Computerized System Validation (CSV) is the process of ensuring that a computerized system used in a GxP environment performs accurately, consistently, and reliably according to its intended purpose. Reference: FDA — General Principles of Software Validation (GPSV) CSV ensures that systems support product quality, patient safety, and data integrity, and that all electronic records and…
1. Introduction 2. Historical Context and Regulatory Push 3. Understanding the Three Pillars 3.1 Quality by Design (QbD) – The Framework Key Concepts: Stages of Application: Regulatory Basis: ICH Q8(R2), Q9, Q10, Q11, Q12, Q13, Q14. Tools: Risk assessments (FMEA, Ishikawa, Fault Tree Analysis), control strategy design. Case Study Example: QbD applied to controlled-release tablet…
Concepts Link: CMAs of the API directly affect CQAs of the injectable product. Key CMAs of API for Injectables Key CQAs of Injectable Products CMA → CQA Link Example – Corticosteroid Depot Injection Takeaway Read also: Resource Person: Moinuddin Syed. Ph.D, PMP®
A Practical Tool in Matrix-Based SR Product DevelopmentIn sustained-release (SR) oral dosage forms, drug release is often controlled by polymeric matrices—especially hydrophilic polymers like HPMC or hydrophobic ones like ethyl cellulose. One critical but often underappreciated factor that governs the release kinetics is the viscosity of the hydrated matrix system. The gel layer viscosity plays…
In sustained-release (SR) or extended-release (ER) formulations, the relationship between Tmax, Cmax, and dissolution specification time points is critical to ensure the product delivers the drug at a controlled rate, maintaining therapeutic levels over an extended period. Unlike immediate-release formulations where the goal is rapid absorption and a quick Tmax, SR products are designed to…
What is IVIVC? BCS and IVIVC Feasibility Types of IVIVC Steps to Develop Level A IVIVC for SR Products Regulatory Validation Criteria If met, the IVIVC model can support biowaivers and post-approval changes without further clinical studies. Best Practices for Dissolution Testing in SR IVIVC Applications of IVIVC in SR Development Common Challenges in SR…
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