Learn how periodic validation reviews maintain pharma system compliance, using risk-based analysis and real-time monitoring to ensure continuous improvement
Learn how technovigilance ensures medical device safety through post-market surveillance, tackling risks, compliance, and best practices.
Discover how combining unscripted and scripted testing ensures robust Computer System Validation (CSV) for compliance, accuracy, and system reliability.
Discover how strategic knowledge process outsourcing (KPO) is revolutionizing pharmaceutical drug safety departments, driving efficiency and innovation.
Manage yearly audits to ensure compliance and quality in pharma and medical devices. Learn key strategies and boost your QMS now!
Explore essential insights into the EMA Linguistic Review process for Product Information of medicinal products approved via the Centralised Procedure.
Effective communication can be the key to unlocking your company’s full communication potential, and that’s where skilled science writers come in, bridging the gap between complex research and clear, compelling narratives that drive engagement and growth.
Discover how outsourcing internal audits in your pharma company can boost compliance, optimize resources, and provide fresh, unbiased insights for continuous improvement.
Effective communication can be the key to unlocking your company’s full communication potential, and that’s where skilled science writers come in, bridging the gap between complex research and clear, compelling narratives that drive engagement and growth. At QbD Business & Communication our copy team are also scientists, but none of us are in the lab anymore. So, what happened?
Learn about the risks of benzene contamination in pharmaceuticals, regulatory guidelines, and best practices for ensuring drug safety and quality in manufacturing.
Discover the crucial role of friability and disintegration tests in ensuring the quality, safety, and effectiveness of pharmaceutical tablets.
Learn about Extractables and Leachables in pharmaceuticals, including regulatory guidelines, analytical techniques, and safety assessments.
Gain an insightful understanding regarding the current review timelines for clinical trial and amendment applications of the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
Learn about the EMA’s Article 31 referral procedure for assessing medicine safety and resolving concerns in the EU.
In the world of medicine, drug readability is a fundamental aspect to ensure safety and patient understanding. The purpose of the consultations is to ensure the proper interpretation of the package leaflet by the patients or users to whom the medicinal product is intended. However, it is worrying to note that many of the package inserts and drug labels are so complex that it is difficult for most people to understand them. In this blog, we will explore the importance of assessing the readability of human medicines and the methods used to measure it.
Learn how to transform scientific breakthroughs into compelling stories. Discover strategies to effectively communicate your research to diverse audiences with QbD.
Discover common pitfalls in analytical method transfers and learn strategies to avoid them for seamless drug development and manufacturing processes.
Discover how EU GMP Annexes 16 and 21 enhance pharmaceutical import quality and safety. Learn about their global impact on public health.
Achieving inspection readiness ensures you’re always prepared for regulatory inspections. Learn the steps to stay compliant and confident every day.
Learn how to implement PIC/S standards in hospital cleanrooms by 2026 to ensure quality, safety, and compliance in pharmaceutical preparations.
Explore AI’s transformative role in pharmacovigilance in Europe, enhancing drug safety and compliance with EMA regulations through advanced AI tools and legislation.
Learn how to strategically plan your business development efforts to avoid unexpected costs and ensure a successful product launch.
Explore how social media aids real-time drug safety monitoring and the challenges it presents in pharmacovigilance.
Discover the latest on EU regulations for In-House Devices (IHDs) under IVDR, ISO 15189:2022 updates, and MDCG 2023-1 guidance. Ensure compliance and patient safety.
Learn about nitrosamine impurities in medicinal products, their causes, regulatory guidance, and strategies for risk evaluation and mitigation.
Ever wonder what happens during a regulatory inspection? Let’s dive into what to expect, from the inspector’s arrival to the post-inspection. Learn how to prepare for a smooth inspection and avoid unnecessary anxiety.
IVD manufacturers must align ISO 13485 and IVDR for a compliant Quality Management System. This article explores key considerations for harmonizing these frameworks.
