Pharma Quality Agreements: What to Include (Sponsor vs CDMO)
Learn what must be included in a pharma quality agreement. This guide covers key clauses, sponsor vs. CDMO responsibilities, and GMP regulatory requirements fro
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Articles tagged with “pharmaceutical-manufacturing”
PAT Sensors for Real-Time Reaction Monitoring in Pharma
Learn how Process Analytical Technology (PAT) uses sensors like NIR & Raman for real-time reaction monitoring in pharmaceutical manufacturing to improve quality
Quality by Design (QbD) & PAT in Pharma Manufacturing
Learn how Quality by Design (QbD) and IT systems are shifting pharma from end-product testing to real-time quality assurance with PAT and data analytics.
IBP & S&OP for Pharma Supply Chains: A Practical Guide
Learn how Integrated Business Planning (IBP) and S&OP help pharma supply chains align demand, capacity, inventory, and constraints to improve forecast accuracy.
AI/ML Validation in GxP: A Guide to GAMP 5 Appendix D11
Learn to validate AI/ML systems in GxP manufacturing using the GAMP 5 Appendix D11 framework. Explore key considerations for data integrity, risk, and model dri
Quality 4.0 in Pharma: A 2026 ROI & Economic Analysis
Explore a 2026 ROI analysis of Quality 4.0 in pharma manufacturing. Learn how technologies like AI & digital twins drive up to 45% cost savings and 40% capacity
Machine Learning for CMC Process Optimization: A Guide
Learn how machine learning (ML) and AI are used for pharmaceutical CMC process optimization. This guide covers applications, data challenges, and case studies.
In-Demand Pharma Roles: AI, Manufacturing & Clinical Jobs
Learn about the most in-demand pharma roles for 2025. This analysis covers top pharmaceutical jobs in AI, advanced manufacturing, and clinical development.
New Drug Manufacturing Plants: A 2025 Guide & Analysis
An analysis of the 2025 surge in new drug manufacturing plants from Eli Lilly, AstraZeneca & more. Learn about the key drivers: supply chain & geopolitics.
Understanding GAMP 5 Guidelines for System Validation
An overview of GAMP 5 guidelines for validating computerized systems. Explains the risk-based approach, system lifecycle, and updates for AI and cloud tech.
Evaluating ERP Systems for Pharmaceutical Compliance
An analysis of top ERP systems for the pharmaceutical sector, evaluated on regulatory compliance (21 CFR Part 11), batch traceability, and serialization.
NetSuite ERP Modules for Pharma Labs: GMP, FDA Compliance
Learn how NetSuite ERP modules support U.S. pharmaceutical manufacturing labs, covering GMP, FDA (21 CFR Part 11) compliance, and integrations for quality and production.
Computer Vision in Pharmaceutical Quality Control: Vendors, Applications, and Trends
Explore how AI-powered computer vision is transforming pharmaceutical quality control. Review top vendors, applications, and trends in pharma QC automation.