The Risk of Benzene Contamination in Drug Products: What Manufacturers Need to Know
Learn about the risks of benzene contamination in pharmaceuticals, regulatory guidelines, and best practices for ensuring drug safety and quality in manufacturing.
Life Sciences Blog
SHARING EXPERT KNOWLEDGE
Select a category
Select an industry
Friability and Disintegration for Oral Solid Dose Forms: The Forgotten Tests
Discover the crucial role of friability and disintegration tests in ensuring the quality, safety, and effectiveness of pharmaceutical tablets.
Toxicological Assessment of Extractables and Leachables (E&L)
Learn about Extractables and Leachables in pharmaceuticals, including regulatory guidelines, analytical techniques, and safety assessments.
Analysing MHRA Performance: Clinical Trial and Amendment Applications in the UK
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).
Article 31 Referrals in Pharmacovigilance: A Brief Overview
Learn about the EMA’s Article 31 referral procedure for assessing medicine safety and resolving concerns in the EU.
How to Assess and Improve the Readability of Medicines: A Complete Guide
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.
The Journey from Science to Story
Learn how to transform scientific breakthroughs into compelling stories. Discover strategies to effectively communicate your research to diverse audiences with QbD.
Analytical Method Transfer: Common Pitfalls and How to Avoid Them
Discover common pitfalls in analytical method transfers and learn strategies to avoid them for seamless drug development and manufacturing processes.
Elevate Pharma Imports with EU GMP Annexes 16 and 21
Discover how EU GMP Annexes 16 and 21 enhance pharmaceutical import quality and safety. Learn about their global impact on public health.
The Holy Grail: Achieving Inspection Readiness
Achieving inspection readiness ensures you’re always prepared for regulatory inspections. Learn the steps to stay compliant and confident every day.
Implementing PIC/S Standards in Hospital Cleanrooms: From Regulation to Application
Learn how to implement PIC/S standards in hospital cleanrooms by 2026 to ensure quality, safety, and compliance in pharmaceutical preparations.
The Role of Artificial Intelligence (AI) in Pharmacovigilance in Europe: Advances and Legislation
Explore AI’s transformative role in pharmacovigilance in Europe, enhancing drug safety and compliance with EMA regulations through advanced AI tools and legislation.
Curb Your Enthusiasm – How to Avoid Rushing into Your Business Development Efforts with Unexpected Cost Consequences
Learn how to strategically plan your business development efforts to avoid unexpected costs and ensure a successful product launch.
Social Media in Pharmacovigilance: Harnessing Online Conversations for Drug Safety
Explore how social media aids real-time drug safety monitoring and the challenges it presents in pharmacovigilance.
In-House Devices (IHDs): The Impact of IVDR, ISO 15189:2022’s Update, and MDCG 2023-1 in the EU
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.
Nitrosamine Impurities in Medicinal Products: Risks and Regulatory Insights
Learn about nitrosamine impurities in medicinal products, their causes, regulatory guidance, and strategies for risk evaluation and mitigation.
What to expect when being inspected?
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.
Why do I still need to look at my QMS under the IVDR if it is ISO 13485 certified?
IVD manufacturers must align ISO 13485 and IVDR for a compliant Quality Management System. This article explores key considerations for harmonizing these frameworks.
SCADA Automation in Pharma: Boosting Efficiency and Compliance
Learn how SCADA automation systems revolutionize efficiency and ensure regulatory compliance in pharmaceutical manufacturing.
Post-Market Success under IVDR: Prioritizing PMS & PMPF
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.
Impact of PDE Values on Cleaning Validation Design in Pharmaceutical Manufacturing
Explore how PDE values impact cleaning validation in pharmaceuticals, ensuring safety and compliance with industry standards.
Safeguarding Drugs: Controlling Elemental Impurities (ICH Q3D)
Explore the risks of elemental impurities in drugs and how the ICH Q3D guideline helps ensure product safety and compliance.
The Crucial Role of Clinical Evidence in IVDR 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.
Regulatory Inspection Readiness: A Proactive Approach to CAPA and Compliance
Inspection readiness tips: Learn how to manage fallout and improve with CAPA for better regulatory compliance.
Why start building IVDR-compliant Technical Documentation now?
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.
Environmental Risk Assessments (ERA) in Pharma: Balancing Health & Environment
Explore how Environmental Risk Assessment (ERA) helps ensure medicines heal us without harming the planet, balancing healthcare advances with ecological preservation.
Understanding the European Commission’s proposal for extending the transitional period for IVDs
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.
Drug-Device Combination Products and Article 117: How to Stay Compliant?
Discover how to navigate compliance with Article 117 of MDR for drug-device combinations. Ensure correct implementation with essential guidance.
