Gmp Audit Checklist
Good Manufacturing Practice (GMP) audits verify pharmaceutical, medical device, and food manufacturing compliance. This 12-section checklist covers quality systems, personnel training, facilities, and production controls required by FDA and international regulators. Verify equipment qualification (IQ/OQ/PQ), process validation, and cleaning validation. Check laboratory controls, raw material testing, and batch record documentation. Review packaging controls, quality assurance procedures, and deviation management. Includes validation master plans, change control, and warehouse distribution. Essential for maintaining FDA registration, ISO certifications, and customer audits. Typical audit duration: 2-5 days.
Quality Management System
□ Quality manual current and complete
□ SOPs comprehensive and current
□ Document control system effective
□ Change control procedures followed
□ Training program documented
□ Management review conducted
□ Quality objectives defined
□ Risk management implemented
□ CAPA system functioning
□ Internal audit program active
□ Supplier qualification maintained
□ Customer complaint handling effective
Personnel & Training
□ Organizational chart current
□ Job descriptions defined
□ Qualification requirements met
□ Training matrix maintained
□ Training records complete
□ Competency assessments done
□ GMP training provided
□ Hygiene training conducted
□ Safety training current
□ Visitor policies enforced
□ Health monitoring active
□ Personal protective equipment used
Facilities & Equipment
□ Facility design appropriate
□ Clean rooms classified properly
□ Environmental monitoring active
□ Temperature/humidity controlled
□ Air handling systems validated
□ Water systems qualified
□ Equipment qualified (IQ/OQ/PQ)
□ Preventive maintenance scheduled
□ Calibration program current
□ Cleaning validation complete
□ Pest control program effective
□ Waste management appropriate
Raw Materials & Components
□ Supplier approval process documented
□ Incoming inspection performed
□ Sampling plans appropriate
□ Testing procedures validated
□ Specifications defined
□ Certificate of analysis verified
□ Quarantine procedures followed
□ Release procedures documented
□ Storage conditions maintained
□ Inventory control effective
□ Expiry dating managed
□ Rejected material controlled
Production & Process Controls
□ Master batch records approved
□ Batch records complete
□ Process validation current
□ In-process controls defined
□ Critical parameters monitored
□ Deviations investigated
□ Line clearance performed
□ Equipment logs maintained
□ Yield calculations done
□ Reconciliation performed
□ Time limits established
□ Environmental conditions monitored
Laboratory Controls
□ Laboratory qualified
□ Test methods validated
□ Reference standards managed
□ Reagents controlled
□ Sample management effective
□ Testing timelines met
□ OOS investigations thorough
□ Stability program comprehensive
□ Retain samples stored
□ Data integrity ensured
□ Equipment calibrated
□ Training documented
Packaging & Labeling
□ Packaging components controlled
□ Label control procedures effective
□ Line clearance verified
□ Print verification performed
□ Coding equipment validated
□ Reconciliation conducted
□ Obsolete labels destroyed
□ Storage conditions appropriate
□ Gang printing prohibited
□ Version control maintained
□ Customer requirements met
□ Regulatory compliance ensured
Quality Control & Assurance
□ Specifications established
□ Sampling procedures defined
□ Testing procedures validated
□ Release criteria clear
□ Batch release authorized
□ Stability studies conducted
□ Trend analysis performed
□ Product quality reviews done
□ Change control assessed
□ Validation master plan current
□ Risk assessments conducted
□ Continuous improvement active
Documentation & Records
□ GDP (Good Documentation Practices) followed
□ Records contemporaneous
□ Data integrity maintained
□ Electronic records compliant (21 CFR Part 11)
□ Batch records reviewed
□ Deviations documented
□ Investigations thorough
□ Retention periods followed
□ Archive system secure
□ Audit trail maintained
□ Document retrieval efficient
□ Destruction procedures controlled
Validation & Qualification
□ Validation master plan current
□ Equipment qualification complete
□ Process validation performed
□ Cleaning validation done
□ Computer system validation current
□ Method validation complete
□ Revalidation scheduled
□ Change impact assessed
□ Protocols approved properly
□ Reports reviewed and approved
□ Deviations addressed
□ Acceptance criteria met
Warehouse & Distribution
□ Storage conditions maintained
□ Temperature mapping done
□ Monitoring systems calibrated
□ FIFO/FEFO practiced
□ Segregation areas defined
□ Security measures adequate
□ Shipping validation performed
□ Cold chain maintained
□ Distribution records complete
□ Returns handled properly
□ Recall procedures ready
□ Traceability ensured
Regulatory Compliance
□ Regulatory requirements identified
□ Licenses/permits current
□ Regulatory submissions timely
□ Inspection readiness maintained
□ Regulatory changes tracked
□ Commitments tracked
□ Compliance metrics monitored
□ Audit findings addressed
□ CAPA effectiveness verified
□ Management oversight active
□ Continuous improvement demonstrated
□ Best practices implemented
How the Gmp Audit Checklist works
Pre-audit: Request quality manual, SOPs, organizational chart, training matrix, validation master plan, and last 3 batch records. Onsite day 1: Review documents, interview quality manager, tour facility. Day 2: Observe production, check equipment calibration stickers, review environmental monitoring data. Day 3: Inspect laboratory, review stability data, check warehouse temperature logs. Interview operators about procedures. Verify 20-30 random records for completeness. Check CAPA system for trending. Write findings report with observations, non-conformances, and improvement recommendations. Schedule closeout meeting.
GMP violations trigger FDA warning letters, import bans, and product recalls. Non-compliance costs average $5-15 million in remediation and lost sales. This checklist prevents manufacturing defects causing patient harm or product failures. Companies maintaining GMP reduce batch failures 60-80% and speed up regulatory approvals. Systematic audits identify risks before inspections. Good documentation proves due diligence during investigations. Regular GMP compliance builds customer confidence and opens new markets requiring certification.
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