Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
1st and 2nd Party Audit Report and Follow-up
Producing an Audit Report: What Happens Next
Once you have planned and performed a first party (internal) or second party (external) audit, it is imperative that you document your findings in a formal audit report. Regulatory inspectors expect a ‘show and tell’ approach and in their eyes, if it’s not documented, it didn’t happen! Our American friends in the FDA (Food and Drug Administration) would say, “if it’s not written down, it’s just a rumour!”
Regulatory Inspector Expectations
All licensed GDP wholesaling operations must be fully accountable and transparent to regulatory inspections, and that means the regulatory inspector needs to see evidence of 1st and 2nd party audits good clear documentation, processes and effective audit schedules and management in place. They would also ask about your staff training schedule and ask the Responsible Person (RP) to evidence that persons performing 1st and 2nd party audits have completed relevant GDP training. (No members of staff should be engaging a role without formal GDP Training ahead of their job engagement.)
An inspector would also be looking out for general maintenance such as cleanliness, waste control, pest control, security systems, and climate temperature control, along with the required documentation.
The structure of your audit report should include:
- Details of the auditor and auditee
- A summary of the audit process
- Area or procedure that was audited
- Findings from the audit
- Final conclusions
- Re-audit schedule
- Distribution list
- Sign off
When writing your audit report, document clearly your findings and link these to the relevant guideline, standard or regulation clauses.
Documenting
If when auditing the storage areas of medicinal products, you find that temperature control monitoring equipment has not been calibrated at defined intervals based on a risk and reliability assessment, this is a non-conformance against EU GDP Guidelines Chapter 3, Section 3.3 and can be documented as such in your audit report.
It is also worth noting that the main purpose of performing audits is to check for compliance. Therefore, it is important to document key areas where operations or procedures were compliant as well as non-compliant in your report. If you find that temperature monitoring equipment has been positioned in accordance with the results of a mapping exercise, this is in conformance with EU GDP Guidelines Chapter 3 Section 3.2.1 and can be documented as such on the audit report.
When writing your audit conclusions, be sure to also include a statement to which the audit criteria have been fulfilled. Advise that only a sample area has been audited, unless a full QMS audit has been completed. You can also add any implications for the next audit within this section.
In the event of nonconformances or deficiencies, it is important that these are investigated and corrected either internally or by the external company.
- The cause of the nonconformance or deficiency should be determined and CAPAs should be raised to correct the nonconformance and prevent the deficiency from reoccurrence in the future.
- There should be a clear timeline for implementation and post implementation effectiveness checks.
- The auditor should follow up on the CAPAs to ensure that they have been implemented and where appropriate conduct a follow up audit to check the effectiveness of the CAPAs.
Further Support and Training
Learn more about audit reports, what they should contain and how to effectively manage post audit follow up by registering for our cost effective ‘GDP Awareness’ training course. The online format of the course enables you to take the course at a time convenient to you and your organisation.
If your organisation could benefit from support with performing audits writing audit reports or post audit remediation work, Paradigm Shift Consulting offer a range of auditing services and can support your organisation every step of the way. Contact us today for a free 5-minute consultation to see how Paradigm Shift can help you ensure compliance within your organisation.
Get in touch with us by using the contact form below, or call us on the number at the top of this website.