Auditing Contractors and Suppliers: A Guide for Drugmakers
The most critical aspects of your drug manufacturing operation depend on having the right contractors and suppliers. But once you have chosen the best, how do you make sure they are upholding the standards you set? A program of regular audits is essential.
Auditing Contractors and Suppliers is a comprehensive guide that will help you build a GMP auditing program to oversee the quality of incoming goods and services. You’ll be able to determine what type of audit to use in different situations, when and how often audits should be performed, who should be involved in the actual audit, how the process should be documented and the format for reporting results. You’ll find the tools you need to set audit priorities and ensure your products meet regulatory requirements and your own high-quality standards.
International auditor and GMP expert Stephanie Blum shares essential details about regulatory expectations, audit priorities, auditor interactions and audit documentation. She explains the steps your team should take when following up on audit recommendations and how to use audit checklists to encourage a smooth, successful process. Through her guidance, you’ll have the insights you need to build productive audit plans and get results that will take your product safely to consumers.
- GMP audit basics
- Understanding different types of audits
- The five primary principles of GMP audits
- Regulatory requirements
- Setting audit priorities and procedures
- Determining what systems should be audited
- Planning the timing and frequency of audits
- Conducting risk-based audit planning
- Documenting and recording an audit
- Collecting audit information and audit findings
- Documenting and formulating audit details and findings
- Using audit checklists
- Following up on audit recommendations
- Understanding key aspects of the final wrap-up meeting
- Developing a plan for carrying out recommendations
This report includes a full-scale guide on moving through the audit process and ensuring your contractors and suppliers remain compliant. Find the tools you need to build an effective audit program — and ensure your products meet quality and regulatory requirements.
About the Author
Stephanie Blum is the owner and CEO of cirQum consultancy in Frankfurt, Germany. She works as an auditor, consultant and speaker and she has authored numerous expert publications on the subject.
Who Will Benefit
- Third-party auditing organizations
- Quality management staff
- Regulatory staff
- C-suite executives
- Manufacturing line supervisors
- Lab managers
- Inspections and audit staff
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