Pharmaceutical Manufacturing 101: How to Prepare for & Manage an FDA Inspection

  • February 24, 2016

By Paul Eichholz

Imagine for a moment that this is your current situation…

You receive a frantic call from the receptionist at your facility, an Investigator from the Food and Drug Administration (FDA) has just arrived for an inspection of the site.

Now take a moment to think about the circumstances…

Are you prepared? Is the investigator’s arrival going to cause panic, turning into a chaotic experience for your firm?

Whether it is for the approval of a new drug or a routine inspection, an FDA inspection should not be a painful experience. Ensuring that any regulatory inspection is a positive experience starts by creating a culture of compliance throughout the firm, and continues with on-going preparation and frequent inspection readiness practice.

Culture of Compliance

When it comes to being prepared for an FDA inspection, the rubric “practice makes perfect” does not apply on its own. It’s a combination of practice and preparation that makes the difference. An organization that is routinely successful in FDA inspections incorporates all aspects of compliance into its company culture, and has leadership that supports this culture on a daily basis.

As a pharmaceutical company, living a life of cultural compliance provides the foundation for a successful FDA inspection. The likelihood that a firm will be successful during an FDA inspection diminishes greatly in companies where compliance is not a priority. Although it is possible that an organization could get through one or two inspections, it is not likely that the success will continue if its day to day culture doesn’t demand compliance.

Inspection Preparedness

Does your firm have Standard Operating Procedures (SOPs) governing how to handle regulatory inspections? The answer should be: “Yes, there are procedures governing regulatory inspections, and all site personnel receive some type of training on these procedures.” Individuals who are most likely to interact with an FDA inspector should receive more detailed training on the regulatory inspection process. It is also important that everyone on site understands what happens when an investigator arrives for an inspection, including who should be contacted and how to interact with the inspector.

The initial interaction with site personnel sets the tone for the rest of the inspection. Personnel who are confident in what they are expected to do, react calmly to the inspector’s arrival, and follow the site’s procedure for handling an inspection are noticed by an investigator. This illustrates that the site takes the inspection seriously and that they know how to handle an inspection. Demonstrating control and preparedness indicates that compliance is an ongoing management priority.

Your firm should have a Site Inspection Management Team (SIMT) to handle all regulatory inspections. If you are a virtual firm, does your Contract Manufacturing Organization (CMO) have a dedicated SIMT? If the answer is no, you should be concerned about the CMO’s ability to successfully handle an inspection.

The SIMT should be comprised of individuals from several different areas and departments. The roles and responsibilities for each individual should be documented and the individuals should be trained and tested regarding their responsibilities. In addition, having a well-developed internal audit program is also a useful inspection readiness tool.

Members of the SIMT should include, but are not limited to:

  • Site Inspection Leader (Typically the Site Head of Quality Assurance)
  • Audit Control Room (War Room) Leader (Typically QA Director or Manager)
  • Subject Matter Experts (SME)
  • Scribes (Note Takers)
  • Escorts
  • Document Request Coordinator
  • Document Runners
  • Administrative Personnel

Subject Matter Experts

One of the most critical members of the SIMT are the Subject Matter Experts (SMEs). SMEs must be identified and selected based on their ability to completely and clearly answer questions from an investigator. It is important that they are not selected based on the length of time they have been at the facility, whether or not they are the department head, or due to the fact that they have the most knowledge about a particular subject or system.

SMEs must answer concisely, providing only the information that was asked for in a confident and intelligent manner. SMEs should also be well versed in answering questions about specific systems, issues, or challenges at the site, should they be asked by the investigator. Being able to appropriately address challenges and risks at the facility is critical to a successful inspection.

The SME must also perform well in stressful situations. How will they handle a question they do not know the answer to? Will they make up an answer that they think the investigator wants to hear? It is important for the SME to realize that if they cannot answer a question that is asked by the investigator, they must respond appropriately. In this type of situation, the SME should simply state that they are unsure of the answer, but will either get the appropriate answer and provide it or find the individual who is able to answer the question.

Furthermore, investigator questions should be answered using the facility’s SOPs. A typical response would be, “I am confident in the answer, but I want to verify that in the SOPs.” This shows that the SME understands how to use the SOPs, as well as their contents and purpose.

Regardless of the criteria used to select SMEs, a firm does not want to select the person that tends to say too much, volunteer information that wasn’t asked for, complain constantly, and/or does not act in a confident and professional manner when interacting with an investigator. SMEs should be trained regularly using simulated or mock inspections to ensure that they are ready for an actual inspection at a minute’s notice.

Successful regulatory inspections do not just happen, they require a company culture built on sustaining compliance, significant training and preparation, and flawless execution during the inspection. Most firms have challenges or issues of some type. It is how they are handled and addressed during an inspection that can be the difference between a successful inspection and enforcement activity taken by the FDA or other regulatory agency.

Part two is available now! Learn how to actively practice and prepare for an FDA inspection, and how to respond to the FDA after an FDA Form 483 is issued with our follow-up blog post, entitled “Pharmaceutical Manufacturing 101: Surviving an FDA Inspection.”


Does your firm need assistance in preparing for an FDA or other regulatory agency inspection? The Weinberg Group can help with GMP audits and beyond. Contact us today to learn how.