Patient Support Programs: Enhancing Patient Care through Pharmacovigilance
Discover how Patient Support Programs (PSPs) and Pharmacovigilance enhance patient care, ensuring safety and compliance throughout the healthcare journey.
FDA’s QMSR Introduction: Aligning Device CGMP Regulations with ISO 13485:2016
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.
IVDR Transitional Extension: Why full speed ahead is still the best strategy
This article explores why staying on track for IVDR compliance is still the best strategy for medical device manufacturers.
Declaration of Equivalence for Medical Devices under the MDR
Discover what is required to declare equivalence under the MDR for medical devices in the EU.
A Deeper Dive into the MHRA Good Pharmacovigilance Practice (GPvP) Inspection Metrics and Findings
Gain an insightful understanding into how the MHRA inspect the Pharmacovigilance services of an MAH for post-authorised products.
Impact of the AI Act on the MedTech and Life Sciences Industry
Explore how the AI Act impacts MedTech and Life Sciences, and how the QbD Group can guide you through its complexities.
The Impact of EU IVDR on Clinical Trials
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
MHRA to Launch RegulatoryConnect Portal in the UK: A New Era in Regulatory Management
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
ICH Q2(R2) Validation of Analytical Procedures: An Overview of the Revised Guideline
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”.
Exploring the U.S. Regulatory Framework for Mobile Health
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.
How to create a GMP-Compliant Stability Protocol?
Discover how to create a GMP-compliant stability protocol for pharmaceuticals, ensuring product safety and efficacy throughout its shelf life.
Digital Therapeutics in the UK: The Post-Brexit Landscape
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.
We Celebrate “International Women’s Day” by Putting the Spotlight on the QbD Group’s Power Ladies
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.
How to avoid non-compliance in the pharmaceutical industry
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.
Toxicology Challenges in Pharma: How to Address Them?
Explore how to tackle current and upcoming toxicology challenges in the pharmaceutical industry, ensuring product safety and environmental responsibility.
The DTx Landscape in Belgium, France, and Their Inspiration from the German Model
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.
Pharmacovigilance (PV) Audits: Importance, Process, and Challenges
Explore the crucial role of Pharmacovigilance (PV) audits in ensuring drug safety and compliance, the process, and the challenges faced.
MDR Certification for Legacy Devices: Integrating Clinical Evidence for Compliance
Find out what is required to maintain marketing approval for older devices in the EU.
Digital Therapeutics (DTx) in Germany: Pioneering “Deutsche Gründlichkeit” with Quality by Design
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.
Quality Audits Management: Quality Audits managed according to QMS
Quality 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: Key Elements of a Robust QMS in Pharma for Compliance and Success
Quality and Regulatory Affairs: Discover the key elements of Quality Management Systems in the pharmaceutical industry for compliance and success.
The Rise of Mobile Health: Taking a Closer Look at the EU Regulatory Landscape
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: Enhancing Drug Production
Continuous manufacturing in the pharmaceutical industry enhances efficiency and product quality. Learn about CM’s implementation, control strategies, and ICH Q13 guidelines.
Mobile Health Ascending and the WHO’s Global Strategy on Digital Health
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.
Anticipate the Notified Body Rush: Ensure Timely MDR/IVDR Compliance
Learn key insights to meet the extended MDR/IVDR compliance deadlines in time and ensure your device’s market access and patient safety.
MHRA’s International Recognition Procedure Post Brexit: Navigating Medicinal Product Registration in the UK
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.
Understanding Software Medical Devices: Navigating the EU Regulations and Clinical Evaluations
Discover what is required to obtain and maintain marketing approval for Software Medical Devices in the EU.
CE approval for Medical Devices under MDR: key requirements for your device class
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.
Qualifying a New GMP Facility: From Pitfalls to Best Practices
On the path to qualifying a new GMP facility? Learn about frequent pitfalls and the best practices we recommend to handle them.
Navigating Project Complexities: QbD’s Project Management Process for Qualification and Validation Projects
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.
Importing medicinal products into the EU? A Brief Guide to EU GMP Compliance.
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.
Status of the medical device regulatory landscape: An interview between QBD Group and Irdeto
On 22 May 2023, Irdeto and QBD Group sat down to discuss the developments of the medical device regulatory landscape. Read the interview here.
Computer Software Assurance (CSA) in Pharma Industry: First Steps to move from CSV to CSA
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.
Understanding plasmids: small molecules with big implications
Explore the essentials of plasmid manufacturing and regulations for applications like gene therapy and vaccine development.
Oncolytic viruses: the use for cancer immunotherapy
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.
Paperless Validation in Pharma: embrace the future
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.
GMP-compliant design of climate or stability chambers: the key to ensuring product integrity
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.
