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GMP warehouse audit checklist template

GMP warehouse audit checklist template

Use this comprehensive GMP checklist to cover critical areas, from inventory control to sanitation, and improve compliance with industry standards.

Use this template
or download pdf
GMP warehouse audit checklist template

Use this comprehensive GMP checklist to cover critical areas, from inventory control to sanitation, and improve compliance with industry standards.

Use this template
or download pdf

About the GMP warehouse audit checklist template

Conducting a GMP warehouse audit is about maintaining rigorous standards for quality, safety, and efficiency in your facility. Whether you manage operations in pharmaceuticals, food production, or logistics, this checklist helps you standardize inspections, ensure regulatory compliance, and organize findings. With this GMP checklist, you’ll guide your team through critical checks like material handling, storage conditions, and inventory control.

Key elements of a GMP warehouse audit checklist

A GMP warehouse audit checklist is your roadmap to maintaining compliance and improving operational efficiency. Here are the essential elements that make up an effective checklist:

  1. Receiving area inspections: Focus on cleanliness, organization, and inspection processes. Evaluate how materials are received, quarantined, and checked for damage or discrepancies. Proper documentation at this stage leads to accountability and traceability.
  2. Material handling protocols: This section assesses how materials are stored, labeled, and protected from contamination. Include details on storage conditions like temperature, humidity, and designated zones to prevent mix-ups.
  3. Inventory control measures: Monitor stock accuracy, expiration tracking, and stock rotation practices like FEFO or FIFO. Accurate records and clear labeling help you avoid costly errors.
  4. Cleaning and sanitation standards: Review schedules, tools, and pest control methods. This keeps your facility safe, compliant, and well-maintained for high-quality operations.
  5. Documentation and training: Check for up-to-date SOPs, staff training records, and equipment logs. Well-documented procedures enhance team efficiency and reduce non-compliance risks.

Customizing the GMP warehouse audit checklist

Every warehouse has unique operations, and you can edit the GMP warehouse to reflect those.

First, adjust sections to match specific regulatory requirements. Industries often follow different standards, from FDA regulations in pharmaceuticals to ISO requirements in manufacturing. You can modify the checklist to include compliance checks for guidelines like maintaining cold chain integrity for medical supplies or tracking allergen segregation in food warehouses.

It’s also possible to modify question phrasing to align with your processes. For example, instead of asking, “Are storage conditions monitored?” you could specify, “Are daily temperature logs for freezer units recorded and verified?”

Feel free to simplify or expand the checklist based on team responsibilities. If your team consists of multiple roles, break the checklist into sections for different departments, such as receiving, storage, and sanitation. Alternatively, for smaller teams, condense it to focus on critical compliance areas only.

Download Lumiform’s GMP warehouse audit checklist today

Streamline your audits with a template designed to fit your needs. With this checklist, you can cover key areas like material handling, storage conditions, and documentation procedures in one comprehensive tool. Its flexible structure adapts to your workflow so you can focus on what matters—ensuring compliance and quality every step of the way.

Related categories

  • Quality management templates
  • Risk management and compliance templates
  • Logistics and transportation templates
  • Warehouse templates
  • Inventory management templates
  • Quality assurance templates
Preview of the template
Page 1
General Information
Name of Facility
geolocation!!!
Date of Audit
Auditor Name
Receiving Area
Is the receiving area clean, uncluttered and well maintained?
Are materials received inspected for damage, identity and quantity?
Are materials quarantined until released for use?
Are appropriate storage conditions maintained for received materials?
Are temperature and humidity monitoring records maintained?
Material Handling
Are materials handled in a manner to prevent mix-ups and contamination?
Are materials stored off the floor and with sufficient clearance for cleaning?
Are all containers and labels clearly identified?
Are there designated storage areas for different categories of materials?
Are materials stored under appropriate environmental conditions?
Inventory Control
Is there a documented inventory management system?
Are inventory records up-to-date and accurate?
Are all materials labeled with expiration/retest dates?
Is stock rotation (FEFO/FIFO) practiced?
Are expired or rejected materials segregated and clearly identified?
Cleaning and Sanitation
Is there a documented cleaning and sanitation program?
Are cleaning schedules and records maintained?
Are cleaning agents and disinfectants suitable for use in a GMP environment?
Are cleaning tools and equipment maintained in good condition?
Is the warehouse free from evidence of pest infestation?
Documentation and Procedures
Are all warehouse SOPs documented and available to staff?
Are staff trained on relevant SOPs and training records maintained?
Are equipment calibration and maintenance records up-to-date?
Are deviations, investigations and CAPA records maintained?
Is there a system to control access to the warehouse?

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Related resources

Access a complete set of resources aimed at maximizing safety, quality, and operational excellence, including detailed guides, related templates, and real-world use cases.

Topic guides

Read in-depth guides covering key topics related to this article.

Good Manufacturing Practice (GMP): Your guide for safety and complianceGMP in pharmaceuticals: Ensuring quality and safetyAdvanced Product Quality Planning (APQP): A detailed guide
See all topic guides

Template collections

See comprehensive collections of best practice templates related to this topic.

13 free GMP audit checklists to improve compliance3 free must-have pharma audit checklistsTop 23 internal audit checklist to improve your process
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Use cases

Check out how the Lumiform software can be utilized for related use cases.

GMP softwareCompliance audit softwareQuality Control Software for Manufacturing
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Other resources

Explore all the additional resources we offer to assist you in mastering this topic.

10 principles of operational excellenceHow to evaluate compliance measures4 ways process improvement increases profitsHow inventory management software can help you build an inventory management system

Frequently asked questions

What are some common mistakes during a GMP warehouse audit?

One common mistake is neglecting to update SOPs regularly, leaving teams to follow outdated procedures. Another is overlooking small but critical details, like proper labeling or accurate temperature logs, which can lead to significant compliance issues. Failing to engage staff in regular training also weakens audit readiness.

How can I prepare for a surprise regulatory inspection?

Keep your warehouse audit-ready by maintaining consistent records and conducting internal checks regularly. Focus on high-risk areas such as material handling and environmental monitoring. Assign a team to routinely review compliance, and consider performing mock inspections to identify gaps before regulators do.

What steps should be taken if non-compliance is found during an audit?

Start by documenting the issue thoroughly, including root causes and impacted areas. Develop a corrective action plan (CAP) with specific deadlines and assign responsibilities to the right team members. Communicate the findings clearly to all stakeholders, then conduct a follow-up review.


This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.
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