Learn how SCADA automation systems revolutionize efficiency and ensure regulatory compliance in pharmaceutical manufacturing.
As the IVD industry undergoes significant regulatory changes with the implementation of Regulation (EU) 2017/746 (IVDR), manufacturers are facing new challenges and requirements regarding post-market surveillance (PMS) and post-market performance follow-up (PMPF). In this article, we explore the importance of prioritizing PMS and PMPF under the framework of the IVDR.
Explore how PDE values impact cleaning validation in pharmaceuticals, ensuring safety and compliance with industry standards.
Explore the risks of elemental impurities in drugs and how the ICH Q3D guideline helps ensure product safety and compliance.
This article explores the importance of clinical evidence for In Vitro Diagnostic Medical Devices (IVDs) under the new European Union Regulation (EU) 2017/746 (IVDR), and the challenges manufacturers face in meeting these new requirements.
Inspection readiness tips: Learn how to manage fallout and improve with CAPA for better regulatory compliance.
Even with the European Commission’s proposal for extending the transitional period for IVDs, manufacturers should start building compliant Technical Documentation now. This article highlights the importance of proactive action despite the proposed delay.
Explore how Environmental Risk Assessment (ERA) helps ensure medicines heal us without harming the planet, balancing healthcare advances with ecological preservation.
The European Commission proposes extending the deadlines for complying with the new In Vitro Diagnostic Medical Devices Regulation (IVDR). This article explores the reasons behind the extension and what it means for manufacturers.
Discover how to navigate compliance with Article 117 of MDR for drug-device combinations. Ensure correct implementation with essential guidance.
Discover how Patient Support Programs (PSPs) and Pharmacovigilance enhance patient care, ensuring safety and compliance throughout the healthcare journey.
Explore the FDA’s final rule integrating ISO 13485:2016 into QMSR for medical devices. Understand impacts on manufacturers and how to comply by 2026.
This article explores why staying on track for IVDR compliance is still the best strategy for medical device manufacturers.
Discover what is required to declare equivalence under the MDR for medical devices in the EU.
Gain an insightful understanding into how the MHRA inspect the Pharmacovigilance services of an MAH for post-authorised products.
Explore how the AI Act impacts MedTech and Life Sciences, and how the QbD Group can guide you through its complexities.
We are pleased to share this meaningful article by two of our senior RA IVD consultants, Pieter Bogaert and Anne Paulussen, recently featured in RAPS
The Medicines and Healthcare Products Regulatory Agency (MHRA) recently announced the upcoming launch of the RegulatoryConnect portal, a groundbreaking step forward in regulatory management. During
The new ICH Q2(R2) is a complete revision of the guideline to include more recent application of analytical procedures and to align content with ICH Q14 “Analytical Procedure Development”.
The United States maintains a robust regulatory foundation for Digital Therapeutics (DTx), ensuring that they are supported by stringent regulatory measures, including clinical evidence and data protection management. Learn more here.
Discover how to create a GMP-compliant stability protocol for pharmaceuticals, ensuring product safety and efficacy throughout its shelf life.
In this blog post, we delve into the intricacies of Digital Therapeutics (DTx) regulation in the UK, especially in light of Brexit in January 2020.
In celebration of International Women’s Day, with ‘Inspire Inclusion’ as the central theme for 2024, we sat down with some of QbD Group’s power ladies.
This blog underscores the critical nature of regulatory compliance in the pharmaceutical industry. It stresses the importance of senior management’s commitment despite significant costs. Key elements like Corrective Action Preventive Action (CAPA) plans are highlighted, especially with the trend towards computerized solutions. Non-compliance risks severe financial consequences, necessitating proactive measures. Effective compliance programs encompass written procedures, designated personnel, training, communication, and monitoring. Compliance is increasingly seen as a strategic advantage rather than just a cost-saving measure.
Explore how to tackle current and upcoming toxicology challenges in the pharmaceutical industry, ensuring product safety and environmental responsibility.
