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...
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. ...
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...
GxP-compliant Software as a Service (SaaS) term is becoming increasingly popular owing to its flexibility and ease of use. SaaS is a web-based service as it uses the internet to conveniently make software available for direct use to its clients. SaaS...
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.
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