Every pharmaceutical professional is immediately awake when hearing about the FDA Audit, and different types of
thoughts came into his/ her mind. Is he/she ready for this inspection? Is my
team ready to face the audit? What document is ready and what is under
preparation? Who will be the auditor and what is his background? In which field
the auditor is expertise? How many observations were previously given by this
auditor? Who is going to lead the audit at my site? These are the basic
thoughts that came to mind and everybody at the respective site engaged in the
readiness of the audit to make it successful.
But basic question is that, why this type of thought
process came in mind after announcement of FDA Audit. It means you are not
ready right now to face the FDA. But FDA not wait for your readiness, you have
to always prepare to face the FDA at any time in any circumstance.
What is FDA and why they do Audit: The
U.S. Food and Drug Administration (FDA) is a federal agency under the United
States Department of Health and Human Services. It is responsible for
protecting and promoting public health by regulating various products that
impact the health and safety of the American public. The FDA's main focus is to
ensure the safety, efficacy, and quality of food, drugs, medical devices,
cosmetics, and other products that are consumed or used by people.
On the first day of job, FDA inspectors take an oath of
allegiance to the U.S. government and swear to uphold the Federal Food, Drug
and Cosmetics Act. Right from the beginning, they are officers of the
government, just like an FBI agent or a U.S. marshal, and they take their job
just as seriously. An inspector’s goal is to find violations, and they are good
at it. They are highly educated and trained not only in the views of good
manufacturing practice but also in techniques for eliciting information from
individuals and their advancement within the agency is tied to their results.
The FDA inspectors are very serious about their job and
doing audit to make surety about the drug and drug product that is using by
U.S. public is manufactured under CGMP regulation and meeting the USA quality standard.
The drug and drug product that is consumed by U.S. people is without harm for
their people.
Roadmap to FDA Audit Readiness: To
complete the audit successfully without any failure, the most important thing
is the best practices should be the part of behaviour. Means on daily basis, by
following the SOP, no hidden things with FDA, and proper documentation. The
available SOP should be prepared as per updated regulatory guidelines and
requirements.
On other side the staff required who can explain
perfectly everything to the auditor whatever he asked. But it is too difficult
to find that person who is expertise in each and every activity. However the
auditor want to know from real person who performing the respective activity.
In that case the requirements of SME i.e. Subject matter expert exist.
Sometime the subject matter expert know the procedure
very well but in front of inspector, he/ she feels fear and could not give
answer properly. In that case bad impression goes to auditor and he understand
as untrained staff works in respective firm.
Selection of Subject matter experts (SMEs): It
is most important to prepare subject matter expert for completion of successful
FDA inspection. For selection of SMEs, it is required to evaluate the person to
decide which will be fearless in front of auditor and who will create more risk
in front of auditor. Several factor should be considered during selection of
SMEs.
1.
Competency in answering an inspector’s questions.
Your SMEs must be ready to answer questions related to the areas of risks you
have identified. They also need to be ready to provide clear explanations of
your system, your procedures and your associated records.
2.
Performance under stress. Consider how individual SMEs react to
stress. Will they keep calm or will they panic? Are they likely to respond to
inspectors’ challenges by passing the blame or pointing the finger at
management? Unnecessary to say, such loose cannons should never be allowed to
face inspectors.
3. Behavior and attitude. Think about the kind of impression an
individual may make on inspectors. Does he or she appear professional,
appropriately dressed and confident? Is his or her attitude one of openness and
cooperation or hostility and fear? Can the SME make eye contact and speak
clearly and with authority?
4.
Adaptability. Can the SME handle unexpected requests and
changes in tone or direction?
5. New personnel. If any of your key SMEs are new to their positions or to the company itself, they may need some extra coaching. They may need extra time to practice inspection interface skills and learn how to work with an inspector.
Trained your SMEs: After selection of SMEs it is most important to trend them to face the
inspector without any fear and give the answer properly to avoid offer any extra
digging point. As the auditors are too smart and trend to get information what
they want but if trained SMEs will be part of inspection team then most of
unusual things can be avoided.
The best way to trained
your SMEs is do Mock audit by external person or at high level of person of
your organization. Because of when the SME face them and sit on a hot seat he
will be trained to speak in front of unknown person or a person who is not his
or her regular teammate. By doing this activity you can also find the selected
SMEs is suitable or not for the inspection team or need extra training or it
should be changed with other person.
The SMEs should learn which type of questions can asked by inspector and recognize their methods and how to react to them. Inspectors typically ask several different kinds of questions that present varying levels of risk. Below are some examples of different type of questions:
1-Closed questions are narrowly focused and require only very brief answers, often simply “yes” or “no.”
2-Open-ended questions are designed to encourage the SME to talk and provide whatever information he or she wishes. They are very broad, such as “What can you tell me about …?” or “What do you think about …?” Inspectors often use open-ended questions to dig into complicated or sensitive areas.
3-Leading questions are phrased to suggest what kind of answer the inspector is seeking, such as “You don’t believe that process is effective, do you?” These questions usually crop up in the final stages of an inspection, sometimes after an SME has let some potentially damaging information slip.
4-Nondirective or neutral questions, such as “How do you like your job?” appear in the early stages of an inspection. Inspectors often use them to establish basic facts and identify potential issues.
5-Assumptive
questions—possibly
the trickiest kind—are designed to put the interviewee at ease and imply that
the inspector already knows and accepts the answer, so the SME feels free to provide
such type of information that is not required to share here.
Interview Dos and Don’ts with your Subject Matter Expert
Abhishek Singh is the author of Pharma technical support. He is pharmaceutical professionals, having experience of more than 12 years in Quality.