Preparing for Lab Inspections

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. 

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

📝🔍 First Routine Monitoring Visit: Essential Documents for CRAs! 🔍📝   As CRAs, our first routine monitoring visit after the Site Initiation Visit (SIV) is pivotal in ensuring the smooth progress of clinical trials.   During this critical visit, there are several essential documents that we must diligently confirm, review, and collect to uphold data integrity and compliance. Let's highlight these key documents:   🔹 Informed Consent Form (ICF): Verify that the ICF is the most updated version of the document. If any patients were enrolled, ensure that each study participant or their legally authorized representative appropriately signed and dated the ICF. Confirm that the informed consent process followed regulatory guidelines.   🔹 Source Documents: Conduct thorough Source Data Verification (SDV) to validate that the Case Report Form (CRF) data matches the source documents, such as medical records, lab reports, and patient diaries.   🔹 Regulatory Documents: Collect and review essential regulatory documents, including the signed protocol, Investigator's Brochure (IB), IRB/EC approvals, Financial Disclosure Forms (FDFs), and any relevant correspondence.   🔹 Training Records: Ensure that all site personnel involved in the study have completed the required training, as documented in the Training Log or personnel files.   🔹 Site Delegation of Authority (DoA) Log: Verify that the DoA Log is up-to-date and accurately reflects the delegation of responsibilities among site staff.   🔹 Adverse Event Reporting: If an AEs or SAEs have been reported, review records of any reported adverse events (AEs) or Serious Adverse Events (SAEs), confirming appropriate documentation and follow-up.   🔹 Drug Accountability: Verify the accountability of investigational products, ensuring proper storage, dispensing and reconciliation of study medications.   🔹 Monitoring Visit Reports (MVRs): Confirm and review MVRs from previous visits, the SSV, and SIV, to ensure proper filing and retention, as well as tracking of site activities and any identified issues.   🔹 Study-Specific Logs and Worksheets: Check study-specific logs, such as the Subject Screening Log, Enrollment Log, and Randomization Log, to monitor study progress and patient recruitment.   A comprehensive review of these essential documents during the first RMV empowers CRAs to identify potential issues early on, ensure data accuracy, maintain regulatory compliance, and contribute significantly to the trial's success.   #ClinicalResearch #CRACareer #MonitoringVisit #DataIntegrity #RegulatoryCompliance #ClinicalTrials #ResearchExcellence #QualityAssurance

PPAP: The 18 Elements and Why They Exist → 1. Design Records What it is: The final, approved drawing. Why it matters: Sets the standard. No drawing = no target. → 2. Authorized Engineering Change Documents What it is: Any approved change to the original design. Why it matters: Ensures everyone is working off the latest version. → 3. Customer Engineering Approval What it is: Sign-off from the customer (if required). Why it matters: Confirms the customer has validated the part or change. → 4. DFMEA (Design Failure Mode & Effects Analysis) What it is: Risk analysis of the design. Why it matters: Catches weak points before the part hits production. → 5. Process Flow Diagram What it is: A visual map of the manufacturing process. Why it matters: Shows every step where failure can happen. → 6. PFMEA (Process FMEA) What it is: Risk analysis of the manufacturing process. Why it matters: Identifies process risks before parts are made. → 7. Control Plan What it is: The game plan for monitoring the process. Why it matters: Defines how quality will be maintained. → 8. Measurement System Analysis (MSA) What it is: Gage R&R, bias, linearity, etc. Why it matters: Ensures your measuring tools are reliable. → 9. Dimensional Results What it is: Actual measurement data on sample parts. Why it matters: Proves parts match the drawing. → 10. Records of Material / Performance Tests What it is: Material certs, lab results, functional tests. Why it matters: Confirms materials and functions meet spec. → 11. Initial Process Studies (SPC) What it is: Capability studies (Cp/Cpk) on key characteristics. Why it matters: Shows if the process is stable and capable. → 12. Qualified Lab Documentation What it is: Certifications for external labs used in testing. Why it matters: Verifies test results came from accredited sources. → 13. Appearance Approval Report (AAR) What it is: Visual inspection results (if appearance is critical). Why it matters: Confirms the part looks right. → 14. Sample Production Parts What it is: Actual parts from the production run. Why it matters: Physical proof the process can produce good parts. → 15. Master Sample What it is: A signed, approved reference part. Why it matters: Becomes the “gold standard” for future comparison. → 16. Checking Aids What it is: Jigs, fixtures, or templates used for inspection. Why it matters: Ensures consistent inspection methods. → 17. Customer-Specific Requirements What it is: Any additional requirements beyond the AIAG standard. Why it matters: Tailors PPAP to the customer’s expectations. → 18. Part Submission Warrant (PSW) What it is: The summary and formal sign-off document. Why it matters: The final “yes” that says everything is in place. PPAP is not just paperwork. It’s proof. It’s process control. And it’s protection — for both sides. If you skip it, you’re gambling with your launch.

