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pharma

What is EU GMP Annex 11? EU GMP rules, also known as the ‘EudraLex rules’ govern the medicinal products in the European Union. The EU GMP rules are split into three different parts plus about 20 annexes. ‘The EU GMP Annex 11’ is one of the supplement...

Regulatory frameworks for Artificial Intelligence (AI) in the pharmaceutical and medical device industries are undergoing significant changes to meet the challenges and opportunities posed by this technology.

The pharmaceutical industry is rapidly evolving, and the number of AI application integrations is increasing day by day, reshaping every facet of pharmaceutical processes from drug discovery to supply chain management.

5 min read.

This is a story of triumph over tragedy. A story shaped by pivotal events that stress the importance of regulatory oversight in the production of pharmaceuticals and other medical products. This is the story of how the Good Manufacturing Practices (G...

5 min read.

Before a drug is suitable for patients, it must pass rigorous testing and cost-benefit analyses. In this post, we will discuss the journey a new medicinal product must take from the lab to final authorization in the EU. Continue reading this post to ...

5 min read.

We all know the EU GMP Annex 1 guideline: Manufacture of Sterile Medicinal Products. Yet manufacturing is evolving, and new technologies have emerged in recent years. It’s important that companies in the Life Sciences stay on top of these changes.

8 min read.

The pharmaceutical industry has a responsibility to prioritize sustainability, but unfortunately, it has not always done so in the past. At present, sustainability is often viewed as a trendy buzzword, used by companies to improve their public image ...

5 min read.

The pharmaceutical industry is one of the most rapidly evolving industries in the world, with new advancements and breakthroughs being made every day. Keeping up with the latest pharmaceutical industry news can be challenging, but fortunately, there ...

4 min read.

While the pharmaceutical industry continues to grow and evolve, GMP (Good Manufacturing Practice) compliance remains a top priority to ensure the safety and quality of products. Therefore, GMP is essential to every pharma manufacturing process to mai...

Even an organization with stellar leadership and a solid core of employees experiences hiccups from time to time. Despite having assembled all the ingredients for a great organizational culture or a superior product, a company or department is not li...

medical devices

The world of medical devices is steeped in regulations - you can't say medical devices without saying compliance. In this world of medical device regulations, compliance is critical. It ensures the safety and efficacy of products entering the market ...

While sometimes deprioritized, regulatory compliance is critical for medical device manufacturers. And among the global regulatory frameworks, the Medical Device Single Audit Program (MDSAP) has gained prominence over the past decade. MDSAP is a comp...

Having the FDA knocking on your door for medical device inspections is scary! But the management of FDA inspections for medical devices is a critical aspect of ensuring compliance with regulatory standards and maintaining the integrity of the medical...

The United States Food and Drug Administration (FDA) is the regulatory body responsible for the safety and efficacy of medical devices in the United States. The 510(k) clearance is their classic premarket clearance for Class II medical devices that m...

Quality management is the foundation of medical device manufacturing, as it interlinks with every aspect of the process, from design and development to post-market surveillance. Quality management systems (QMS) are deeply entrenched in the industry a...

5 min read.

Medical devices are a vast category of equipment, treatments, and functional aids, ranging from caries detection software to contact lenses, orthopedic implants, respiratory care, and more. Every person will need a medical device at some point or ano...

6 min read.

Developing and bringing a medical device to market is a scary process. Not only do you have to come up with a great idea or design improvement and develop a working prototype, but you must also ensure the device is safe and performs as intended in an...

7 min read.

ISO standards are some of the most recognized global harmonized standards currently at work, along with the standards issued by IEC.

4 min read.

Medical devices have one purpose: to improve the life of patients. They are developed with this purpose in mind, and the entirety of regulatory compliance is designed to ensure that medical devices remain safe and perform as intended throughout their...

8 min read.

Any medical device manufacturer developing new products comes across design verification and validation. They are essential stages during the design control of a new medical device. Design controls are a series of steps and processes during the devel...

compliance

Root Cause Analysis (RCA) is a systematic process used to identify the underlying cause or causes that lead to a problem or incident, with the goal of preventing its recurrence in the future. It is a systematic approach employed in various industries...

