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:
- 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.
- 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.
- 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.
- 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.
- 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.