The EU GMP Annex 1 has made one message unmistakably clear: in sterile manufacturing, compliance is ...

Designing a dissolution test is rarely a purely theoretical exercise. In practice, teams must balanc...

Quality Assurance (QA) is central to pharmaceutical and biotech compliance, but maintaining a full i...

Single-Use Systems (SUS) have become a fundamental component of modern biopharmaceutical manufacturi...

Dissolution testing is a cornerstone analytical technique in pharmaceutical development and quality ...

Since 2024, the European Pharmacopoeia (Ph. Eur.) has included General Chapter 2.4.35 – Extractable ...

In the pharmaceutical industry, a Quality Management System (QMS) is the backbone of your compliance...

Environmental Risk Assessment (ERA) is a mandatory part of the marketing authorization process for m...

The adoption of AI in the pharmaceutical industry is accelerating, but at a much slower pace than in...

Validation has long been a cornerstone of pharmaceutical quality assurance. Yet for many organizatio...

For SMEs and biotechs expanding across Europe, scaling pharmacovigilance (PV) isn’t about adding peo...

As we strive to improve our health with new medicines, it’s crucial we don’t forget the impact these...

Annual Product Reviews (APR) and Product Quality Reviews (PQR) are non-negotiable in pharma. Yet whe...

Ensuring the safety and efficacy of pharmaceutical products involves more than just the active ingre...

Scaling pharmacovigilance (PV) across Europe is as much an organizational challenge as it is a regul...

High-Performance Liquid Chromatography (HPLC) remains a cornerstone of pharmaceutical analysis, enab...

In the ever‑evolving life sciences industry, digitization is no longer optional — it’s a strategic i...

Balancing human health, regulatory compliance, and environmental protection is becoming increasingly...

As pharma and biotech companies expand globally, one of the most underestimated challenges they face...

Since the FDA announced in May 2025 the expansion of unannounced inspections at foreign manufacturin...

The European Commission is revising Annex 11 of the EU GMP guidelines, and it’s about time. Annex 11...

In the pharmaceutical industry, maintaining precise temperature control is crucial for ensuring the ...

Pharmacovigilance (PV) is no longer just a regulatory requirement; it has become a strategic busines...

A Laboratory Information Management System (LIMS) is more than just software; it’s the operational b...

In the development of pharmaceutical products, ensuring the safety and compatibility of container-cl...

The pharmaceutical industry’s journey with nitrosamines has been one of the most significant quality...

Why TOC measurement matters in cleaning validation Most pharmaceutical and biopharmaceutical product...

Stability studies are essential in pharmaceutical and biotech development. They ensure your products...

As of February 2, 2025, Article 4 of the EU AI Act is in force. This means AI providers and deployer...

In regulated environments such as pharmaceutical manufacturing, laboratory research, and clinical tr...

The pharmaceutical industry has seen its fair share of revolutions. From early mechanisation to comp...

Ensuring the safety of authorised medicines doesn’t happen by accident. It takes a well-structured s...

GMP compliance isn’t just about ticking boxes; it’s a safeguard for patient safety and product quali...

What do you do when a healthcare professional emails your company about off-label use Or when a pati...

Balancing efficiency, cost, and compliance is a growing challenge for organizations—particularly in ...

In every Good Manufacturing Practice (GMP) laboratory, three priorities continuously compete for att...

Pharmacovigilance (PV) is vital to public health. According to the Spanish Agency for Medicines and ...

Annual Product Reviews (APR) and Product Quality Reviews (PQR) are essential for compliance in the l...

In the fast-paced world of biopharmaceuticals, innovation often means launching new products. But wh...

In today’s globalized and highly regulated supply chain, keeping pharmaceutical products safe and ma...

Over the past few decades, the pharmaceutical industry has seen a dramatic shift in how regulatory s...

Since August 25, 2023, the pharmaceutical industry has been operating under a new standard for steri...

Vaccines are among the most powerful tools in modern medicine, but monitoring vaccine safety doesn’t...

An Investigational Medicinal Product Dossier (IMPD) is a critical document required for clinical tri...

Cleaning validation plays a vital role in safeguarding patient health — particularly in multiproduct...

Audits play a central role in ensuring regulatory compliance, product quality, and operational integ...

With people, animals, and ecosystems more connected than ever, safeguarding animal health and veteri...

The COVID-19 pandemic wasn’t just a global health crisis — it was a wake-up call for how vulnerable ...

Drug packaging and manufacturing materials may seem inert, but they can release chemicals that affec...

In recent years, medicinal products for the EU market have been increasingly manufactured outside th...

Ensuring the safety and quality of injectable pharmaceutical products is critical, and one key aspec...

Analytical Method Transfers (AMTs) are a critical step in ensuring the reliable reproduction of vali...

Qualified Persons (QPs) play a crucial role in ensuring that medicinal products imported into the Eu...

Did you know that performing an Analytical Method Transfer (AMT) can significantly benefit your labo...