5 min read.

Ensuring compliance with 21 CFR Part 11 and EU GMP Annex 11 is crucial for any Life Sciences company using computerized systems in this highly regulated landscape. Both 21 CFR Part 11 and EU GMP Annex 11 act as safeguards for the Quality, integrity, ...

5 min read.

We all know the EU GMP Annex 1 guideline: Manufacture of Sterile Medicinal Products. Yet manufacturing is evolving, and new technologies have emerged in recent years. It’s important that companies in the Life Sciences stay on top of these changes.

7 min read.

ISO standards are some of the most recognized global harmonized standards currently at work, along with the standards issued by IEC.

4 min read.

While the pharmaceutical industry continues to grow and evolve, GMP (Good Manufacturing Practice) compliance remains a top priority to ensure the safety and quality of products. Therefore, GMP is essential to every pharma manufacturing process to mai...

The US FDA (Food and Drug Administration) is known for many things. However, adaptability and the willingness to harmonize with other regulatory agencies worldwide might not be one of them. Nevertheless, in 2018 the FDA began work to reconcile the US...

Top 11 FAQs about GMP Guidelines for Quality Management Systems The GMP guidelines are mandatory in most countries for pharmaceuticals, medical devices, and food industries. Companies that fail to comply with these guidelines can face severe regulato...

What is GAMP 5? GAMP®5 is an acronym for the guideline Good Automated Manufacturing Practices issue 5. The GAMP 5 guideline provides a risk-based approach to designing, developing, and maintaining computerized systems in a GxP-regulated environment. ...

What Are ATMPs? ATMPs is an acronym for Advanced Therapy Medicinal Products. These medicinal products are based on genes, tissues, or cells. Research shows that ATMPs provide promising therapeutic applications for Alzheimer's disease, cancer, muscula...

Internal audits can strengthen the quality management system (QMS) of your organization by improving sub-processes by identifying open issues and opportunities. In addition, internal audits can be more informal than external audits so that your organ...

quality management

The world of medical devices is steeped in regulations - you can't say medical devices without saying compliance. In this world of medical device regulations, compliance is critical. It ensures the safety and efficacy of products entering the market ...

What is EU GMP Annex 11? EU GMP rules, also known as the ‘EudraLex rules’ govern the medicinal products in the European Union. The EU GMP rules are split into three different parts plus about 20 annexes. ‘The EU GMP Annex 11’ is one of the supplement...

According to the U.S. Food and Drug Administration (FDA), data integrity is the completeness, consistency, and accuracy of data. The agency places a significant emphasis on data integrity in regulated industries such as pharmaceuticals, biotechnology...

An eQMS is a digitalized Quality Management System where you can create, store, retrieve, and archive all of your company’s quality-related documents. In the context of a life sciences company, an eQMS also automates compliance requirements under 21 ...

If you’ve been on the lookout for a go-to resource offering valuable tips for technical writing, your search is finally over. We’re here to simplify complexity.

Quality can help organizations drive compliance and growth, as well as reduce costs, by shifting from being an operational compliance issue to a strategic business initiative.

Life science industries have their language and it consists of many concepts, terms, and abbreviations that are commonly mixed up. When you see them together it is even harder to grasp the nuances between concepts. Today we’ll give you a long list of...

Root Cause Analysis (RCA) is a systematic process used to identify the underlying cause or causes that lead to a problem or incident, with the goal of preventing its recurrence in the future. It is a systematic approach employed in various industries...

We all know that in the European Union, Life Science companies that export to the United States must comply with 21 CFR Part 11. The regulation, overseen by the US Food and Drug Administration (FDA), oversees electronic records and electronic signatu...

5 min read.

2023 is almost over. Oh how time flies! As we are entering the last quarter of the year, there are still plenty of conferences and trade shows for you to attend. These events are a great way to stay on top of today’s rapid and sometimes overwhelming ...

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