✨Are you preparing your investigator site files (ISF) for an audit? Pay attention to the following items: ♦️Site responsibility log (SRL) or delegation log -Curriculum vitae (CV) and medical licenses are on file and current. -PI signed and dated delegated duties before involving staff in the study. -Updated log with additions and deletions in staff -Staff trained on the study before performing study-related duties ♦️Form FDA 1572 -PI’s name is consistent on the Form FDA 1572, CV, financial disclosure form, and medical license  -PI’s affiliation on the CV is consistent with the site address on Form FDA 1572. -List of all investigators and study staff in section 6. -Names, addresses, etc. are correct and consistent for all investigator sites, IP shipment addresses, laboratory facilities, and institutional review boards (IRBs). -Certification and normal reference range document names are consistent. -Correctly listed protocol number and title. -Form FDA 1572 is signed and dated by the PI with any changes initialed and dated by the PI. ♦️Financial disclosure forms -Present, original, signed, and dated for all staff on Form FDA 1572. ♦️Screening/enrollment log -Reason for screen failure or randomization date recorded for all screened participants. ♦️Protocol and amendments -All are on file and signed/dated by the PI. ♦️IRB communications -Documentation is complete (protocol; IB; ICF documents, etc.). -Filed IRB list or assurance letter and continuing review approval. -Notification and report of protocol deviations and SAEs  -ISF contains all IRB-approved documents. -The site uses approved/current versions of each document -Stamped IRB-approved ICFs ♦️Training and qualification documentation -Signed and dated current CVs containing name, education and qualification, current position, affiliation(s), and experience of staff. -Medical licenses are valid for the duration of staff involvement in the study. -Documented training of relevant staff on study materials, eCRF, and GCP. ♦️Investigational New Drug (IND) safety reports -Sponsor-submitted reports are present, submitted to the IRB, and documents PI review. ♦️Lab accreditation and reference ranges for laboratories -Accreditation is valid for the duration of the study, and reference ranges are on file and current. ♦️Communications -Documented correspondence about safety, protocol deviations, IRB notifications, and key study decisions. -Monitoring visit confirmation letters and follow-up letters are on file. -Documented evidence of timely resolution of issues.  -Safety questions, inclusion/exclusion criteria, and newsletters are present. ♦️Site visit log -All visits are recorded and consistent with monitoring visit documentation. ♦️Pharmacy file -Inventory records are up to date. -Documentation of IP dispensing, return, or destruction is present. -Determine if there is a separate delegation log in the pharmacy or included in ISF. #clinicalresearch #clinicaltrials

I started my pharma/biotech career many years ago in a CAP/CLIA lab, eventually moving from operations into quality assurance management. One of the routine activities we would do when the College of American Pathologists (CAP) would release their updated checklists was to perform a gap analysis against any new requirements and revisit any others to ensure we reflected our current practices. Each discipline supervisor/manager was asked to go item by item and fill in how the laboratory complied with each requirement on their portion of the checklists. We would then review their checklists together to ensure consensus. I'm certain this was common practice at most CAP-accredited laboratories, but realizing the potential benefits was crucial so that it wasn't relegated to just another checkbox exercise. This served as our storyboard in a way as it helped each department to be able to tell the story of how each requirement was met at our facilities. This was tremendously helpful when it came to facing auditors who would visit. Knowing compliance requirements is one thing, while knowing specifically how your organization meets those requirements is another. Being able to succinctly and cohesively speak about your procedures and processes during audits is incredibly impactful. What are some audit readiness and training strategies that you've seen or used that were successful? I expect these will be varied as every organization is different culturally and dependent on the services you are providing as well. #qualityassurance #regulatorycompliance

“The inspector’s at the gate.” That’s how the call started. No warning. No prep day. Just a knock on the door at 8:03 a.m. But this time? We didn’t scramble. We welcomed them in, offered coffee, and got to work. Because inspection readiness wasn’t a project. It was a practice. ⸻ 🧬 In biopharma, inspection-readiness isn’t about the audit. It’s about operational integrity. When you’re always ready, inspections become confirmation—not crisis. ⸻ 🔎 7 Steps to Be Ready—Always 1️⃣ Make Quality a Daily Habit Inspections shouldn’t change how we behave. Embed quality into your routines so audit-day looks like every day. 2️⃣ Prepare Your People, Not Just Paper 60% of FDA 483s stem from personnel issues. Train SMEs to be clear, confident, and calm under pressure. 3️⃣ Build a Back Room That Works Create a command center: document runners, scribes, response leads. Drill until “smooth” becomes your standard. 4️⃣ Simplify Document Access Can your team retrieve a deviation in 60 seconds? If not, you’re not ready. 5️⃣ Lead with Data, Not Reactions Inspectors want facts. Bring metrics, CAPA outcomes, and trends—ready and translated into your quality language. 6️⃣ Audit Yourself—Ruthlessly Run mock inspections quarterly. Use real checklists from FDA 483s and EMA findings. 7️⃣ Stay Curious, Not Complacent Read inspection reports across the industry. What blindsided them could blindside you. ⸻ 📊 Stat to Remember 72% of FDA 483s in biologics cite repeat issues. Being almost ready isn’t enough. ⸻ 🚀 What’s your 365-day inspection-readiness strategy? Drop a best practice below, or ♻️tag someone who runs a world-class audit program. ⸻ You could also save this post to use at your next team huddle. #GMP #InspectionReadiness #Biopharma #QualityLeadership #FDA #Compliance #PharmaQuality #OperationalExcellence #CGT #QualityCulture

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?

Cleanrooms are your first line of defense - but are you checking what really matters? In pharma, biotech, and life sciences, small oversights can have big consequences. 💡 Don’t miss these often-overlooked essentials: • Airflow direction and velocity matter more than volume alone • EMS alarms are useless without a clear, documented response • Pressure differentials must protect risk zones, not just hit specs Ellab’s Cleanroom Compliance Checklist walks you through how to go from good enough to inspection-ready—with practical, proven steps like: → Risk-based temperature & pressure mapping → EMS design that mirrors real-world dynamics → Calibration integrity tied to process impact → Environmental trend analysis that drives requalification This isn’t just about passing audits - it’s about protecting products, patients, and your team’s peace of mind. Because cleanroom control isn’t a one-time task. It’s a daily discipline. Now you know. (And yes, knowing is still half the battle.) 😉 Download checklist: https://lnkd.in/ekh_T_Wg #Cleanroom #Compliance #AuditReady #FreeChecklist #Ellab