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WHO GMP audit checklist

WHO GMP audit checklist

This checklist is an essential tool for evaluating compliance with global manufacturing standards. Use it to guide inspections and standardize findings.

Use this template
or download pdf
WHO GMP audit checklist

This checklist is an essential tool for evaluating compliance with global manufacturing standards. Use it to guide inspections and standardize findings.

Use this template
or download pdf

About the WHO GMP audit checklist

By meeting WHO GMP standards, pharmaceutical manufacturers can establish a robust quality management system. This WHO GMP audit checklist simplifies the process by giving you a structured tool to assess your organization’s adherence to these globally recognized guidelines. From personnel training to equipment maintenance, it helps you streamline inspections, document findings, and standardize processes.

Key elements of a WHO GMP audit checklist

A WHO GMP audit checklist is your guide to ensuring compliance and maintaining the highest standards of quality. Here’s how the template is structured:

  1. Organization and personnel: This section evaluates whether roles, responsibilities, and reporting structures are clearly defined. It also checks for adequate training policies and records so that every team member knows their job and adheres to GMP standards.
  2. Premises and equipment: This focuses on the workspace’s suitability for GMP operations. From layout to maintenance schedules, it ensures your environment minimizes risks like cross-contamination and supports proper equipment calibration and upkeep.
  3. Documentation controls: Next, you’ll review your procedures for document creation, approval, and retention. Accurate records provide evidence of compliance and allow for seamless audits.
  4. Production and in-process controls: This captures detailed steps in production, from handling materials to labeling and testing. It ensures consistent quality and addresses how deviations or recalls are managed effectively.
  5. Quality assurance and control: A robust quality assurance system ties everything together, ensuring your products meet both company and regulatory expectations. This section highlights sampling, testing, and corrective actions for continuous improvement.

Why you should use a WHO GMP audit checklist

A WHO GMP audit checklist is a practical tool that simplifies compliance and ensures thorough audits. By using a structured template, you can streamline inspections, organize findings, and identify improvement areas with ease. This saves you time while reducing the risk of overlooking critical details.

Consistency is key in audits, and a well-designed checklist ensures every inspection follows the same standards. It’s especially useful for teams, as it aligns everyone on expectations and procedures, creating a unified approach to GMP compliance.

With all required elements already outlined, you don’t need to start from scratch. Instead, focus on improving operations and addressing issues highlighted during the process. A WHO GMP audit checklist makes compliance more manageable and actionable, empowering you to maintain quality at every step.

Download Lumiform’s WHO GMP audit checklist today

Boost efficiency and accuracy using this professional checklist. With essential sections included, it streamlines inspections and helps you document findings effortlessly. The template guides you through every step of the process, so you can focus on maintaining top-notch quality standards.

Categories

  • Risk management and compliance templates
  • Health care templates
  • Templates for manufacturing processes
Preview of the template
Page 1
Organization and Personnel
Does the organization have an organizational chart defining responsibilities, reporting relationships, and accountability?
Are there written job descriptions for all positions that define the duties, responsibilities, and qualifications?
Is there an adequate number of qualified personnel to carry out all the tasks to the required standards?
Are there policies and procedures in place for training of personnel, including training on GMP requirements?
Are all personnel, including temporary, part-time, and contract personnel, provided with initial and continuing training relevant to their job duties and responsibilities?
Are training records maintained for all personnel?
Premises and Equipment
Are the premises of suitable size, construction, and location to facilitate cleaning, maintenance, and operations as per GMP requirements?
Are the premises designed to minimize the risk of errors and permit effective cleaning and maintenance to avoid cross-contamination, build-up of dust or dirt, and any adverse effect on the quality of products?
Are there written cleaning and maintenance schedules for equipment and premises?
Is there a system in place for the calibration, qualification, and maintenance of equipment?
Are appropriate records maintained for the calibration, qualification, and maintenance of equipment?
Documentation
Are there written procedures describing the various operations carried out in the manufacturing facility?
Are all documents reviewed and approved by authorized personnel before issue?
Are all changes to documents reviewed and approved by authorized personnel?
Are there specific written procedures describing the system for the control of documentation, including the retention of records?
Are all records legible and indelible, and retained for the required time period?
Production and In-Process Controls
Are there written procedures for the production of each product, describing all the steps in the process?
Are there written procedures describing the in-process controls to be carried out during production and the methods for sampling and testing?
Are there written procedures for the handling of in-process and finished products, including packaging and labeling?
Are there written procedures for the handling of returned, recalled, or rejected products?
Are all production and control records reviewed and signed by the responsible person(s) before a batch is released?
Quality Assurance and Quality Control
Is there a comprehensive quality assurance system covering all aspects of production and control?
Are there written procedures describing the quality control system, including sampling, testing, and release of products?
Are there written procedures for the handling of complaints and recalls?
Are there written procedures for the self-inspection of the quality system, including the determination of corrective and preventive actions?
Are all quality control records reviewed and signed by the responsible person(s) before a batch is released?

Frequently asked questions

What are some common mistakes to avoid during a WHO GMP audit?

One frequent mistake is inconsistent documentation. Records should be complete, legible, and up to date. Another issue is inadequate training of personnel, which can lead to errors during operations. Failing to maintain clean and organized premises, neglecting equipment calibration, and overlooking routine self-inspections are other common pitfalls.

What should I do if my audit identifies significant non-compliance issues?

Conduct a root cause analysis to understand the underlying problems. You can then develop a detailed corrective and preventive action (CAPA) plan outlining specific steps and timelines to address the issues. Communicate openly with regulatory bodies if needed and prioritize actions based on risk.

Are there any industry-specific considerations for implementing WHO GMP guidelines?

Yes, each industry has unique requirements. For example, pharmaceutical manufacturers must emphasize cross-contamination prevention, while food safety industries may focus on allergen controls. In sectors like cosmetics, product labeling and ingredient traceability are critical.

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.