Formulation Development
API Particle Size Distribution (PSD) Matters in Generic Formulations
Chief Pharmacist
In generic oral solid dosage forms, API particle size distribution is not just a physical parameter—it is a critical material ...
Lean Six Sigma and QbD
Chief Pharmacist
Quality by Design (QbD) is a science- and risk-based approach outlined in ICH Q8, Q9, and Q10. It emphasizes that ...
Relationship Between QTPP and CQA
Chief Pharmacist
Introduction In QbD) the development of a pharmaceutical product starts with understanding the patient and therapeutic needs. These needs are ...
Quality Target Product Profile (QTPP) in Pharmaceutical Development
Chief Pharmacist
The Quality Target Product Profile (QTPP) is a prospective summary of the key quality characteristics that a drug product should ...
Lean Six Sigma in Pharmaceutical Formulation Development – A Practical Perspective
Chief Pharmacist
In today’s competitive pharmaceutical environment, cost optimization, regulatory compliance, and speed to market are critical success factors. While Quality by ...