Amy Scanlin, M.S. Technical Writer, Certified Group
An FDA inspection can be one of the most stressful parts of doing business. And while drug pre-approval and pre-license inspections—and most foreign facility inspections are generally pre-announced—FDA does not pre-announce “for cause” and routine domestic surveillance inspections.
That means you have a very short window to ensure your I’s are dotted and T’s crossed before FDA walks through the door. This wasn’t part of your plan when you came to work today, and you aren’t sure you’re ready. How do you prepare for the unexpected?
Some companies choose to facilitate inspection preparation by bringing in consultants who are former FDA investigators with specific expertise in their given commodity to assist with preparation for an FDA inspection. In other words, hiring a former FDA food investigator to prep for an API inspection may be less helpful than an investigator with pharma experience. When choosing a consultant, ask questions not only about their primary work field but their history of which companies they’ve successfully helped prepare for and manage FDA inspections.
The real preparation, however, begins long before receipt of FDA’s Form 482 Notice of Inspection. The real preparation is in the development and execution diligence of Good Manufacturing Practices (GMPs) using FDA’s 21 CFR 111 for dietary supplements or 21 CFR 211 for pharmaceuticals as a guide to setting minimum standards of safety. (For a list of FDA terms, acronyms and resources, please see “Back Page”, page 20.)
FDA will be assessing the robustness of your GMPs and benchmarking your inspection findings against them. Regardless of what has come before, here are three things you can do now to prepare for FDA’s arrival and facilitate a smoother inspection.
1. Look Up
Assessment checklists are nice, but if you forget to look up from the clipboard, you run the risk of missing catastrophic failures. Before FDA arrives, walk around. Watch your workers and ask questions, not just of the day shift but the night shift too. A consultant at EAS Consulting Group, part of the Certified Group of companies, once recalled an inspection where a serious sanitation failure was found on the underside of workers’ stools in a food production line. Sure, workers diligently washed their hands before pulling their stool forward to work, but they used those same now dirty hands at the end of their shift when they pushed those stools away. It is fortunate, he recalled, that the residue on the underside of the stools had not caused a major foodborne illness.
Look around. Attend overnight or early morning sanitation and pre-op meetings and inspections. Listen to briefs and chat with the workers. Ask questions. What are the product specifications? How often is a hazard analysis conducted and what interventions are taken? Are the interventions scientifically validated? What steps are taken to verify and document them?
FDA will be asking your employees these same types of questions. Ensure everyone on staff understands and is trained to perform their role effectively. Keep records of employee training events in their personnel files and maintain an open dialogue. Multiple choice quizzes at the end of webinars are nice, but having verbal confirmation and confidence that each party understands their job functions and expectations is critical.
2. Document
You’ve heard it before, but when it comes to FDA, if it isn’t written down, it didn’t happen. Documentation is key to demonstrating compliance. FDA is authorized to request records under section 704(a)(4) of the FD&C Act and they’ll do so by using an FDA Form 4003, FDA Inspection Records Request via email before the inspector arrives.
From Standard Operating Procedures (SOPs) to ensure every step of your process is developed and documented, to batch records that confirm SOPs were followed accordingly, ownership of these records and their processes is very important.
Adherence to the principles of ALCOA, where documents are Attributable, Legible, Contemporaneous, Original and Accurate demonstrates a commitment to data integrity. So, ensure that employees are documenting their steps, in ink, in real time along the way. Back filling data is not acceptable, and neither are erasures. If a mistake is made, it must be simply crossed out, not scribbled out, with the corrected information added, also in ink, alongside the initial of the person making the change. Do NOT use ‘White-Out’!
Speaking of change, Change Control must also be documented. When new equipment, raw materials, updated process or anything else that deviates from the SOP is used, document it. Adjust the SOP and add a new change control number that indicates this procedure should now be followed.
In addition to SOPs, FDA will want to see a staff organizational chart, floor diagrams of your facility, product catalogs and a record of compliant investigations… and they’ll want their own copy. Making a copy in advance of FDA’s arrival based on the documentation request in Form 4003 will help to expedite the inspection and demonstrate your cooperation. Cooperation may indicate to FDA that you have nothing to hide and are operating with at least a base acceptable level of regulatory compliance. One of the most important parts of FDA inspection of pharma facilities is the review of the complaints and other investigations, so ensure that investigations are well written and free of jargon known only to the firm. One or two sentences of explanation may seem burdensome to the author at the time, but they help the FDA investigator have his or her questions answered before they know they have them and demonstrates a high standard for quality enforcement.
3. Create an SOP for FDA Inspections
The time to decide how you’ll handle an FDA inspection is not upon receipt of Form 482. It is long in advance so that the execution of the inspection can be practiced and perfected. Who will meet the FDA investigator at the door? Which Quality Control and Quality Assurance managers will participate? Will you provide a “scribe” and a “runner” to also participate in the inspection? The scribe can be sure all the FDA’s questions are answered, that all documents are properly stamped, and keep a record of which persons the FDA spoke to and which documents are reviewed. The runner can bring requested documents from records to the FDA investigator. FDA will appreciate the active participation in the inspection.
FDA provides numerous resources that can help with the development of an FDA Inspection SOP. Examples include Compliance Inspection Guides and Investigations Operations Manuals. These tools are the very templates and instructions used by FDA investigators when conducting inspections and determining whether any regulatory enforcement action is needed. Pairing these documents with FDA Guidance Documents, which include cGMPs for every FDA commodity as well as Q&As and enforcement discretion announcements, will help you to develop and execute a plan for running an efficient FDA inspection.
Once your SOP is developed, practice it. SOPs are intended to be living documents. Like anything, repetition helps build experience, which in turn builds confidence. Don’t let your SOPs sit idle… any of them.
FDA is looking for a demonstration of safe practices and capable staff. By practicing the unexpected, you’ll be prepared.
About Certified Group: Certified Group is a North American provider of laboratory testing, regulatory consulting and audit and certification services. The Certified Group of companies includes Food Safety Net Services, Certified Laboratories, EAS Consulting Group, Labstat International Inc., Labs-Mart Laboratories, Advanced Botanical Consulting & Testing, Microconsult Inc. and Micro Quality Labs Inc. Certified Group provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, cannabis, nicotine and hemp industries.