In June 2022, the European Medicines Agency (EMA) published its first review of the 3-year work plan for the Quality domain (covering January 2021 to December 2023), highlighting interesting strategies and goals applicable to the Life Sciences indust...
Seasoned Pharmaceutical Quality expert Lieve de Wolf (External Quality Manager CAR-T & Advanced Therapies at QbD Group), joined our inaugural annual Scilife Summit to answer everything you wanted to know about novel GTMPs and ATMPs, specifically ...
The new year is a perfect time to plan for the conferences and events that will keep you in the loop for the latest and greatest in the pharma and biotech world. Here, we’ll look at some of the biggest events and most important conferences to attend ...
21 CFR Part 11 stands for Part 11 of Title 21 of the Code of Federal Regulations. The US FDA issued this final Part 11 regulation in March 1997, which became effective in August 1997. It governs the FDA regulations for electronic signatures and elect...
Understanding current Good Manufacturing Practices (cGMP) in the pharmaceutical industry can be challenging. That’s why Quality professionals in the pharma industry actively seek to understand the details of cGMP regulations. In most cases, they also...
Quality control (QC) processes can be a significant bottleneck in the smooth functioning of a pharmaceutical manufacturing unit if a lot of material gets stacked into either incoming raw material or the quarantined area before it gets approved. The c...
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...
To successfully get a drug FDA approved, the data on the drug’s effects need to be reviewed by the Center for Drug Evaluation and Research (CDER), which in turn needs to determine that the drug’s benefits notably outweigh its known and potential risk...
For thousands of years, our ancestors have used the cannabis plant to treat illnesses. The medicinal use of the cannabis flower is made possible thanks to its hundreds of chemical compounds that create pleasant sensations, feelings of relief, and hea...
Tech innovations are driving the rapid evolution of everything humans do, and auditing is no exception. Since 2020, remote or virtual audits have become commonplace, born out of necessity in a time when on-site audits were simply impossible. Due to t...
Stacks of paper, what a hassle! Staying on top of who printed what, where, and when is a common struggle for many life science companies. Document reconciliation is even more of a challenge. Printing may be unavoidable, but staying compliant and keep...
Most pharma and MedTech companies have had digital transformation on their to-do list for quite some time. Unfortunately, only a few (roughly 20%) have actually pivoted from doing digital to being digital.
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