Although FDA inspections of clinical sites are not an indictment of something being wrong with a clinical site, it can nevertheless still be a scary experience, especially if you are not properly prepared.

An FDA inspection is basically a quality assurance process that is used to confirm clinical data management/integrity and regulatory compliance.  Here we show you how to make it a piece of cake for your site and your nerves.

Kinds of inspections

-The most common FDA inspection is the ‘routine inspection’, prompted by a New Drug Application (NDA) submission.  The typical candidates for a routine inspection are clinical sites that enroll the majority of patients in the NDA’s critical clinical  trials.

-‘For Cause inspections’ are not common, and are prompted when the FDA receives a report of, or becomes aware of, suspicious behavior.  Here are some reasons that may bring about such an audit:

_ The carrying out of many clinical trials

_ The carrying out of clinical studies outside of your specialization field

_ The reporting of much better effectiveness, less unfavorable effects, or different laboratory results from other sites studying the same drug

_ Having noticeable access to a large number of patients with a specific disease state for the setting

_ Complaints from a patient or sponsor in regards to regulations, protocol, or human rights violations

-Customer complaints that may trigger a product recall

How it all starts

It all starts with a phone call.  The FDA will call to program an inspection at a time that is agreed between both parties and that does not interrupt the site’s activity.  Nevertheless, they will only give you between 5 to 14 days notice, and will spend around 2 to 3 days on site.

You are entitled to ask what study they are going to inspect and who should be available during the visit, and contact the study sponsor immediately, because this sponsor can give you good suggestions and they are not directly notified by the FDA about clinical site inspections.

Before the inspection, gather these documents for the study in question:

-Protocol

-Investigator’s brochure and IND Safety Reports

-Form FDA 1572 with accompanying CVs

-IRB correspondence, including approval documentation and final report to IRB and Sponsor

-IRB-approved Informed Consent form

-IRB-approved advertising

-Correspondence related to the study, excluding investigator agreement and financial information

-Monitor sign-in log

-Laboratory certification documents

-Drug accountability records

-Each subject’s signed informed consent

-Assess support areas, like pharmacy or lab, to make sure they are properly prepared.  The FDA may tour the facility

Be ready to answer these questions:

-    Where was the study done?

-    What special equipment was used?

-    Who assisted in doing the study?

-    What were each person’s specific responsibilities?

-    Describe the sponsor’s monitoring procedures and your interaction with the monitor.

-    How did you account for the drug received, distributed to, or returned from subjects?  Were all drugs returned to the sponsor?

Train your personnel to relate to the FDA.  You must show you are a professional and should answer questions in a direct way, without giving information they haven’t requested.

When the inspector arrives

First, check his ID, because you don’t want an unauthorized person checking your files.  The inspector will fill a Notice of Inspection (FDA Form 482) and will hand it to you.

1.The inspector will begin by determining the nature of the investigator’s conduct of the study.  He may want to tour the facilities and talk to everyone who took part in the study.

His intention is to establish the level of delegation of the investigator’s authority, where specific procedures were performed, where and how the data was gathered, and where the drug was accounted for and stored.

These things are normally checked:

-Communication capability with the IRB, including the initial submission document, adverse event reporting, and progress reports

-Totality of accountability documentation for the receipt, storage, administration, and return of test article (drug, device, etc.)

-Compliance with the study protocol and documentation that each deviation/amendment received the approval of the IRB and the sponsor

-Aptness of the informed consent process

-Timely and full reporting of adverse events to the IRB and sponsor

-Compliance with the record retention requirements and that the investigator had instant access to the study records during the trial

-Ample monitoring of the site and communication with the sponsor

2.The inspector will move on to audit the data.  He will compare the data submitted to the FDA with the medical charts and source documents that support it.

He will review data from before and after the subject’s participation to make sure the subject had the medical condition under treatment and that excluded medications were not given to him or her during the study period.

3.After finishing the audit, the inspector will meet with the investigator to talk about the results.  Any inconsistencies will be registered on FDA Form 483, of which you will receive a copy.

4.The inspector will write an Establishment Inspection Report (EIR) that will be sent to the FDA for evaluation.  You will receive a letter after this evaluation is finished.

This letter may show one of three scenarios:

-It may simply recognize that the inspection was done and that nothing significant was found.

-It may list deficiencies found during the inspection, but may point out that no response is necessary.  Nevertheless, it is important that the site acts on these deficiencies in view of future inspections.

-It may point out serious negative discoveries.  The site and the data are at risk here, and you must answer immediately to clarify what steps you will take to solve the situation.

Get the help of your sponsor, because the pharmaceutical company has lots to lose too, and contact your pharmaceutical consultant for guidance and support.

