Vendor audit is an evaluation of a vendor manufacturing process, practices, documentations and quality compliance by offline (physical) or online (desktop).
Conducting a vendor audit in the pharmaceutical industry is an essential process to ensure that suppliers and vendors meet the required standards and regulations.
Vendor Audit Process
Define Audit Scope
Determine the scope and objectives of the audit. Identify the vendors or suppliers to be audited and establish the criteria against which their performance will be evaluated. This may include quality management systems, regulatory compliance, product quality, documentation, and other relevant factors.
Pre-Audit Preparation
Gather relevant information about the vendor and their products or services. Review any previous audits or quality assessments. Develop an audit checklist or questionnaire that aligns with your audit objectives.
Plan the Audit
Schedule the audit with the vendor and inform them about the purpose, scope, and duration of the audit. Notify the vendor in advance of any specific documents or records you may require during the audit.
Conduct On-Site Audit
Conduct the vendor audit at the vendor’s facility. Start with an opening meeting to introduce the audit team, explain the audit process, and clarify the audit objectives. During the audit, review documentation, observe processes, and interview relevant personnel. Use the audit checklist or questionnaire to systematically assess compliance and performance.
Document Findings
Record your observations and findings during the audit. Ensure that any deviations or non-compliance with regulations or standards are clearly documented. Collect supporting evidence and identify areas of improvement or potential risks.
Communicate Audit Findings
Hold a closing meeting with the vendor to discuss the audit findings. Provide a detailed report that includes both positive aspects and areas requiring corrective actions.
Follow-up and Corrective Actions
Monitor the vendor’s response to the audit findings and ensure that corrective actions are implemented within an agreed-upon timeframe.
Review and Approve Vendor
Once the vendor has addressed the audit findings and implemented corrective actions, review their response to ensure compliance. Determine whether the vendor meets the required standards and regulations. If satisfactory, approve the vendor for continued collaboration. Otherwise, outline any remaining concerns and request further actions if necessary.
Ongoing Vendor Monitoring
Maintain ongoing monitoring of approved vendors through periodic audits or quality assessments. Establish a system for evaluating and reevaluating vendors based on their performance, regulatory compliance, and quality of products or services.
Remember that the specific audit process may vary depending on the company’s policies and applicable regulations. It’s important to consult internal quality management procedures, industry guidelines, and regulatory requirements while conducting a vendor audit in the pharmaceutical industry.