Manufacturing Automation

Ever feel like managing batch records is more about paperwork than actual production? You’re not alone. In pharmaceutical manufacturing, batch documentation is essential — but it can be time-consuming, error-prone, and downright frustrating.  That’s where AI in eBMR steps in.  What AI Brings to the Table  Artificial Intelligence is slowly becoming a game-changer in the […]

A Near-Miss That Changed an Industry  In 2008, a major recall of heparin—a life-saving blood thinner—sent shockwaves through the pharma industry. Contaminated raw materials had slipped through quality checks, endangering thousands. This disaster highlighted a critical need: proactive risk management.  Enter ICH Q9 in pharma—a game-changing framework that shifts manufacturers from reactive fixes to predictive […]

The Silent Guardians of Drug Quality  Imagine a world where every pill, vaccine, or injection you take could vary in strength, purity, or safety. Scary, right? Fortunately, Good Manufacturing Practices (GMP) in pharma act as the invisible shield ensuring that every medicine meets strict quality standards before reaching patients.  GMP isn’t just a regulatory checkbox—it’s […]

The Rising FDA Scrutiny of eBMR Systems In recent FDA inspections, over 60% of 483 observations in pharma manufacturing cited electronic batch record (eBMR) failures—from missing audit trails to unchecked overrides. These findings delay approvals and cost millions in remediation. This blog reveals:  Top 5 eBMR-related 483 observations (based on FDA public data)  Proven fixes […]

Pharmaceutical manufacturers must adhere to stringent regulations to ensure product safety, efficacy, and quality. Two key regulatory frameworks that guide Good Manufacturing Practices (GMP) are Schedule M (India) and WHO GMP (World Health Organization). While both focus on ensuring high-quality pharmaceutical production, they have distinct requirements and global implications. This blog explores the differences between […]

In pharmaceutical manufacturing, compliance with regulatory standards is critical to ensuring product quality, safety, and traceability. ISA 88, also known as the Batch Control Standard, plays a key role in streamlining batch processing while aligning with regulatory frameworks like FDA regulations, Good Manufacturing Practices (GMP), and 21 CFR Part 11. This article explores how ISA […]

In pharmaceutical manufacturing, precision and compliance are non-negotiable. But have you ever thought of stage labeling as more than just a compliance measure? When done right, stage labeling is a powerful tool to enhance quality, productivity, and material traceability across your operations.  Here’s how stage labeling best practices can transform your manufacturing processes, ensuring accuracy, […]

In pharmaceutical manufacturing, precision and efficiency are paramount. With the increasing complexity of production processes, it’s essential to have systems in place that ensure everything runs smoothly and in compliance with industry standards. This is where SCADA (Supervisory Control and Data Acquisition) comes into play.  But what exactly is SCADA, and how does it help […]

Maintaining process robustness is crucial for quality, compliance, and efficiency in pharmaceutical manufacturing. But how can you ensure your processes run smoothly always? One of the most powerful tools is intelligent data logging and monitoring.  Gone are the days of relying solely on manual logs and outdated systems. With the evolution of technology, pharma manufacturers […]