Scilife Blog

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...

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 ...

2026 is shaping up to be a decisive year for pharmaceutical and biotech professionals. Regulatory expectations continue to tighten, innovation cycles are accelerating, and cross-functional collaboration is key. Conferences are no longer just about di...

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...