Quercus Lab

In the world of pharma imports, maintaining Good Manufacturing Practice (GMP) standards is a shared responsibility that transcends borders. 🌎💊 The European Union (EU) stands at the forefront of this commitment, with two key regulatory documents underpinning the EU’s dedication to pharmaceutical quality and safety: Annex 16 and Annex 21. Learn about their global impact on public health in this blog post below.👇 https://hubs.li/Q02PFfcN0 #Pharma #GMP #Annex16 #Annex21

Ensuring the safety of medicinal products is our top priority. A crucial component of this is assessing the risk of #ElementalImpurities, which can originate from various sources such as raw materials, manufacturing processes, and packaging. 🔬 These impurities pose significant health risks, including toxicity and adverse reactions. Thus, it is essential to identify and control these impurities to ensure #PatientSafety. That's where #ICHQ3D guidelines come into play. These guidelines provide a framework for controlling elemental impurities in medicinal products. 💊 At Quercus, we offer comprehensive elemental impurity testing services to ensure your products comply with ICH Q3D guidelines. Our state-of-the-art laboratory and experienced team provide accurate and reliable testing, helping you meet regulatory requirements and guarantee the safety of your products. 🔍✔️ Our services include risk assessment, testing and analysis, and regulatory support. Want to know more? Get in touch with us! 👇 https://hubs.li/Q02Hrw0r0

Friability and disintegration testing are often overlooked during pharmaceutical development and testing, yet they are crucial in getting high-quality tablets to the patient. 💊🔎 In our latest blog post, we explore the importance of these tests and their vital role in pharmaceutical development and quality control. ✔️ 👉 https://hubs.li/Q02M9VdP0 #Pharma #QualityControl #Tablets

Did you know that Preservative Efficacy Testing (#PET) is a crucial step in ensuring your product's ability to combat microbial growth throughout its shelf life? 💡 Our team of microbiological experts at Quercus, part of the QbD Group, can support you with comprehensive PET testing services to ensure your #pharmaceutical formulation is compliant. 🔬 What is PET Testing? PET utilizes a microbial challenge methodology to assess the effectiveness of preservatives or a product's inherent antimicrobial properties. The product, ideally in its final packaging, is challenged with a range of microorganisms, including both Gram-negative and Gram-positive bacteria, yeasts, and molds.🦠🧫 Why is PET Important? PET testing plays a vital role in determining the microbiological stability of multi-use drug products like cough syrups and topical creams. These tests are often integrated into stability studies, typically performed at the beginning and conclusion, to verify the preservative's effectiveness throughout the product's shelf life. For more information on how PET testing can safeguard your product's efficacy and safety, reach out to our experts! 👇 https://hubs.li/Q02HqQ5Q0

Did you know that benzene, a well-documented human carcinogen, can contaminate drug products? This poses a significant health risk. 💊 Drug manufacturers must prioritize patient safety by conducting thorough risk assessments and implementing appropriate mitigation measures. In our latest blog, we delve into the risks of benzene contamination, regulatory guidelines, and essential best practices for ensuring drug safety and quality in manufacturing. 👇 https://hubs.li/Q02Ld4xX0 #Benzene #DrugSafety #Pharma

In the #pharmaceutical industry, ensuring the longevity, safety, and efficacy of medicinal products is paramount. StabilityStudies are crucial, providing data on how factors affect a product's quality over time. At Quercus, part of the QbD Group, we specialize in comprehensive stability studies to meet regulatory standards and maintain product performance throughout its shelf life. 🧪 What are Stability Studies? Stability studies test pharmaceutical products under various conditions to determine their shelf life and safety. These studies assess the impact of temperature, humidity, and light on a product's properties. 📋 Regulatory Guidelines We adhere to guidelines set by the #ICH, #FDA, and #EMA, ensuring our studies meet all #regulatory requirements. 🔬 Our Services: - Customized Study Design: Tailored to your product's unique characteristics and regulatory requirements. - GMP Compliant Storage: On-site, monitored storage for all ICH conditions. - Comprehensive Testing: Advanced techniques to assess product stability, including microbiology. - Ongoing Support: Continuous support from study design to final reporting. Contact us to learn more about our stability testing services! 👇 https://hubs.li/Q02HqPbw0

Are you currently struggling with the complexities of importing Investigational Medicinal Products (IMPs) into the EU? 🤔 At Quercus, part of the QbD Group, we understand the complexities and stringent regulations that comes with it. Our specialized services are designed to simplify this process, ensuring compliance and efficiency every step of the way. ✔️ Did you know many stakeholders are involved in the process of supplying a clinical study site with a Investigational Medicinal Product? - IMP Manufacturing site - QP Batch release site - QC testing site - Physical site of importation - Logistics - CRO - Sponsor of the study - Authorities With our comprehensive importation services, you can focus on your research and development of the product, while we take care of the regulatory and logistical challenges to bring your product to the EU. Contact us to learn how we can assist with the importation of your IMPs into the EU. https://hubs.li/Q02HqNX10 #ClinicalTrials #IMPImportation #PharmaceuticalLogistics #QualityControl #RegulatoryCompliance #PharmaServices #EURegulations

Did you know that simAbs and Quercus Lab partner together to get new treatments to the market? As an example, for an innovative company on a mission to remove animals from science and reinvent manufacturing methods for biomolecule, we recently combined our strengths to deliver the following services: SimAbs took care of bringing their product to the market in terms of #biologics development and manufacturing. We shared our expertise in clinical manufacturing and #QC testing and provided support on the following lab tests: • Bioburden • Purity (RP-UPLC) • Residual impurities (gas chromatography) This shows the power of #partnerships in accelerating progress and delivering life-saving treatments to patients faster. 👌 Want to know more? Get in touch! 👉 https://hubs.li/Q02nWg-S0

We are looking for a Lab/QC Manager to join our team at Quercus! 📢 Do you have a passion for quality control and experience leading a team in a GMP environment? Do you want to oversee the operational organization of our QC lab? Then we want to hear from you! 🫵 Apply today! 👇 https://hubs.li/Q02HnZHQ0 #QC #QualityControl #GMP #Vacancy

We are looking for a Lab/QC Manager to join our team at Quercus! 📢 Do you have a passion for quality control and experience leading a team in a GMP environment? Do you want to oversee the operational organization of our QC lab? Then we want to hear from you! 🫵 Apply today! 👇 https://hubs.li/Q02HnZHQ0 #QC #QualityControl #GMP #Vacancy