Elemental impurities in medicinal products and excipients are a major concern for regulatory authori...

In the European Union, ensuring the safety of human pharmaceutical products requires strict complian...

Pharmacovigilance Agreements (PVA), also known as Safety Data Exchange Agreements (SDEA), are essent...

Imagine this: a life-saving drug reaches a patient, but due to a small, undetected defect in its pac...

The Quality Audits should be managed according to the Quality Management System requirements , which...

The emergence of nitrosamine impurities In June 2018, regulatory authorities worldwide became aware ...

In pharmaceutical operations, effective software compliance is vital for regulatory adherence, data ...

In the pharmaceutical industry, maintaining software compliance is a continuous process that extends...

In the pharmaceutical industry, ensuring compliance in software systems is vital for safeguarding da...

Over the years the pharmaceutical industry has become one of the most highly regulated, second only ...

In an era where product safety and quality assurance are paramount, toxicological monitoring studies...

Pharmacovigilance is a cornerstone of patient safety and public health, ensuring that the benefits o...

What is REACH, and Why is it Important for Pharma and Life Sciences?

Sterilization validation is a vital process in the healthcare and pharmaceutical industries. It ensu...

The Scientific Symposium on Advanced Therapy Medicinal Products (ATMPs), organized by the Committee ...

With rapid advancements in medical technology reshaping healthcare, new devices and innovations are ...

Imagine your pharmaceutical company has rolled out new software to manage your drug manufacturing pr...

As healthcare and patient safety become more important than ever, pharmaceutical companies are total...

In the pharmaceutical and medical device industries, maintaining compliance with regulatory standard...

For Medicinal Products, the Product Information (PI) is a key document that provides a summary of of...

The life sciences landscape is vast, complex, and rapidly changing, so it can be hard to navigate. V...

In the dynamic healthcare industry, maintaining efficiency and compliance isn’t just a necessity—it’...

Scientists outside of science Many scientists catch the research bug as children. For some, the inci...

Benzene is a well-documented human carcinogen, and its presence in drug products poses a significant...

Friability and disintegration testing are often overlooked during pharmaceutical development or test...

In 2023, assessment timelines for Clinical Trial Authorization (CTA) applications and substantial am...

In the world of pharmaceuticals, ensuring the safety and efficacy of medicines is paramount. One cru...

What is drug readability and why is it important? Readability refers to the clarity and ease with wh...

So, you’ve made a huge breakthrough on a project you’ve been working on forever, or found that your ...

Analytical method transfers (AMTs) are a critical step in the drug-development timeline. AMTs often ...

In the world of pharma imports, maintaining Good Manufacturing Practice (GMP) standards is a shared ...

In a previous blog post, we talked about the various activities that take place during an inspection...

Starting January 1, 2026, hospital pharmacies globally must comply with PIC/S standards for their ph...

Getting monetary value out of all your R&D efforts is key to the long-term success of your busin...

The safety of medicines is a fundamental concern in the field of public health, and in Europe, pharm...

Did you know millions of patients are already discussing medications and side effects online? Social...

In a previous blog post “Regulatory Inspection Readiness: A Proactive Approach to CAPA and Complianc...

Imagine a world where countless operators meticulously monitored dials and switches, ensuring the pr...

Toxicology is fundamental throughout the drug life cycle, beginning with the evaluation of active su...

Elemental impurities might not be the first thing you think of when it comes to drug safety, but the...

“Send” – After weeks of collaboration with the operations team, legal advisors, and experts, a detai...

With the 2017 Medical Devices Regulation (MDR) fully operational from May 26, 2021, Article 117 has ...

Patient Support Programs (PSPs), as outlined by the Good Pharmacovigilance Practices (GVP) Module VI...

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has been conducting Good Pharmacov...

During a webinar held on March 12, 2024, they unveiled the features of Release 1 of this innovative ...

Introduction Did you know that the precision of analytical methods directly influences the safety an...

Stability testing forms the cornerstone of pharmaceutical quality, ensuring that medicinal products ...

Toxicology plays a pivotal role in the pharmaceutical industry, focusing on mitigating the adverse e...

In the complex and highly regulated world of pharmaceuticals, the synergy between Quality and Regula...

A significant shift towards continuous manufacturing (CM) is currently underway in the pharmaceutica...

One of the initial changes implemented by the UK’s Medicines and Healthcare products Regulatory Agen...

In pharmaceutical production, a GMP (Good Manufacturing Practices) facility stands as a testament to...

In the world of life sciences, ensuring the safety and efficacy of products is paramount. Qualificat...

In an era of increasing globalization, the pharmaceutical landscape is undergoing significant change...

In the rapidly evolving pharmaceutical industry, computerized systems play a vital role in drug deve...

Plasmids are used in various research and biotechnology applications, such as gene therapy, vaccine ...

Immunotherapy has become an important therapeutic alternative to surgery, chemotherapy, and radiatio...

