18 Aug How to have a successful inspection
GCP inspection findings/observations in clinical trials forming the basis for an application for marketing authorizations for new medicinal products or for extending indications to already authorized products have two main implications: Some findings point to GCP non-compliance issues affecting the safety, well-being and the rights of participating subjects; other findings might (also) question the quality and integrity of the data and thus the interpretability of the study results. Failure to the inspection can therefore have seriously negative consequence for the company.
Below list contains some recommendations for a successful inspection. The list should be adjusted according to the specific needs.
Before the inspection:
1. Prepare the management team and all the affected area representatives for the inspection (updated CVs, job description, updated training records)
2. To be familiar with the latest inspection report including the responses. Ensure that all follow up actions are closed and can be explained.
3. Ensure available equipment and facility (book location (nice and clean), parking lot, equipment, printer etc.)
4. Ensure availability of all documentations including access to all IT systems in the scope of the inspection.
5. Train all relevant staff in how to act during the inspection. Follow interview guidance on Dos and Don’ts.
6. Ensure that the interviewees have good communication skills and the ability to provide information in a clear and concise manner.
7. Ensure that all roles and responsibilities are established for the inspection, e.g.:
– who welcome the inspector(s) and accompany the inspector(s) during the day – who should be the persons to be interviewed for each area – who takes the minutes – who should be in the boiler room.
Note: during lunch with the inspector, conversation should not be related to the inspection.
8. If outsourcing, ensure to have all documentations in place incl. contracts, agreements, documentation of key trial decisions. Ensure oversight.
9. Perform pre-inspection/mock inspection as applicable.
During the inspection:
11. Ensure effective internal communication and flow between inspection room, boiler room and the rest of the company/site.
12. Ensure that all requested documents are provided timely. The documents should be qc’ed before providing them to the inspector. A list of all requested documents should be made.
13. Ensure all staff in the scope of the inspection are available.
14. A short wrap up is made every day. The programme for the next day should be agreed upon.
15. Ensure that all findings/observations are understood correctly.
After the inspection:
16. Ensure that any findings/observations are followed up and documented timely according to agreements.
Last but not least, ensure continuous compliance and ongoing maintenance of the trial documents and training records. Be prepared for the next inspection.
PharmaGCP specializes in GCP mock inspections, inspection support, GCP/GVP audits and GCP training. Our specialists have many years’ experience in clinical quality area such as GCP inspector, auditor, clinical quality assurance manager.