In this blog post, we delve into the DTx regulations of Belgium and France, focusing on their reimbursement strategies and providing a glimpse into how other EU member states fare in comparison.
Explore the crucial role of Pharmacovigilance (PV) audits in ensuring drug safety and compliance, the process, and the challenges faced.
Find out what is required to maintain marketing approval for older devices in the EU.
When it comes to the regulation of Digital Therapeutics (DTx), Germany is pioneering new paths for its adoption. This blog post delves into the intricacies of Germany’s approach to DTx regulation.
GxP audits are the backbone of compliance and improvement. From risk-based planning to meticulous execution and compliance review, each step ensures organizational excellence. Embracing a PDCA (plan, do, check, act) life cycle approach streamlines processes and fosters consistency.
Quality and Regulatory Affairs: Discover the key elements of Quality Management Systems in the pharmaceutical industry for compliance and success.
For DTx manufacturers targeting the European market, compliance with regulation (EU) 2017/745 (MDR) is mandatory. Let’s delve into this regulatory aspect within the EU.
Continuous manufacturing in the pharmaceutical industry enhances efficiency and product quality. Learn about CM’s implementation, control strategies, and ICH Q13 guidelines.
Explore the rise of Digital Therapeutics (DTx), covering its regulatory landscape, reimbursement perspectives, applications, and the WHO’s vision for digital health. Delve into how DTx bridges healthcare gaps and the future of digital health.
Learn key insights to meet the extended MDR/IVDR compliance deadlines in time and ensure your device’s market access and patient safety.
Explore the MHRA’s new International Recognition Procedure (IRP) for medicines post-Brexit, and learn how to navigate regulations and the IRP’s two assessment routes for streamlined medicine registration in the UK.
Discover what is required to obtain and maintain marketing approval for Software Medical Devices in the EU.
Explore the crucial steps for obtaining CE approval for your medical device under MDR. Learn more about the key aspects of conformity assessment tailored to each device class.
On the path to qualifying a new GMP facility? Learn about frequent pitfalls and the best practices we recommend to handle them.
Qualification and validation projects play a pivotal role in guaranteeing that pharmaceuticals, medical devices, and ATMPs meet stringent regulatory requirements. Learn more about QbD Group’s Project Management Process here.
Are you a medicinal product manufacturer looking to import into the EU in line with EU-GMP import regulations? Be sure to read this article.
On 22 May 2023, Irdeto and QBD Group sat down to discuss the developments of the medical device regulatory landscape. Read the interview here.
In this blog post, we explore Computer Software Assurance (CSA), a modern alternative to traditional Computer System Validation (CSV), focusing on its crucial role in the pharmaceutical industry. Discover the key differences between CSA and CSV, the initial steps for transitioning from CSV to CSA, and why the CSA approach is increasingly important for ensuring system reliability, security, and compliance in drug development and manufacturing.
Explore the essentials of plasmid manufacturing and regulations for applications like gene therapy and vaccine development.
Oncolytic viruses and cellular immunotherapy are creating significant new potential in the fight against cancer. Learn more about the working mechanism, risks, and specific biosafety requirements to be considered for oncolytic viruses.
Discover the future of pharma: enhancing efficiency and cutting costs with paperless validation. Learn how to navigate the path to agility and innovation in the digital era.
In this blog post, we delve into the world of GMP-compliant design for climate chambers, unraveling the vital role they play in the stability testing of pharmaceutical products.
In this blog post, we address key regulatory guidelines for stability testing to ensure high-quality products meet regulatory requirements and patient needs.
In this blog post, we would like to share with you the different steps and required documents for the execution of the systematic literature review for the clinical evaluation of your medical device.
In this blog post, we will explore the various factors that influence the stability of medicinal products and the parameters that need to be considered during their storage.
AI, machine learning, blockchain, big data, and other buzzword technologies are making inroads into the biopharmaceutical sector, improving quality, traceability, and efficiency. Read more about how digital health is changing pharma here.
