QRx Partners

There's an excellent Regulatory Affairs Professionals Society (RAPS) Twin Cities Chapter event coming up this month! QRx Partner Mark Swanson will be there as a featured mentor. Scroll for more info and event links: ✅ Gain valuable mentorship and career insights. ✅ Build connections with leaders across the Minnesota regulatory community. ✅ Learn best practices and strategies to grow in your regulatory career. Who should attend? ✅ Those aspiring to move into Regulatory Affairs, Regulatory Affairs Specialists, Regulatory Affairs Coordinators, and Regulatory Affairs Managers. This event is a meaningful way to develop professionally, expand your network, and get inspired by experienced leaders. Event on LinkedIn 👉 https://lnkd.in/gHZK-y9P Event website 👉 https://lnkd.in/g_K3KD6P #QRxPartners #QRxInforms #RAPS #MLV #regulatory #mentor #compliance #FDAcompliance #MedTech #HereForYou

😬 🦞 😂 #ThursdayVibes #HaveALaugh #FineDining

𝗪𝗵𝗮𝘁 𝗮 𝗬𝗲𝗮𝗿 𝗳𝗼𝗿 𝗤𝗥𝘅 𝗣𝗮𝗿𝘁𝗻𝗲𝗿𝘀! As 2024 wraps up, we’re proud to celebrate a year of growth, collaboration, and impact. None of this would have been possible without the incredible support of our clients, consultants, partners, and internal team. 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 𝗳𝗼𝗿 𝗯𝗲𝗶𝗻𝗴 𝗽𝗮𝗿𝘁 𝗼𝗳 𝗼𝘂𝗿 𝗷𝗼𝘂𝗿𝗻𝗲𝘆! 𝟱𝟱 𝗽𝗿𝗼𝗷𝗲𝗰𝘁𝘀 across diverse areas, empowering 𝟯𝟵 𝗰𝗹𝗶𝗲𝗻𝘁𝘀 to achieve their regulatory and quality goals. Our experts shared insights through 𝟯𝟯 𝗽𝗿𝗲𝘀𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻𝘀 at 𝟮𝟮 𝗶𝗻𝗱𝘂𝘀𝘁𝗿𝘆 𝗲𝘃𝗲𝗻𝘁𝘀, fostering innovation and knowledge-sharing. We launched new initiatives: 𝗾𝘂𝗮𝗿𝘁𝗲𝗿𝗹𝘆 𝗳𝗿𝗲𝗲 𝘄𝗲𝗯𝗶𝗻𝗮𝗿𝘀, 𝗯𝗹𝗼𝗴 𝗮𝗿𝘁𝗶𝗰𝗹𝗲𝘀, and a 𝗬𝗼𝘂𝗧𝘂𝗯𝗲 𝗰𝗵𝗮𝗻𝗻𝗲𝗹 showcasing our expertise. Our daily 𝗟𝗶𝗻𝗸𝗲𝗱𝗜𝗻 𝗽𝗼𝘀𝘁𝘀 continue to resonate with the industry, including the popular 𝘐𝘯𝘢𝘥𝘦𝘲𝘶𝘢𝘵𝘦 𝘙𝘦𝘴𝘱𝘰𝘯𝘴𝘦 series, sharing lessons from FDA Warning Letters. None of this would have been possible without the incredible support of our clients, consultants, partners, and internal team. 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 𝗳𝗼𝗿 𝗯𝗲𝗶𝗻𝗴 𝗽𝗮𝗿𝘁 𝗼𝗳 𝗼𝘂𝗿 𝗷𝗼𝘂𝗿𝗻𝗲𝘆! As we look ahead to 2025, we’re excited to build on this momentum. Are you ready to achieve your goals with QRx Partners by your side? #QRxPartners #QRxInforms #mlv #NewYear #gratitude #compliance #regulatory #quality #HereForYou

