Jamison Wynn’s Post

Learn more about the inspection of injectable products for visible particulates in West expert, John Rech's blog!

Dive into the FDA Draft Guidance: “Inspection of Injectable Products for Visible Particulates” with John Rech's insightful blog post! Equip yourself with expert knowledge needed to achieve your next milestone. https://bit.ly/3CBOKFU #FDA #RegulatoryCompliance #AnalyticalChemistry

On June 18, 2024, the U.S. Food and Drug Administration (FDA) issued a final rule that governs current good manufacturing practices (CMPGs), certification, postmarketing safety reporting, and labeling requirements for certain medical gases. These regulations are aimed at fulfilling a longstanding request from the medical gas industry that FDA tailor these requirements to better fit the unique nature of medical gases. More than once, Congress nudged FDA to undertake this rulemaking. Keller and Heckman Partner David Joy provides explanation of the final rule and what it may mean for the medical gas industry. To read more, please click the link below: https://lnkd.in/eHAvRY83

Detection of Contamination in Sterility Testing Using 20 Vials Sterility testing, essential for ensuring the safety of sterile products, is typically performed using 20 vials. This sampling method provides a certain level of statistical confidence, approximately 90%, in detecting contamination across the entire batch. However, this assumption relies on the premise that contamination is evenly distributed. In cases where contamination is not homogenous, it may concentrate in certain areas of the batch, meaning that even if the 20 tested vials show sterility, the entire batch cannot be guaranteed to be contamination-free. Therefore, the strict application of GMP guidelines is crucial. A robust GMP quality system implements preventative measures at every stage of production, enhancing the reliability of sterility test results and ensuring sterility more effectively. While sterility testing serves as a final safety check, adherence to GMP standards ensures the safety of the entire production process, providing a comprehensive guarantee of product sterility and patient safety. #SterilityTesting #ContaminationDetection #GMPCompliance #QualityAssurance #SterileProducts #PharmaceuticalManufacturing #ProductSafety #QualityControl #MicrobialContamination #GoodManufacturingPractices #PatientSafety #SterilityAssurance #PharmaceuticalQuality #Biopharmaceuticals #BatchTesting #ContaminationRisk

Counterfeit medicines (public health and safety news): fake Botox in US supply chain. FDA excerpt: "[Counterfeit Botox] Found in Multiple States: Unsafe counterfeit versions of Botox (botulinum toxin) have been found in multiple states. The US FDA is aware of adverse events, including hospitalizations, linked to the counterfeit Botox. Symptoms included blurred or double vision, difficulty swallowing, dry mouth, constipation, incontinence, shortness of breath, weakness and difficulty lifting one’s head following injection of these products. These symptoms are similar to those seen when botulinum toxin spreads to other parts of the body. Federal law requires that all healthcare providers who dispense or administer prescription drugs purchase those products only from authorized sources. Manufacturers and distributors have a legal obligation, and duty of care, to take measures to prevent falsified medicines from entering supply chains. What are your responsibilities as a manufacturer, distributor or healthcare professional? Find out in an online Certificate GMP course: https://lnkd.in/dXX-s6xd Other cosmetic regulations at: https://lnkd.in/g8BgrumM #cosmetics #medicines #FDA #healthandsafety #counterfeitdrugs

It’s exciting to see the FDA release the final rule on Lab Developed Tests (LDTs) and I’m relieved that there is a significant grandfathering-in of existing #diagnostics marketed as LDTs. However, #lab builders beware - modifications to your LDT now that the final rule has been published could mean your #product will now be subject to #regulatory premarketing requirements and review. Now would be a good time to briefly press pause on any upcoming product launches and make sure you’re in #compliance! https://lnkd.in/gjyFqUyk

🚨 New FDA Guidance Alert! 🚨 FDA's June 2024 guidance on "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection" is a must-read for all industry professionals! 📋 🔍 Key Highlights: - Clear Definitions: Understand what actions the FDA considers as delaying, denying, limiting, or refusing inspections. - Compliance Expectations: Learn how to ensure your facilities and documentation meet FDA standards during inspections. - Inspection Protocols: Be aware of the specific behaviors and practices that could trigger compliance issues. - Consequences: Know the potential penalties and regulatory actions for non-compliance. It's crucial to make informed decisions when FDA investigators come knocking. Ensuring transparency, preparedness, and cooperation can significantly impact the outcome of inspections. Stay informed and compliant to maintain the integrity and safety of your products! 💊 #FDA #Regulations #Compliance #Pharma #MedicalDevices #InspectionReadiness #IndustryGuidance https://lnkd.in/dDz-fGXB

Are you prepared? Take a look at the latest TGA updates for Medical Devices including Software as a Medical Device (SaMD) and IVDs. Excerpt: "[The TGA has] removed the requirement for a mandatory audit if an approved overseas comparable regulator is used to support the device application. For example, a Class III medical device that has undergone assessment through the Food Drug Administration (FDA) will not require a mandatory application audit." - READ MORE at: https://lnkd.in/g-7v2Fb7 (visit PharmOut's news page). #TGA #compliance #GMP #cgmp #qualitymanagement #qualitymanager #medicaldevices #regulations #Australia #business #compliance

🔬 Pharma Safety Spotlight: Sterile Fill-Finish 🔬 The sterile fill-finish process is the final safeguard before life-saving medications reach patients. 🌟 Ensuring quality and compliance here is non-negotiable. Here’s why: 🔸 Patient Safety First: Contaminated or improperly filled medications can lead to severe complications. We’re talking about vulnerable patient populations! 💊 🔸 Regulatory Adherence: The FDA and EMA have stringent guidelines. Compliance isn’t optional—it’s a moral responsibility. 📜 🔸 Risk Assessment Matters: Identifying hazards (like microbial contamination) and implementing robust strategies is key. 🛡️ 🔸 Aseptic Techniques: Fundamentals for maintaining sterility. 🧤 Remember, every vial matters. Let’s protect lives together! 💙 👉 Learn more about sterile fill-finish : https://lnkd.in/eSnta9fu #PharmaSafety #QualityControl #PatientHealth #SterileFillFinish #AsepticTechniques #QualityControl #Pharmafocuseurope