Preparing for Unexpected Lab Inspection Visits

CRA Tips for SIV preparation! SIV preparation is a comprehensive, methodical process to ensure the most effective SIV conduct. These tips will help facilitate the process. 👉1.     Read and confirm the exact process for SIV conduct from the monitoring plan. The monitoring plan should detail all visit aspects: systems utilized (EDC, ePRO, lab portals, central imaging vendors), protocol elements for review, investigator site file instructions, IP receipt, temperature monitoring, inventory, and confirmation instructions. 👉2.     Stay apprised of site activation status. 👉3.     Ensure the PI, and study coordinator/site staff are aware of any ancillary site staff that need to attend the SIV (pharmacy staff, raters, sub investigators). 🔥4.     Prepare an agenda detailing topics/categories/tasks for review/completion, time periods for each activity and whom from the site is required to attend. Organize timing and planning with the study coordinator so they can plan accordingly. Construct an adaptable agenda as unexpected changes may occur, and you will need to accommodate. Flexibility is key! 👉5.     Send required documents for site completion in advance of the visit. This will save everyone time and ensure at least some can be collected at the visit. 🔥6.     Track supply shipments and site receipt (lab kits, investigator site file, ePRO devices, IP, etc.), for inventory at the SIV. Check with the site before the visit regarding receipt or notification. 👉7.     Check site staff systems access to EDC, IVRS, SIP-whatever platforms are being used. Be sure to provide help desk information. 🔥8.     Prepare an abbreviated PI SIV presentation-just in case. Mark the slides and information required for PI review. Unexpected things happen and you may have a shorter amount of time with the PI to review protocol/study information. You can review the remaining information with site staff during the visit. 👉9.     If a sponsor representative is attending, be sure to liaise with them and provide them with the agenda, directions to the site and relevant information. 🔥10.  Bring printed copies of slides/material and ensure you have sent the slides and protocol to the site before the visit. 🔥11.  Arrive to the SIV early enough to allow for AV set up. The site may have a large monitor/screen that they want you to use for the protocol presentation to accommodate a large audience. If for some reason your laptop cannot connect successfully with their equipment, ensure you have brought a secondary monitor to compensate for this viewing. 

Preparing for an FDA inspection requires a strategic approach, and having expert guidance can ensure everything runs smoothly. Key Areas to Focus On for FDA Inspection Readiness: GMP Documentation Review - Ensure SOPs, batch records, and training logs are complete, current, and easily accessible. - Verify that change control, CAPAs, deviations, and complaints are properly documented and closed out. Mock FDA Audits & Readiness Training - Conduct a mock inspection to identify gaps before the FDA does. - Train staff on inspection behavior, common FDA questions, and how to present information effectively. Data Integrity & Quality Systems Assessment - Ensure electronic systems comply with 21 CFR Part 11 (audit trails, access controls, data accuracy). - Confirm that laboratory and manufacturing records are accurate, attributable, and traceable. Facility Walkthrough & Housekeeping - Ensure the facility is clean, well-maintained, and compliant with cGMP requirements. - Review storage conditions, labeling, and equipment calibration logs. Regulatory Risk Assessment & Compliance Gap Closure - Identify potential risks that could lead to 483 observations or warning letters. - Close out pending CAPAs and deviations before the inspection. Inspection-Day Preparedness - Establish roles and responsibilities (who speaks, who retrieves documents, who takes notes). - Prepare a war room for document retrieval and regulatory references. - Rehearse responses to tough FDA questions to ensure confidence and accuracy. Would you like a tailored FDA inspection readiness plan based on your company’s unique risk profile and regulatory history?

Saying an FDA investigator doesn't know much about microbiology may have been worked many years ago, or even decades ago. But that is no longer true. It’s a doomed strategy. Stop it now. Regulators are better trained and more well rounded on topics like Microbiology and Sterility Assurance. I know which systems some key investigators are trained on, and they include in-depth microbiology. This brings me incredible joy. So, 👎 Don't be caught off guard when an FDA investigator comes to your facility, loaded with microbiology knowledge. 👎 Dont be caught off guard when an FDA investigator is an actual microbiologist, more and more this is becoming the standard. 👎 Don’t be caught off guard when a regulator tours the lab, asks to observe microbiological testing or observe sampling in the classified areas. Those days are in the past, so please be well prepared to explain: 🔬Your test methods, 🔬Your risk assessments,  🔬Your monitoring programs,  🔬Your OOS & OOL investigation program,  🔬The technology you selected for the lab, 🔬Electronic systems and their validation 🔬Your equipment and instruments, 🔬Contamination control strategy, 🔬Your sterility assurance program,  🔬Your data management program, 🔬Organizational chart, training and education for analysts, 🔬Metrics and quality reporting structure, 🔬Aseptic techniques and behaviors program,  🔬Cleanroom controls including disinfection, gowning, MPP flows,  🔬Real time risk assessment and/or aseptic observer program, 🔬Governance for all the above. The days are over where regulators lack knowledge of microbiology.  Prepare yourselves, and your company. You do not want to be the one with an inspection report full of microbiology related observations. Either from the lab or on the manufacturing floor. Happy Friday. #RegulatoryPreparation #MicrobiologyIsTopPriority