✒️Well, the choice was pretty easy for this week's Warning Letter as there was only one posted by the FDA. Once again, the focus is an OUS drug manufacturer failing to perform testing of incoming active ingredients, not validating or monitoring production processes, and not validating aseptic and sterilization processes. These are all pretty much Drug Manufacturing 101, i.e. - it's hard to claim they weren't aware of these requirements. However, the lessons to be learned here come more from FDA's assessment of the company's responses to the inspectional observations. Lesson 1️⃣: Again, a Manufacturer can't just rely on receiving Certificates of Analysis (CofA's) as meeting the requirement for ensuring ingredient quality and purity. At a minimum, you must have procedures for reviewing the content of the CofA's, monitoring data trends, and performing your own sample testing. On top of that would be Supplier Management procedures that include confirming that the Suppliers have validated the processes whose results are covered by the CofA's, and repeating confirmation periodically. Lesson 2️⃣: A Manufacturer can't address the above issue by promising to use a contract test lab for every lot. How will you know the test lab is using validated test methods? How will sampling be performed? How will nonconforming lots be handled? What are the criteria for acceptance? Lesson 3️⃣: A Manufacturer can't just promise to perform Concurrent Validation on all production processes without explaining how they will confirm that what's produced is acceptable for release. It's also required to establish how those processes will be monitored to demonstrate that they continue to be suitable and in control over time. Lesson 4️⃣: It's not sufficient to just claim to be ceasing production for the U.S. market. What would the plan be if production resumes? Lesson 5️⃣: If you're going to share with FDA that you intend to start producing cosmetics, the Manufacturer needs to understand that those are also subject to various regulations. Not surprisingly, FDA recommends engagement of a qualified consultant, and a complete independent review of the entire QMS and operations. As we've stated before, why would you assume that the same resources that got you into trouble will suddenly be capable of getting you out? Read the full Warning Letter here 👉🏻 https://lnkd.in/gBNdBDRK #QRxPartners #QRxInforms #MLV #FDA #InadequateResponse #HereForYou

As we close out 2024 and welcome in 2025, we want to thank you all for your continued support! Cheers to a safe New Year's Eve and a happy and prosperous New Year! 🥂 #QRxPartners #QRxInforms #NYE #NewYears #gratitude

Check it out! 👉 https://lnkd.in/gMjAKrTY #QRxPartners #QRxInforms #mlv #YouTube #HereForYou

Want to stay informed with us in the New Year? Get on our newsletter list by sending us a quick DM with your email, or send us a note at contact@qrxpartners.com. 😃 📧 #QRxPartners #QRxInforms #mlv #newsletter #HereForYou

As this is considered the week of giving, we're offering 5 Warning Letters to learn from! 1️⃣ A Quality Manager getting physical with an Investigator resulting in Warning Letter words like "shoving" and "hostile". Also: ❌ Not allowing employees to answer questions & berating them if they do ❌ Lying about the existence of requested records ❌ Not investigating the source of mold in products because the products are no longer being manufactured ❌ Not testing incoming active drug ingredients ❌ Using truck trailers for storage ❌ An observation that the Quality Unit appears to have no authority (our guess is because of the out of control Quality Manager) 👉🏻 https://lnkd.in/gS2smxyW 2️⃣ A foreign drug manufacturer using three active ingredient suppliers that are all on the U.S. Import Alert list, which implies a lack of supplier controls. Also: ❌ Not testing incoming ingredients ❌ Not testing the outgoing drugs made from them Still want to save money by purchasing prescription drugs from OUS sources? 🤔 👉🏻 https://lnkd.in/gGf7YB5x 3️⃣ How do you validate an EtO sterilization process without using WtO gas? The company apparently wasn't planning to report any adverse events given that their MDR procedure was missing certain elements like the criteria for reporting or how to submit a report to the FDA. Not surprisingly, the company hasn't bothered to create an Electronic Submissions Gateway account. 👉🏻 https://lnkd.in/gNY3My4Z 4️⃣ A tampon manufacturer adding CBD for pain relief without submitting a new 510(k). ❌ They took a cleared device and turned it into a combination product ❌ Unapproved diagnostic kit ❌ Inadequate complaint management process 👉🏻 https://lnkd.in/gu_ud89M 5️⃣ $18B company: ❌ One of their OUS drug production sites wasn't being watched carefully ❌ Multiple occurrences of testing worksheets without a final passing results ❌ And more! … 👉🏻 https://lnkd.in/eQuGhxPb In the end there's inadequately responding to Inspection Reports resulting in receipt of a Warning Letter, but more importantly is not understanding requirements in the first place, or even worse trying to ignore or find ways around them. In both cases, expert help, like that available from QRx Partners, is the solution. 🤝 https://lnkd.in/gZ6nw-9M #QRxPartners #QRxInforms #MLV #FDA #FDAcompliance #regulatory #compliance

🧐😂 #happyholidays #tistheseason #stockingstuffer #holidaymeme

Happy first day of Hanukkah to all who celebrate! Cheers!🕯️ ✡️