Regulatory guidelines for stability testing: a brief overview
In this blog post, we address key regulatory guidelines for stability testing to ensure high-quality products meet regulatory requirements and patient needs.
State Of The Art Literature Review – Process and Documentation
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.
4 Factors Influencing the Stability of Medicinal Products
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.
Digital Health in Pharma: Revolutionizing the Industry from R&D to Patient Care
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.
Mastering Cleanroom Qualification: navigating the latest regulatory updates
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.
Computerized System Validation in clinical trials: key considerations
Discover the importance of software validation in clinical trials. Learn how it applies to GCP and GMP systems. Stay ahead in the digital era.
State of the Art (SOTA) Literature Review – What, Why, When, and Who?
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.
The Importance of Stability Testing in Pharmaceutical Development
In this blog post, we will delve deeper into the significance of stability testing in pharmaceutical development.
Pharma 4.0: The Future of Pharmaceutical Manufacturing
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.
Clinical Literature Review – Common Gaps and Hurdles to Take
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).
EudraLex Volume 4 Annex 11: compliance checklist and future prospects
This article addresses the latest revision of EudraLex Volume 4 Annex 11 and provides a checklist for compliance. Download it now.
A Deep Dive into Clinical Trials Regulations: Shifts and Strategies in the UK and EU
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 Proposes a General Reform of Pharmaceutical Legislation – What it Means for Patients and the Industry
The EU Commission is proposing a general reform of pharmaceutical legislation. Read more about what this means for patients and the industry.
How to keep computerized systems in the operational phase?
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.
Types of Medical Writing: Introduction to the Art of Medical Writing in Healthcare
Explore the field of medical writing and the different types of medical writing projects in Healthcare. QbD Clinical is happy to help!
Automated software testing for the GxP world
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.
Analytical Method Validation: are your analytical methods suitable for intended use?
In this blog post, you will learn more about analytical method validation and the criteria to consider when validating your analytical method.
MDR transition: how to plan MDR compliance for your Medical Device?
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.
ILAP: Introduction to the UK’s Innovative Licensing and Access Pathway
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.
MHRA GMDP Symposium: key insights, trends, and best practices
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.
What is the Agile model in Computerized System Validation?
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.
EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products – Summary and first insights
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.
MDR Annex XVI: products with non-medical purpose — Compliance and Common Specifications (CS)
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.
UK’s medicines regulator announces IT roadmap
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.
7 key areas to focus on during internal or supplier audits
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.
8 steps to successfully respond to non-conformities in an inspection report
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.
Celebrating International Women’s Day with power lady Elly De Bruyn, CHRO at the QbD Group
In celebration of International Women’s Day, we sat down with Elly De Bruyn, Chief Human Resources Officer (CHRO) at the QbD Group, to talk about her experiences and views as a power lady in the life sciences industry.
Introduction to Digital Health in Clinical Trials
Learn how digital health is transforming clinical trials. Explore the benefits and challenges of implementing digital technologies.
What is the GAMP 5 V-model in Computerized System Validation?
Want to introduce robustness into your software validation activities? In this article, you will learn what the GAMP 5 V-model is and the key steps within it.
Essential Documents in Clinical Investigations with Medical Devices: a brief overview
This blog post provides an overview of essential documents required during medical device clinical investigations in accordance with ISO14155:2020.
The European Parliament adopts proposed amendment to Medical Devices Regulation 2017/745 (MDR) to extend transitional deadlines for legacy Medical Devices
The European Parliament has approved a proposal to extend the transitional deadlines for certain medical devices under the MDR to ensure availability of devices whose certificates have expired or will expire before 26 May 2024. Manufacturers must adhere to specific conditions to comply with the new transition periods. Learn more here.
Qualification of laboratory equipment: key considerations and challenges
Are you about to qualify your laboratory equipment? If so, here are the key considerations and challenges to consider.
UDI for software: how to mark your MDSW with a UDI?
Each individual medical device must have a Unique Device Identifier (UDI) with its carrier (barcode or QR code). But what about medical device software? Read the answer in this article!
Are systems in compliance with ISO 80002-2 if we follow the guidelines described in GAMP5?
Can the computerized system validation used in pharma be applied to non-product medical device software? In this article, we compare ISO 80002-2 with GAMP5 to find out.
Medical Device and IVD industry trends for 2023
In 2023, the IVD industry will continue to dominate the medical technology market due to rising demand for early diagnosis, treatment and point-of-care testing. Product trends include the accelerated consumerization of diagnostics, the rise of telemedicine and digital health, the growth of devices enabling personalized medicine and the emergence of AI and robotics-powered medical devices. Medical device manufacturing will undergo changes in the computerized system validation process due to the increased focus on critical thinking by GAMP5 and FDA.
Subscribe to the Blog
Here you will find interesting articles and news related to your industry.