How to handle FDA Inspection ?

This article provide information about How to manage regulatory inspections i.e. How to welcome the auditor, How to communicate with auditors, How to answer the questions which will ask by auditors and closing meeting.

Handling of FDA Inspection

During FDA inspections Company personnel should be Prepared, Responsive and Confident.

1. Welcome to the FDA Investigator:

• FDA investigators should be treated like all facility guests.
• They must follow appropriate procedures for signing in on the guest register.
• They must be accompanied by company personnel at all times.
• When the investigator arrives at a company’s facility, the receptionist, or the first person to great the investigator, should ask for the investigator’s name and identification and immediately contact the employee designated to accompany the investigator.
• Designated employee should be a knowledgeable person in the company, such as an individual from operations, regulatory affairs, and the quality department.

2. Identify purpose of FDA Inspection:

The designated employee should check the investigator’s credentials and determine the purpose of the visit.

The FDA investigator will present a “Notice of Inspection” or FDA 482 to officially Document that the inspection is being performed on the specific date.

3. Opening Meeting :

Opening meeting will be done with the auditors and all Respective department Heads or key stake holders of the respective site .

Points will discuss in this meetings are as below :

• Formal Introduction with  available  stake holders in opening meeting.
• Presentations will be presented by site leadership team to the auditor which contains the brief overview of the site e.g. Like about Facility, Utility, Safety, Quality, Policies (Safety/Quality),Employee Strength, Available Dosage Forms. Accreditations till date etc.
• Discussion of audit agenda.
• Either they will start the day with the round or will check the documents or. vice versa. If two or more auditors are there they can split for inspections for different work and specialties.

4. Communication with the Auditor :

Strive for good communication:

FDA’s inspection goal is to assure that GMP’s are being followed and that manufacturers produce products that meet quality, safety and effectiveness standards. In the effort to maintain a good relationship with FDA, company personnel should strive for five basic goals when communicating with an FDA investigator.

Be Prepared:

The best for any company to be prepared for an FDA inspection is to ensure that all the operations of the company are always under control and operating in a state of compliance with the GMP regulations.

Be Responsive:

The investigator is learning about the company’s operations, and he or she must absorb a great deal of information very quickly. Company personnel must be patient with the investigator at all times. Being patient with the investigator will help assure that individuals are being responsive to the needs of the investigator.

Be Direct:

Answer the FDA’s questions directly as possible without providing any additional information. Being direct eliminates misconceptions and misinterpretations about the manufacturing process.

Be Confident and Honest :

Answer the investigator’s questions in detail and honestly to ensure the investigator thoroughly understands the equipment or process. State only the facts, as you know them.

Take Notes:

Taking notes will allow personnel to Maintain a record of all comments and suggestions made by the investigator throughout the inspection.

Make corrections when appropriate:

When an investigator notes a GMP deficiency during the inspection, company personnel should attempt to correct the problem immediately if possible. Company personnel should make the investigator aware of these corrections as it shows an effort by the company to comply with regulations.

5. What are the Areas where FDA Inspector may visit during Inspection :

Warehouse, Production and Quality Control Round,

   Building and Facility, All equipment and instruments of production and Quality Control, Materials, Packaging and Labeling.

6. What are the Documents which may Inspect/Review during Inspection :

Dossier Documents, Procedures for warehouse, Production, Testing and Distribution, Batch Manufacturing and Testing Records , Validation Records, Calibrations and PM Records, QMS Documents (Change Control/Investigation/Deviations/CAPA), Qualification Documents, Rejection Records, Sanitation records etc.

FDA inspector ask documents which are in the preview of cGMP and with Reference of Batch Manufacturing, Testing and Distribution of drug substances and drug products.

7.What is the Procedure During Round If FDA Inspector asks for product Sample ?

During the inspection round. If FDA inspector want to take the sample from the specific lot or batch, upon receipt of FDA form 484 to the manufacturing firm, Inspector is allowed to take the Material and product sample.

8. What FDA Inspectors will not Inspect and will not be ask for review during Inspection :

Monthly/ Yearly Sales Report of the site.

Research Data

Product Pricing Data

Personal Record other than training

9. Close-out meeting:

At the completion of the inspection, the FDA investigator will hold a Close-Out meeting. Company should ensure that all respective department heads or key personnel attend the Close-Out meeting so that qualified personnel can properly respond to 483 observations. The Close-Out meeting provides all parties an opportunity to explain any observations, or correct any misunderstandings.