GAMP 5 Categories, V Model and 21 CFR Part 11, EU Annex 11
What is GAMP 5? Good Automated Manufacturing Practice, Founded in 1991. International Society for Pharmaceutical Engineering (ISPE) sets the guidelines for manufacturers and the current
GAMP
Top 7 Queries Addressed: Data Integrity and CGMP Compliance
This article provides a clear insight into the significance of data integrity within the framework of current good manufacturing practice (CGMP) for pharmaceuticals, as mandated
7 Common Compliance Issues Faced by the Pharmaceutical Industry
The pharmaceutical industry is critical in safeguarding public health by researching, developing, and manufacturing life-saving drugs. However, this sector operates in a highly regulated environment
Pharma 4.0 Adoption in India: A Catalyst for Modernization in the Pharmaceutical
As the Indian pharma sector embraces digitalization and advanced technologies, several key transformations are expected: 1. Global Competitiveness:Â By going digital and incorporating Pharma 4.0, Indian
Tweaking V Model to Accelerate GMP Automation’s and Address Data Integrity Issues
A long list of data integrity warnings received by pharma companies has made them train their focus on building and fortifying their tracking mechanisms to
TOP 3 Trends Transforming Outlook of Pharmaceutical Industry In 2023
COVID-19 spurred a sense of urgency in healthcare and pharma professionals, making the entire landscape conducive to change and digital transformation. We’re at a strange
