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52 October 2016 Tablets & Capsules You've spent months, perhaps years, refining your product, process, and quality controls at your site. But have you considered how you'll show- case the results of your work when the FDA arrives at your doorstep for an inspection? How you manage the visit can be every bit as important to pass- ing the FDA's inspection as the techni- cal aspects of your operation. Since most organizations receive infrequent FDA inspections, a well- crafted plan is an invaluable how-to guide for both veteran and unprac- ticed FDA hosts. Most plans reside within the site's quality system and infrastructure and are managed jointly by the site's head of quality and the operations management team. Ideally, the plan is tailored to the site's opera- tional capabilities and provides detailed guidance to site personnel while retaining enough flexibility so they can react as the inspection evolves. Key elements of an inspection management plan include: A standard operating procedure. Review it periodically to ensure it aligns with recent FDA policies and accurately reflects the organization and its operational capabilities. Guidance for the site receptionist. As the FDA's first contact, this person should know, in detail, what steps to take when the FDA arrives. Provide a list of site personnel to notify when the FDA arrives. Instructions on how to interact with the investigator. Your colleagues' responses should be brief and pertain directly to the questions. Avoid acronyms and corporate jargon. Be truthful at all times and don't offer opinions. Anyone who speaks with investigators should only discuss items/areas they are knowledgeable about. Strive to educate, not lecture. A list of key staff and their respon- sibilities in the process. Assign some- one to lead the FDA's visit, address key questions, control the flow of informa- tion, arbitrate FDA requests, and keep management informed about the status of the inspection. This individual must also be able to gauge the tone of dis- cussions with the FDA investigators. Assign support personnel to staff the command center, including, note-tak- ers, document runners, FDA escorts, and sample/label collectors. Select subject matter experts (SMEs) to serve as the "face and voice" of the organization. Seek people who have a true technical understanding of their areas/operations. They don't have to be managers, but they must be able to clearly convey factual and relevant information to the FDA in a profes- sional manner. You'll likely need SMEs with knowledge about the analyti- cal/microbiology laboratories, quality assurance, deviations investigations and change management, raw materi- als management, manufacturing opera- tions, qualification/validation, and data management. Additional steps Your plan should also include: • Instructions for notifying site man- agement and key personnel about the FDA's arrival. Consider notify- ing off-site support groups and sis- ter facilities as well. • A process to ensure that individuals understand—before they enter the inspection room—why they are talking with the FDA and what they are expected to address. • Guidance for establishing a com- mand center, which should be equipped to print and copy docu- ments, track FDA requests, manage documents, review and keep a log of procedures, and record which documents the FDA reviewed ver- sus which it collected. • Policies for signing documents pre- sented by the FDA (affidavits, sam- ple collection forms/form 484s), tak- ing photos, giving investigators direct access to electronic systems, responding to form 483 inspectional observations, etc. Establishing these policies in advance will save time and minimize the potential for con- flicts with internal policies during an inspection. • The route to follow and the key points to address when giving FDA investigators their first look at the facility. A well-planned tour with relevant commentary will help set the tone of the inspection. • Guidance for managing the flow of documents, obtaining templates to be used during the inspection (note-taker forms, request-tracking sheets, forms for summarizing each day's inspection), retrieving data from electronic systems, etc. • Periodic training and rehearsals, which could include having an out- side entity (consultant, corporate quality unit, sister facility) conduct an unannounced mock inspection to evaluate the site's readiness and identify areas for improvement. Like a validation protocol, the insp- ection management process requires detailed planning and design before it's implemented. That way, when the FDA arrives, you and your colleagues can represent the organization, its processes, products, and people in the most favorable manner possible. T&C Bryan J. Coleman is the senior director, pharmaceuti- cal and device consulting services, at EAS Consulting Group, 1700 Diagonal Road, Suite 750, Alexandria, VA 22314. Tel. 571 447 5500. Website: www.easconsultinggroup.com. b a c k p a g e Have a plan before the FDA arrives Select subject matter experts to serve as the "face and voice" of the organization.