fda inspections

8/11/2019 FDA Inspections

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Improving Quality and Compliance

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How to Prepare for an FDA Inspection

Audits by third parties dont have to be stressful events. The level of preparation within your organization

will make a significant difference in your level of success. Below are some helpful hints and techniquesthat will enable your organization to perform smoothly during an FDA inspection.

Organizational Culture

Lets start by considering where your organization is now in terms of readiness. Is being audited an

opportunity to tell your story? Is it thought within your organization that all of this quality stuff is in the

way of doing business? It must be understood that the single most important element for a successful

audit outcome is the existing quality culture within your company. Substantial compliance to quality

systems can only be derived from the diligent execution of all requirements defined within the Quality

Management System as a matter of doing business, each and every day. What you are doing in an

audit is communicating and demonstrating how you run your business within the framework of your

Quality Management System. How well you do this makes a difference.

Audit Procedure

In order to execute a third party audit, you need to first prepare by defining how you want the audit to be

executed within a Third Party Audit Procedure.

The procedure should, at a minimum, define:

1. How to Receive Inspectors

Verify Credentials

Communications to Executive Staff & Employees

Opening Presentation

2. Duties of key individuals

Receptionist

Audit Support Team Members

3. Audit Room & Control Room Set-up

4. Conducting Tours


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3. Subject Matter Experts - Individuals who are focused on specific processes each and every

day. They are specially trained and prepared for audit situations.

4. Control Room Staff

5. Employees

6. Management Team

Employee preparation is essential. Each and every employee does not need to know the details of the

execution and goings on within the audit, but they do have to be prepared and know they play a role

within the audit. Employees should be prepared to answer key questions such as:

1. What is the Quality Policy?

Ensure each employee understands and can speak to what the policy means to them

Use the Quality Policy Training

2. How do you know whats required of you in your job?

As defined within my job description,

As I have been trained to do

By following approved procedures and work Instructions

Know how to access procedures and work instructions

Bring up errors in procedures and instructions now

3. Is your training current?

Ensure your training in TRS and LMS is current

If there are gaps, complete the training now and maintain it!

4. What if I dont know the answer?

I am not surebut I will get the information for you.


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These basic steps of preparation should be defined, implemented and practiced for successful execution

during an audit. Practice makes perfect!

Inspection Procedure

Prior to inspection day, it is important to understand what the third party can and will look at while on site.

The FDA, in particular, is somewhat prescriptive in what information they can and cannot access. The

FDA has authority to inspect all equipment, materials, products, labeling, and surrounding documentation

including but not limited to SOPs, clinical study and quality systems documentation. They do not have

the authority to inspect certain documentation such as personnel data, financial statements, R&D

records, audits and management reviews.

Understanding how the auditor will determine the compliance and effectiveness of your Quality System

can also help you prepare your staff in advance. The Auditor will plan to examine the system from either

the bottom up or from the top down as depicted below:

The QSIT inspection approach is a "top-down" approach where the auditor will be looking at the firm's

"systems" for addressing quality before they actually look at specific quality problems. In the "top-down"

approach, they will "touch bottom" in each of the subsystems by sampling records, rather than working

their way from records review backwards towards procedures.

What will they be looking for?


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Verification that your CAPA system procedures have been defined and documented.

To determine if appropriate nonconformance sources of product and quality problems have been

identified.

To determine if these sources of product and quality information are trended and if any

unfavorable trends have been identified.

To challenge the quality data information system and verify that the data received by the CAPA

system are complete, accurate and timely.

Verification that appropriate statistical methods are employed to detect recurring quality

problems.

Timelines for approval and execution follow a logical sequence.

To determine if failure investigation procedures are followed.

To determine if appropriate actions have been taken for significant product and quality problems

identified from nonconformance data sources.

To determine if corrective and preventive actions were effective and verified or validated prior to

implementation.

Verification that corrective and preventive actions for product and quality problems were

implemented and documented.

To determine if information regarding nonconforming product and quality problems and corrective

and preventive actions has been properly disseminated, including to Management Review.

Objective evidence that Executive Management is engaged.

Conclusion

A successful outcome from a third party audit is dependent upon many factors and preparation is key.

While the material offered in this article will help provide insight into third party audits, it is not all

encompassing. If you would like additional information or help in specific areas of preparation or

remediation, please do not hesitate to contact us.

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