Knowledge of Quality by Design (QbD) in Pharma: From Concept to Design Space & Control Strategy Quick Summary: You can’t test quality into drug products. Quality should be built in by design. That’s the core of QbD. In this blog, I will explain QbD in simple language – What is QbD, why ICH Q8, Q9, … Read more
In-Use Stability Study for Solid Oral Dosage Forms in Pharma: Complete Guide In-Use Stability Study for Solid Oral Dosage Forms in Pharma: A Complete Guide In-use stability studies are an important component of pharmaceutical stability programs when a medicinal product may be stored, handled, opened, exposed to environmental conditions, or repeatedly accessed during its period … Read more
Qualitative Risk Assessment in Pharma: Complete Guide to QRM, ICH Q9(R1), Risk Matrix & Examples (2026) Qualitative Risk Assessment in Pharma: Complete Guide to Quality Risk Management (ICH Q9(R1)) Every pharmaceutical process carries some degree of risk. Whether manufacturing tablets, qualifying equipment, validating a cleaning process, implementing a change control, or investigating a deviation, organizations … Read more
CAPA and CAPA Effectiveness in Pharmaceutical Industry CAPA and CAPA Effectiveness in the Pharmaceutical Industry “CAPA Process in Pharmaceutical Quality Management System” Corrective and Preventive Action (CAPA) is one of the most critical elements of a Pharmaceutical Quality System (PQS). Regulatory agencies worldwide, including the FDA, EMA, MHRA, and WHO, expect pharmaceutical manufacturers to establish … Read more
FMEA Application in Pharma | ICH Q9 R1 Risk Management Guide + Template 2026 Application of FMEA Tool in Pharma Risk Management: Complete ICH Q9 R1 Guide 2026 Published: April 19, 2026 | Category: Quality Risk Management | Reading Time: 8 min Failure Mode and Effects Analysis = FMEA. It’s the first QRM tool USFDA … Read more
Risk Management in Pharma: ICH Q9 R1 Guide + 7 QRM Tools 2026 Quality Risk Management QRM is no longer optional in pharma. ICH Q9 R1 makes it mandatory across product lifecycle – from development to commercial manufacturing. But 80% of QA teams still do risk assessment as “copy-paste” exercise. Result: USFDA 483 for “Risk … Read more
