Ask the Expert: Preparing for and Managing Regulatory Inspections

An “Ask the Expert” webinar on 27 November 2018 featured Ray Marzouk, vice president of quality at Avid Bioservices, a biologics contract development and manufacturing organization (CDMO) in Orange County, CA. With six successful preapproval inspections behind it, Avid prides itself on a 13-year industry-leading regulatory track record.

Marzouk’s Presentation
Preparing for the Inspection: Implement a standard operating procedure (SOP) for inspections that includes instructions for the receptionist, host, scribe, subject matter experts (SMEs), and document finders. Prepare SMEs for interacting with investigators. Ensure sufficient back-room support for responding to document requests on time. Perform an unannounced mock inspection to evaluate how your people handle it.

Establish a strong quality management system. No matter how well versed a company is in conducting inspections, compliance with established quality systems throughout the year ultimately determines their outcomes. Routine internal audits can verify that compliance. Make sure that documentation is thorough and clear so no one has to address an investigator’s questions while reading incomplete/ incomprehensible reports.

Complacency is the enemy of compliance. Organizations should embrace continuous improvement and stay on top of regulatory and industry trends. Prevent gaps, but document those you identify and can justify.

Managing the Inspection: Set up a “front” conference room for the audit and a “back” conference room for the support team to gather documents and other items required by the investigator. Notify your organization that an inspection is occurring, ensure that executive management team members are present, establish the inspection scope, and have an opening presentation ready to give.

The host controls the overall flow and direction of an inspection. This person verifies credentials and ensures that investigators follow SOPs while they are on site. You need to know where the investigators are at all times and do not leave them unattended. Based on the type of documents requested, the host can arrange the order in which they are presented. He or she knows when to step in if problems arise and can assist SMEs as they address investigator questions. The host should check in occasionally with investigators and ask whether they have everything they need and are receiving documents as needed.

The scribe escorts inspectors at all times, documenting everything that occurs to make a record of the visit, communicating with the support room, and tracking the progress of requests. Support-room personnel will review documentation, make references available, and strategize with SMEs about gaps. A tracking system is needed for logging document requests, noting which documents investigators will take away, and when requests have been met. Runners provide documents to the host (not the investigators), who can present them in the company’s preferred order. Keep document requests flowing.

SMEs need to answer questions truthfully without volunteering unasked-for information, clarifying investigator questions but answering only those asked. Don’t assume anything or insult investigators’ intelligence by seeming arrogant or condescending. A good SME can remain calm in high-stress situations.

Investigators will want to tour the facility, so plan a sensible route (e.g., following the process flow from material receipt through the finished-goods shipping). Have someone sweep the route ahead of investigators. Make sufficient lab coats, gowns, and goggles available. Be flexible if an investigator wants to see something not on the preplanned tour route.

Know how far to defend the company’s position. Don’t be afraid to challenge an inspector — but be respectful. Acknowledge gaps and implement corrective actions if appropriate. Make sure that your responses match your documentation. Show that you are in control of the situation and confident in your quality systems.

Investigators evaluate and document objective evidence about GMP operations. Delays in document retrieval can make them bored, frustrated, or impatient and give the impression that you do not have control — or that something is being “cooked up” in the back room. Delays allow investigators to think of further questions. Transparency and timeliness create trust. Be truthful and fulfill document requests on time.

Questions and Answers
What if multiple inspectors want to split up? Try to keep them in the same room. If possible, make your front room large enough to split them up in different corners there. What if an investigator wants to take pictures of your facility? There is legal precedent for investigators being able to take pictures. Have someone (perhaps the scribe) take the same pictures for your records.

More Online 
The full presentation of this webcast can be found on the BioProcess International website at the link below.

Watch the full webcast now.