GMP Training Primer: Regulatory Inspection Preparation

Quality and regulatory staff aren’t the only people in your manufacturing operation that may become involved in or impacted by an FDA facilities inspection. Almost anyone on staff—from reception to senior management—is fair game to an FDA investigator. Make sure they all understand the rules of an inspection and the roles they may play by using the following training outline.

Part One – General Information

In this introductory section, explain the who, what, when and why of regulatory inspections.

• Who – Manufacturers and importers of drugs, medical devices and nutraceuticals all fall under the FDA’s GMP regulations and are subject to periodic inspections by the agency.
• What – The object of an inspection is three-fold: 1) to determine if violations of federal regulations are occurring; 2) to obtain voluntary correction of violations by the inspected facility; and/ or 3) to gather evidence for FDA enforcement actions, if necessary.
• When – Inspections may be routinely scheduled for general surveillance purposes or they may be “for cause” inspections to investigate a complaint, recall or other problem. Drugmakers’ facilities also are inspected prior to FDA approval of a new drug.
• Why – An FDA inspection is a critical business activity. Firms must be ready to present themselves in the best light and respond to any observations an investigator may make.

Part Two – Inspection Preparation

Discuss with trainees the methods the company uses to be in a constant state of inspection readiness. They should know who is responsible for handling an inspection—most often it is the quality control unit—and what their responsibilities are, including developing an inspection SOP, overseeing logistics and interaction with investigators, and responding to observations on an FDA Form 483, the document that lists all violations observed.

Many manufacturers use mock inspections to prepare staff for the real thing. In addition to demonstrating the importance of an FDA inspection, these practice sessions can help train employees to communicate effectively with investigators. They also are valuable tools for identifying potential problems that can be corrected before an inspection occurs.

Training also should introduce employees to the rules of an inspection, including what investigators are entitled to see and do, what requests can be denied and credentials investigators must present before being allowed access. Employees also should understand that inspections usually are unannounced and may occur at any time during the company’s normal business hours, including night shifts and weekends.

Part Three: During an Inspection

Trainees will need to know what role they and other personnel must play while an inspection is in progress. For instance, senior managers and subject matter experts may be interviewed formally by investigators, but anyone present in the facility must be ready to interact with investigators who approach them. Training in this area can make up an entire session itself, as demonstrated in the two-part course Surviving a Regulatory Inspection from GMPTraining.com.

Front desk and security personnel must know how to greet investigators, examine their credentials and notify the appropriate person or department of their arrival. The responsibilities of the company’s designated inspection “lead” include establishing and equipping a room or rooms for conducting the inspection, escorting investigators at all times, coordinating their requests for information, facilitating interviews, etc. The inspection lead also is responsible for holding a daily inspection wrap-up session to get investigators’ feedback and report to management on the progress of the inspection.

Part Four: After an Inspection

While most employees will not be involved in post-inspection activities, it’s important they know what happens at the end and after investigators leave.

Once they have gathered their observations, investigators will hold an “exit interview” with key managers. This gives managers a chance to discuss and clarify inspection findings and present any information that may mitigate problems found. If investigators determine the facility has violated any GMP regulations, they will present a Form 483 describing the citations. If the company receives a Form 483, it has 15 days to respond to the observations and outline any corrective actions and timelines.

Once the inspection has officially concluded, the inspection lead will prepare a detailed report on the entire inspection, including personnel interviewed and observed, documents reviewed, areas toured and investigators’ spoken comments. Even without a Form 483, a company may take the opportunity presented by an inspection to review its activities and make plans for the future.

For more guidance on inspection preparation, check out Secrets of QSIT-Based Medical Device Inspection Preparation or Inspection Preparation Training for Drugmakers from FDAnews.

Contact Information:
Dave Gallup
GMPTraining.com, Inc.
18585 Coastal Highway
Unit 10, #149
Rehoboth, DE  19971
215-870-5665
dagallup@gmptraining.com