GMP Audit

It is important to audit your GMPs properly & efficiently. The following is a quick list of things to do as an auditor. Using this list will help you to make sure that you are on track as you plan and conduct GMP audits

  • Maintain and Use a Written SOP for GMP Auditing
    Establishing a written audit procedure will help to ensure that all audits are conducted in a consistent manner, and that they meet the minimum requirements
  • Assure Confidentiality of Outcomes
    Assuring the confidentiality of the outcomes of the audit and audit reports is extremely important as an auditor. make a good relationship with audit tee. Tell them that you are no way trying to embarrass them and your gesture is not to find their fault.
  • Use Checklist as needed
    Prepare a checklist to audit your organization or alternatively you can use our ‘GMP AUDIT CHECKLIST
  • Make Sure That All Auditors Have Proper Qualifications
    Organization should ensure proper training of its internal auditors & employees. GMP regulations require that employees be properly qualified (through proper training, education, and experience, or a combination thereof) to do their jobs. Relevant training record should be maintained.
  • Address Scheduling Issues
    You should make sure that you do a GMP audit at least once a year. Also, you will have to decide whether to do an announced or an unannounced audit.
  • Eliminate Any Conflicts of Interest
    Audit should be in-biased and impartiality of audit should be ensured. Integrity is one of the most important characteristics of a good auditor, and maintaining integrity necessitates eliminating any conflicts of interest you may have
  • Assume a cooperative and Non- Confrontational Manners while auditing.
    The role of an internal GMP auditor is to assist the company by ensuring that all proper quality and GMP specifications are being properly met. Therefore, work to establish a good working relationship with your audit tees. You really should be working with your auditees to protect your customers, to make sure that everyone gets to keep their job, and that the company remains profitable and respected
  • Make sure that your audit repport is completed in timely manner
    Audit report should be prepared immediately after completion of audit. Also, it is important to get the feedback to the people who are affected by the findings as quickly as possible.
  • The Audit Report should be Fair, Balanced, and transparent
    The purpose of an audit is to make your company better at what it does, not to offend fellow co-workers. While sometimes it may be impossible to adequately do the job of an auditor and not offend anyone, you should certainly try to minimize negative feelings and confrontations without compromising the integrity of your work
  • Plan Corrective Action and re-audit if necessary
    The last step of an audit is to participate in the planning of corrective action, the time frame in which it will occur, and to schedule a re-audit of deficient areas. This will ensure that improvement results from the findings of the audit
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