Discover the latest key changes in cleanroom qualification regulations, exploring the impact of the different test phases (qualification, classification, requalification, monitoring) with a focus on risk assessment.
Discover the importance of software validation in clinical trials. Learn how it applies to GCP and GMP systems. Stay ahead in the digital era.
In this blog post, we would like to share with you the definitions, time points, and resources required to execute a systematic State of the Art (SOTA) literature review as required.
In this blog post, we will delve deeper into the significance of stability testing in pharmaceutical development.
Discover how Pharma 4.0 is revolutionizing pharmaceutical manufacturing. Learn about the benefits, challenges and key components and how it improves efficiency, quality and patient safety.
In this blogpost, we are sharing our experience on the common gaps and hurdles that manufacturers are facing when undertaking this Systematic Literature Review (SOTA).
This article addresses the latest revision of EudraLex Volume 4 Annex 11 and provides a checklist for compliance. Download it now.
The past couple of years have borne witness to pivotal shifts in clinical trial approvals within the UK and EU. With the UK implementing the Combine Review system and the EU transitioning from a previous Directive to the EU Clinical Trials Regulation, both regions are aiming for enhanced efficiency, streamlined processes, and heightened transparency. Learn more here.
The EU Commission is proposing a general reform of pharmaceutical legislation. Read more about what this means for patients and the industry.
Maintaining computerized systems during the operational phase is critical to the proper functioning of organizations. In this article, we explore some of the best practices for doing so.
Explore the field of medical writing and the different types of medical writing projects in Healthcare. QbD Clinical is happy to help!
Struggling with CSV validation and testing automation? Tired of re-validating at every sprint? Discover expert tips to reduce time, and budget, and increase validation coverage in our latest blog post on automated software testing for the GxP world.
In this blog post, you will learn more about analytical method validation and the criteria to consider when validating your analytical method.
Although manufacturers will have more time to prepare their technical files for the MDR transition, it is wise not to delay implementation until the last minute. Learn how to plan MDR compliance for your medical device here.
The UK government introduced the Innovative Licensing and Access Pathway (ILAP) in 2021 to give patients quicker access to cutting-edge treatments and therapies by offering a streamlined approach to licensing and regulatory processes. Learn more about ILAP in this blog post.
QbD Group Ltd. attended the MHRA GMDP symposium, a highly anticipated annual event that brings together stakeholders in the pharmaceutical industry to discuss the latest trends and developments. Discover our insights here.
Want to introduce robustness into your software validation activities? In this article, you will learn what the Agile model is and how to use the GAMP 5 framework for agile development.
The EU GMP Annex 1 Manufacture of Sterile Medicinal Products was revised in 2022. In this blog post, we will provide a summary of the changes and our initial insights several months after the revision.
Annex XVI of the MDR EU 2017/745 lists products without an intended medical purpose that now fall under the MDR. In this blog post, you will learn more about the contents and requirements of the annex.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is developing a new IT system to streamline submissions related to product licensing and process licensing. The first release of the system is expected by the end of 2023, with subsequent releases incorporating wider elements such as medical devices and import notifications. An agile delivery model will enable continuous improvement based on user feedback.
Regulatory agencies impose internal audits and supplier audits in the pharmaceutical and medical device industries to ensure compliance with Good Manufacturing Practices and ISO standard requirements. These audits help identify potential problems that may affect product quality, efficacy or safety, and provide a mechanism for implementing corrective actions to minimize public health risks. In this blog post, we’ll discuss 7 key areas to focus on during internal or supplier audits.
Learn 8 logical steps to take prompt action when national competent authority inspection reports, EIRs, FDA Forms 483 or warning letters show non-conformities. Failure to act can have crippling consequences.
Come to see the QbD Group at stand #3G73 at CPHI Conference in Barcelona. And after the conference…Eat & Connect with lifescience professionals at our QbD’s CPHI Networking Drink.