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How to avoid non-compliance

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.

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Computer Software Assurance (CSA) in Pharma Industry First Steps to move from CSV to CSA) 

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.

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Automated software testing for the GxP world - QbD Group

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.

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UK’s Medicines Regulator Announces IT Roadmap

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.

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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.

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European Parliament adopts proposed amendment to MDR to extend transitional deadlines for certain Medical Devices 

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.

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Medical Device and IVD industry trends for 2023

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.

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5 tips to score a job as a Life Science consultant

Job fair season is upon us! Whether you’re looking for your first job or a new work adventure, we can all agree that applying for a job comes with a healthy dose of nerves. To make sure you are the best version of yourself, preparation is key! Want to succeed in your next interview and land your QbDream job in consulting? Put your foot in the door and kick it wide open with these 5 tips!

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Finding your way through the maze of international, European, and harmonized standards for medical devices - QbD Group

Finding your way through the maze of international, European, and harmonized standards for medical devices

It is important to understand how standards are written and how their references are constructed in order to properly reference them and purchase the correct version for your use.

In this blog entry, we explain the difference between ISO and IEC standards, what harmonized standards are, and how to use the appropriate standard references in your technical documentation. We also give you a hint on how to make sure you have identified all applicable standards for your products.

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Why self-inspections or internal audits are essential for your QMS

Self-inspections or internal audits are an essential part of your QMS. In addition to determining whether your QMS meets guidelines and standards, you can benefit from them in several ways. They allow you to get to know departments better, explain to people why certain quality processes are necessary, gather useful feedback for further improvements to the QMS, and you have a tool to check your readiness for external audits.

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Compressed gases in pharmaceutical manufacturing: best practices in microbial monitoring

Compressed gases in pharmaceutical manufacturing: best practices in microbial monitoring

Compressed air and other process gases are used in a lot of different steps during pharmaceutical manufacturing. Some examples are the use of compressed air in direct contact with products to clean, aerate, or move them through the processes or the using process gases in fluid pumps that take products through the production and filling processes. Compressed gases, such as nitrogen or argon, can also be used for blanketing or to spray or coat a product. The risks associated with the use of these gases, depend on the amount and type of product contact and based on this risk assessment, a suitable monitoring plan should be in place.

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Meet QbD Ambassador and Clinical Pharmacology & Pharmacometrics project lead Thomas Van Looy

At the QbD Group, we want to take into account the opinion of our employees. Therefore, our Board of Ambassadors was elected to represent the voice of all QbD’ers, within and outside of the group. Thomas Van Looy has been elected as one of our Ambassadors for 2022. Congratulations, Thomas! As an Ambassador, he loves to share his QbD Group experiences. Want to find out more about Thomas’ #QbDream job? Then don’t miss out on the interview below.

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EDQM and the CEP of the future - Certificate of Suitability - Qb

EDQM and the CEP of the future 

A certificate of suitability to the monographs of the European Pharmacopoeia (CEP) issued by the EDQM is considered to replace the relevant sections in the application for marketing authorization demonstrating the quality of substances for pharmaceutical use. The inclusion of a CEP in an MAA simplifies the review process for authorities and the submission procedures for industry. However, with the upcoming changes to the EU pharmaceutical legislation, the CEP procedure may be at risk. In this blog post, we outline the possible changes in the near future.

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