Good Manufacturing Practices (GMPs) have been the cornerstone of quality assurance in pharmaceuticals and medical devices for decades. These guidelines ensure that every product, from medicines to medical devices, is consistently produced and control...
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...
In GxP-regulated sectors like pharma, biotech, and medtech, computerized systems play a key role in ensuring patient safety, data traceability, regulatory compliance, and integrity. Many regulations and guidelines have been developed to validate such...
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).
GxP-compliance Software as a Service (SaaS) is becoming increasingly popular owing to its flexibility and ease of use.
In GxP-compliant environments, the importance of having a skilled and reliable workforce cannot be overstated. Maintaining employee training and competence records is not a choice but a mandate in the highly regulated Life Sciences industry.
Subscribe to the
Scilife Blog
Life Science and Quality resources and news. All directly to your inbox!
