MHRA GDP Good Distribution Practice Pharmaceutical Warehouse Audit
This checklist covers compliance with Manual Handling Operations Regulations 1992 (as amended 2002) and applicable UK statutory requirements for manufacturing operations. Non-compliance can result in unlimited fines and enforcement action under the Health and Safety at Work etc. Act 1974 and applicable UK statutory instruments.
- Industry: Manufacturing
- Frequency: Quarterly
- Estimated Time: 20-30 minutes
- Role: Distribution Quality Manager
- Total Items: 20
- Compliance: Manual Handling Operations Regulations 1992 (as amended 2002), HSE L23, BS EN 1005-2, Health and Safety at Work etc. Act 1974
Statutory Compliance, Registration & Risk Assessment
Verify statutory registrations, risk assessments, and Competent Person designation per UK law.
- Are all relevant statutory licences, permits, and registrations current, displayed where required, and available for inspection?
- Has a suitable and sufficient risk assessment been completed and communicated to relevant workers?
- Is a Competent Person designated for this area of compliance per the relevant statutory requirement?
- Attach photo of statutory registrations, risk assessment, and Competent Person appointment documentation:
Competence, Monitoring & Outstanding Actions
Verify worker competence, active monitoring programme, and outstanding corrective actions.
- Are all workers competent for their tasks (trained, experienced, or supervised as appropriate)?
- Is monitoring and measurement of key compliance indicators carried out at required frequencies?
- Number of outstanding corrective actions from previous inspection or audit:
- Attach photo of training records, monitoring reports, and corrective action tracker:
Emergency Procedures, Signage & Legal Notices
Verify emergency procedures, mandatory statutory signage, and drill records.
- Are emergency procedures documented, practiced through drills, and records maintained?
- Are all statutory notices, signage, and warnings correctly displayed per applicable regulations?
- Overall compliance with applicable UK statutory requirements:
- Attach photo of emergency drill records, statutory signage register, and compliance certificates:
Enforcement Compliance & Management Review
Verify enforcement notice compliance, management review programme, and senior accountability.
- Have all findings from previous regulatory inspections, enforcement notices, and prohibition orders been resolved?
- Is management review of the health and safety management system conducted at least annually?
- Number of open enforcement actions or improvement notices outstanding:
- Senior Responsible Officer certification of inspection completion:
Corrective Actions & Inspector Sign-Off
Document all deficiencies and assign corrective actions. POPProbe auto-assigns these to team members, generates a signed PDF report instantly, and tracks compliance status across all locations. -> Start free, no credit card required
- List all deficiencies identified in this inspection:
- Overall compliance status?
- Corrective actions assigned to (name and department):
- Inspector digital signature and date:
Related Manufacturing Checklists
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- ISO 45001:2018 Clause 6.1.2 Hazard Identification & OH&S Risk Audit
- ISO 45001:2018 Clause 6.1.3 Legal & Other Requirements Register UK
- ISO 45001:2018 Clause 5.4 Worker Participation & Consultation Audit
- EPR 2016 Environment Agency Environmental Permit Compliance Audit
- Environmental Protection Act 1990 Waste Management Licence Audit
- EPR 2016 Water Discharge Consent Monitoring Compliance Audit
- EPR 2016 Industrial Emissions Permit Air Quality Compliance Audit
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Why Use This MHRA GDP Good Distribution Practice Pharmaceutical Warehouse Audit?
This mhra gdp good distribution practice pharmaceutical warehouse audit helps manufacturing teams maintain compliance and operational excellence. Designed for distribution quality manager professionals, this checklist covers 20 critical inspection points across 5 sections. Recommended frequency: quarterly.
Ensures compliance with Manual Handling Operations Regulations 1992 (as amended 2002), HSE L23, BS EN 1005-2, Health and Safety at Work etc. Act 1974. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the MHRA GDP Good Distribution Practice Pharmaceutical Warehouse Audit cover?
This checklist covers 20 inspection items across 5 sections: Statutory Compliance, Registration & Risk Assessment, Competence, Monitoring & Outstanding Actions, Emergency Procedures, Signage & Legal Notices, Enforcement Compliance & Management Review, Corrective Actions & Inspector Sign-Off. It is designed for manufacturing operations and compliance.
How often should this checklist be completed?
This checklist should be completed quarterly. Each completion takes approximately 20-30 minutes.
Who should use this MHRA GDP Good Distribution Practice Pharmaceutical Warehouse Audit?
This checklist is designed for Distribution Quality Manager professionals in the manufacturing industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.