If you do not respond correctly, you may be banned from performing other studies; your study data, or even the whole marketing application, can be rejected; and you may even face criminal charges.

The EIR is available, upon request, to the site, sponsor, and general public, after 4 to 6 months through the Freedom of Information Act.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

This is the drug manufacturer’s nightmare: the phone rings and an FDA official announces an upcoming inspection.  Even though they are clearly necessary, FDA inspections are a weight on pharmaceutical companies’ shoulders.  Without these inspections, pharma companies cannot keep the FDA’s approval to sell their products.

It is the FDA’s duty to call in advance to announce an inspection, its purpose, duration, and number of people involved.  On inspection day, the FDA official will ask to see the top management person on site, and he will show his credentials and an FDA ‘Notice of Inspection’ to that person.  Afterwards, a thorough inspection of the facilities will begin, while one or more key employees tag along.  After a few days, the FDA will send an ‘Inspectional Observations form’ to the leadership team informing them about any unacceptable conditions they have found in regards to products, processes, or other violations to the FD&C Act.

The results of such an inspection can range from no needed actions to a complete closing of the facilities and administrative, civil, or criminal actions against the company.  Normally, the FDA will recommend actions to improve operations in line with the FD&C Act.

Given the serious nature of this process, it is necessary to plan ahead and be ready for the eventual call.  Here are 5 tips to welcome the FDA with a smile on your face:

1.    Implement regular internal FD&C Act compliance training
The best way to ensure a successful FDA inspection is to ensure the facility complies with FDA regulations.  Every employee must be aware of the products and processes’ FDA standards for the area he or she tends to.  Employees have to be trained to stay calm, be respectful, and follow the FDA official’s requests, as well as to know their rights about what they have, or not have, to say or show the FDA.

2.    Identify and work on weaknesses
Smart professionals work on identifying the weaknesses that could attract the FDA’s attention before this happens.  Some examples are potential contamination, under maintenance, and unclean areas.

3. Select key people to accompany the FDA official
Train two or more employees who supervise the major processes to follow the FDA official.  Teach them how to treat and interact with this person.

4.    Write an operations manual
Operations manuals should be the main reference in the facility.  Employees must have continuous access to them in order to check actions and steps to maintain FDA compliance at all times within their areas.  This provides education and encouragement to go through any inspection with confidence.

5.    Make regular FDA compliance checks
Don’t wait until the FDA is there to identify the problem areas, identify them yourself and work with your personnel to fix them.  This will give your people confidence because they know what they are dealing with and they know how to solve it.

FDA inspections are normally not happily welcomed because they require a lot of additional resources and energy, however, every pharmaceutical consultant will tell you that being prepared is not only the best way to pass the inspection, but also to get your business under control and avoid worrying about what is out of your hands.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

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Would your pharmaceutical company know what to do if the FDA suddenly showed up at your door?  Would your senior management be ready, would your staging room be ready?  Would your receptionist be ready to handle the protocol that takes place during an FDA audit?   Does your pharmaceutical company have the correct documents in place needed for an FDA audit?  An FDA citation can set your company back months, even years, not to mention the thousands of dollars in fines your company is likely to face.  If you’re not sure that your company is FDA compliant, it would be an excellent idea to hire an outside pharmaceutical consulting firm that specializes in mock FDA audits and regulatory inspection readiness.

This outside pharmaceutical consulting firm will help you understand why you might be getting audited, and prepare your company to pass any surprise or scheduled regulatory inspections, that might be in your company’s near future.  They will help you understand the purpose for the inspection, and help you make ready all the necessary regulatory filing that may be involved.  They will inspect all the logistics in and around your company and will work to prepare your site according to FDA standards.  They will help to prepare your computer and automated systems so that they will be compliant for any regulatory review.

Another important pre-testing measure that an outside pharmaceutical consulting firm can offer is a quality systems gap assessment.  These tests are vital for any inspection training that your company is looking for to prepare for your FDA audit.  They will test all procedures and analytical methods to see that they are up to par and can be validated.  This includes methods for testing, sampling, and data evaluation.  They will make sure that all your equipment used for testing and sampling is properly calibrated, and well maintained.  Environmental conditions such as humidity, oxygen, temperature, even electromagnetic interference will all be monitored and controlled.  They will also work to make sure you have the specific documents in place, such as policies and a specific quality plan.

A pharmaceutical consultancy firm will help provide your company with the tools and expertise needed to prepare your organization for any regulatory inspection, surprise or mandated.  They will utilize the inspection results to give your company a competitive advantage, while teaching your company how to stay ready long after the initial mock testing is completed.  Creating an accurate and thorough system is key to develop an effective regulatory training system, which will help your pharmaceutical company to pass any FDA inspection every time.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggrp.com as the original source.

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