Top 10 Tips for a FDA Inspection

Following tips can be useful for a Organization during regulatory Audit

1. Arrange the Required documents as per the Audit Agenda in the near by location of auditor room before one day to avoid delay in showing the required document to the auditor and arrange all the documents with proper labeling and keep all the documents in lock & key. The audit compliance person of the organization along with quality Assurance should lead the team and should communicate with all departments before start of audit or during audit.

2. Retrieve all the required documents from document cell or from the respective places and follow the document retrieval procedure and after completion of audit submit the required documents to Quality Assurance or keep the documents in their respective places.

3. Review all the documents which are requested by the auditor before sending it to auditor and the documents required to be checked for any missing entry or sign or date, availability of all the pages, completeness etc.

4. The Subject matter Expert (SME) of the particular department should explain about the system or procedure which are asked by the auditor or the auditor may ask question to the person who has perform the activity or the doer so be ready for that.

5. If a person is not able to understand the language of auditor then the other persons who are guided the auditor or who are present along with auditor shall translate the same in to the regional language and help him or her to understand the question. If required translate the same to English

6. Answer all questions honestly which are asked by the auditor and never give false data and always tell the truth. If you don’t know the answer then you tell I don’t know or let me check and call the Subject matter Expert to answer the query and don’t guess if you are not sure.

7. Listen the question carefully and answer only what asked and clarify what you don’t understand before answering the question during audit.

8. Auditor may read your body language so be aware of your body language so don’t stand around the auditor in worried face which may make people nervous and may alert auditor that something may wrong.

9. Don’t argue with the auditor when answering a question asked and don’t challenge the auditor and if something misunderstood then explain it in professional manner.

10. Each person should know the system and the procedure of their respective areas where they are working and every body should understand their job role and responsibility.

11. The team along with the auditor shall note down the observation findings during the audit and shall compile the observation or shall raise the necessary deviation or CAPA on the same day which are observed by the auditor.

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