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.