Follow labeling controls to avoid mix-ups.
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Conduct proper training and retraining of personnel.
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Ensure calibration of instruments on schedule.
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Perform equipment qualification (IQ/OQ/PQ) before use.
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Avoid cross-contamination with proper cleaning and segregation.
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Implement environmental monitoring in critical areas.
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Verify raw material identification before use.
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Store materials in designated areas with proper labeling.
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Maintain temperature and humidity controls in storage areas.
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Ensure validated cleaning procedures for equipment.
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Handle deviations promptly with investigation and CAPA.
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Perform in-process controls during manufacturing.
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Check expiry dates of materials before use.
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Implement change control for any process/equipment modification.
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Ensure data integrity in all records (no alterations without justification).
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Validate computerized systems used in GMP operations.
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Maintain personal hygiene and GMP gowning standards.
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Control restricted access to critical areas.
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Conduct risk assessments for critical processes.
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Ensure document version control to avoid outdated SOPs.
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Maintain traceability of materials and products.
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Conduct mock recalls and maintain recall readiness.
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Monitor supplier qualification and incoming material testing.
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Implement effective CAPA system to prevent recurrence.
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Perform self-inspections and internal audits regularly.
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Foster a quality culture – encourage reporting of errors without fear.
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