Scilife Blog

It is now well known by the Life Sciences community that the new version of EU GMP Annex 1, which was issued on 22nd August 2022, will come into force on 25 August 2023 (with the exception of chapter 8.123 "Product transfer/loading/unloading areas fo...

If you have ever sat through an FDA inspection, you know the atmosphere. It is quiet, tense, and strangely similar to watching someone test a structure you built with your own hands. You might feel confident in your SOPs, your training records, and y...

A robust laboratory quality management system is essential in medical research laboratories to ensure the integrity and reliability of the tests conducted. Implementing a laboratory quality management system can be an overwhelming task, but organizat...

What is Pharma 4.0? Pharma 4.0 is the trademark of an initiative from the International Society for Pharmaceutical engineering (ISPE). Pharma 4.0 refers to the use of Industry 4.0, also called Smart Factory technologies, to improve quality and effici...

The European Medicine Agency’s (EMA’s) 3-year “Work Plan” for the Quality Domain is a strategic roadmap set by the Good Manufacturing and Distribution Practice (GMDP) Inspectors Working Group (IWG).

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 ...

2025 brings new opportunities to discover future advancements in pharmaceuticals and biotechnology and connect with other professionals and opportunities. Here are some of the key events and conferences being held this year.

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...