Top 10 Tips for FDA Inspection Preparation : Pharmaguideline

Online GMP Courses with Certificate


Top 10 Tips for FDA Inspection Preparation

Regulatory audits help to improve the quality of pharmaceutical products. Here are some important tips to prepare for regulatory audits.
FDA audits are very important and regular part of the pharmaceutical industry. Regulatory audits ensure the quality and safety of pharmaceutical products. But it is not easy to pass FDA audits and it needs proper planning. Here are some useful tips that will help pharmaceutical companies to pass the FDA audits successfully.

1. Understand the FDA Regulations

All staff members and workers must understand current FDA regulations and guidelines. New updates must be communicated to the team and everyone should be up to date.

2. Review the SOPs

Review SOPs of all departments before the audit and make necessary changes that are required according to the recent regulatory updates. FDA inspectors will check the SOPs of all departments to confirm that firm’s standard operations meet the regulatory standards and guidelines. Always remember “Do what is written and write what you are doing”.

3. Conduct Internal Audits

Internal audits help to familiarize the team with the audit process. Internal audits must be conducted at a specific interval. It will help the firm to find the deficiencies in the process and documents before the FDA audit. Internal auditors should be qualified and experienced in pharmaceutical manufacturing and quality.

4. Training of Personnel

All the employees including staff and workers must be trained in the job they are doing. Proper training sessions must be conducted time to time. Training record is the mandatory requirement of the FDA inspections. Training record must be maintained with the attendance of the trainees and FDA inspectors always review these records.

5. Facility Preparation

Prepare a checklist for cleanliness of the facility and equipment in production area. Check the cleaning schedule and cleaning record. Temperature and humidity are also an important aspect during FDA audit. These parameters should be properly maintained in facility and record must be maintained. Check if all hygrometers and thermometers are walking properly.

6. Previous Observations

Review the previous audit findings and implement corrective and preventive actions given during previous audits. FDA inspectors always check the previous audit findings and their implementation. If firm fails to produce the implementation, then they definitely issue a form 483.

7. Documents and Records

Documents are the most critical part of a pharmaceutical manufacturing company. Documents like protocols, batch records, change controls, specifications, test procedures should be maintained. Old and obsolete documents should be maintained in records. Documents should be readily available on requirement. Company must follow the data integrity rules in documentation. ALCOA+ principles must be implemented properly in all departments of the facility.

8. Staff Readiness

It is required to get mentally prepared for audit before it actually conducted by FDA. Create a team with their dedicated work during the audit. I will help to manage the work with the responsibility and it will get finished before the time.

9. Good Communication

Communicate openly with the FDA auditors, speak honestly and tell the actual condition during the audit. Answer the questions promptly asked by the FDA inspectors otherwise it could be suspicious for the auditors.

10. After Audit Follow-up

Implement the audit findings and corrective and preventive actions properly. Learn from audit findings and improve the system and documentation continuously.

Preparation for the FDA audit is the key to success and also helps to improve the quality of the product. All the above points will definitely help to prepare better for an FDA audit. If you have any problem or query regarding FDA audits, feel free to ask us.
Get documents for Audit preparation in MS-Word FormatView List

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question

No comments:

Post a Comment

Please don't spam. Comments having links would not be published.

Popular Categories

QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration Warning Letters Education B.Pharmacy
Online Courses

Follow Pharmaguideline



Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...



Recent Posts