Nowadays, pharmaceutical companies have an ever-increasing number of equipment, automation activitie...

Stability testing serves as the backbone of regulatory compliance for pharmaceutical companies, prov...

Ensuring the stability of medicinal products is crucial for maintaining their effectiveness and safe...

Digital health in pharma is not just an emerging trend; it’s shaping the future of the pharmaceutica...

In 2022, significant updates were made to the main standards that impact the qualification of cleanr...

Computerized systems have become an integral part of clinical research, from data collection to anal...

Stability testing plays a crucial role in the development of medicinal products, ensuring that they ...

Industry 4.0 refers to the fourth industrial revolution, and within the pharmaceutical industry, the...

What is EudraLex Volume 4 Annex 11? EudraLex Annex 11 serves as a reference document within the Euro...

The last two years have seen significant changes in the approval management of clinical trials. In t...

On 26 April 2023, the European Commission adopted a proposal for a new Directive and a new Regulatio...

Automated software testing is becoming increasingly crucial in the GxP world, where Pharma 4.0 is th...

What is Analytical Method Validation? Analytical method validation is a critical process in the phar...

Pharmaceutical, clinical, MD, and IVD companies pursuing robustness in their software validation act...

EU GMP Annex 1’s revision – the 2022 update to ‘ Manufacture of Sterile Medicinal Products‘ – aimed ...

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recently implemented a new organ...

Regulatory agencies require internal and supplier audits in the pharmaceutical and medical device in...

Pharmaceutical companies are often inspected by competent authorities to verify the manufacturer’s c...

Using software for your life sciences operations requires high integrity and security in the data pr...

The introduction of a new product into your company’s portfolio may require expanding your existing ...

Current regulations require written documentation for all existing products in the company; this doc...

In the post-COVID pharmaceutical landscape, electronic records and signatures are indispensable, gui...

Although no single best practice, standard, or guideline has been specifically enforced, competent a...

GAMP 5, which stands for “Good Automated Manufacturing Processes”, is an approach that has been wide...

Any company in the pharmaceutical or medical device industry with a certified GMP, GDP or ISO 13485 ...

In Belgium, medicine advertising is subject to specific legislation. The objective is to ensure the ...

A job in life sciences consultancy offers plenty of challenges, variety, career opportunities, and g...

Compressed gas standards The latest draft of Annex 1, Manufacture of Sterile Medicinal Products, int...

Ever wondered why it is necessary – and sometimes absolutely essential – to perform a Data Migration...

Changes in business needs or technology are inevitable. They often lead to the retirement or “decomm...

During the pandemic, electronic signatures gained tremendous importance for companies in heavily reg...

Before marketing a medicinal product, pharmaceutical companies must obtain a marketing authorization...

CAR-T cell therapy, a groundbreaking advancement in the pharmaceutical industry over the last 20 yea...

New to validating computerized systems? If so, it might be difficult to get started on this type of ...

Dendritic cells (DCs) are crucial cells in the initiation and regulation of the adaptive immune resp...

Natural Killer cells or NK cells are large lymphocytes (white blood cells) that play a crucial role ...

In the field of regenerative medicine, advanced therapy medicinal products (ATMPs) represent the nex...

T he global regenerative medicine market, including  direct-to-consumer stem cell therapy , is expec...

Industry 4.0 is currently revolutionizing the design, manufacturing and services of healthcare appli...

QP challenges in ATMPs Advanced Therapeutic Medicinal Products are – by definition – ‘advanced’. In ...

Today, only 18 cell and gene therapies have made it to the FDA approved therapies list. Only 14 have...

Regulatory Affairs plays a crucial role in the pharmaceutical industry, especially during drug devel...

Do you want to distinguish starting materials used for ATMPs from those used for transplants or tran...

How to guarantee medicine quality and patient safety To explain the quality by design methodology, i...

What does an automation pyramid entail? An automation pyramid visualizes the integrated layers of te...

Hurdles to be taken As ATMPs progress towards commercialization, engineering challenges increase alo...

What is the definition of ATMP? From the website of EMA: Advanced therapy medicinal products (ATMPs)...

Advanced therapy medicinal products (ATMP) is the group of therapies in which we use cells, genes, e...

What are ATMPs and what are the challenges? According to the European Medicines Agency (EMA), ATMPs ...

First of all, let’s take a look at the manufacturing flow of vaccines. The production process consis...

Imagine guiding someone through Excel’s myriad functions in a written manual. Where to begin? With b...

Falsified medicines could seriously harm the health of patients and may even put their lives at risk...

After months of revision and many questions raised, it now appears that the time is coming to implem...

Every day, patients around the world participate in clinical trials. Their contributions are crucial...

Serialization is rapidly emerging in the pharmaceutical world. To fight counterfeit drugs, more and ...

Some encounters have big consequences. When QbD’s CEO Bart Van Acker met Antleron co-founder Jan Sch...

Over the last couple of years, the data integrity topic has received more and more attention. Recent...