Overview of Various National Filing Terminologies: Regulated vs Emerging Markets – US, EU, Japan, Brazil, Tanzania, Russia, Hong Kong Quick Summary: Pharmaceutical industry is one of the most highly regulated industries to protect health of masses. While world regulations are harmonizing, they can be divided into 4 major categories – North America (US, Canada), Europe … Read more
Regulatory Filing in Pharma: How to Develop One Drug for Global Markets – US, EU, and ROW Quick Summary: Regulatory requirements of various countries vary. It is challenging to develop a single drug which can be simultaneously submitted in all countries. So regulatory strategy must be fixed BEFORE development starts, otherwise you will get major … Read more
QbD Elements in Pharma: QTPP, CQA, CMA, CPP, and Control Strategy Explained Practically Quick Summary: QbD is not theory. It has 5 clear elements. First we define QTPP – what quality we want for patient. From QTPP we derive CQA – what must be controlled. Then we find CMA (material) and CPP (process) that impact … Read more
Process Analytical Technology (PAT) Techniques: How to Move From Testing Quality to Building Quality in Real-Time Quick Summary: PAT is process analysis in real-time. Instead of taking sample to lab and waiting 2 days for result, PAT measures quality during manufacturing itself. It is a shift from product-centric testing to process-centric understanding. At-line, on-line, in-line … Read more
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
GAMP 5 in Pharma – What It Really Is, Why FDA Loves It & How to Implement It Practically My Quick Take: GAMP 5 is not a regulation. It’s a guideline – a guidebook written by ISPE to help us validate computerized systems in a simple, risk-based way. If 21 CFR Part 11 tells you … Read more
Role of Dust/Oil Seals in Turret of Tablet Compression Machine: Types, Function, Failure & Prevention Quick Answer: Dust/oil seals in turret are critical PTFE/NBR/PU seals fitted on upper and lower punch bores in turret to prevent 2 things: 1. Dust Seal – Stops granule powder from entering turret guide & lubrication area, 2. Oil Seal … Read more
Empty Capsule Sorter in Capsule Filling Activity: Working, Types, Qualification & Troubleshooting Quick Answer: Empty capsule sorter (also called capsule rectifying unit or loose cap/body separator) is a pre-filling unit that removes loose caps, loose bodies, unseparated capsules, double caps and broken capsules from bulk empty capsules before they go to capsule filling machine. Without … Read more
AWC System in Tablet Compression Machine: Principle, Working, Calibration & Troubleshooting Quick Answer: AWC (Auto Weight Control) is an automatic closed-loop system in modern rotary tablet presses (Fette, Korsch, Cadmach) that maintains uniform tablet weight. It checks individual tablet weight via load cell/checkmaster and automatically adjusts lower punch fill depth via dosing cam or air … Read more
Determination of Expiry Date in Pharma Oral Dosage Forms: Stability, ICH Guidelines & Shelf-Life Calculation (2026 Guide) Quick Summary: Expiry date of oral dosage forms (tablets, capsules, syrups) is determined by stability studies per ICH Q1A(R2). Shelf-life is assigned based on real-time long-term data where the drug remains within 90-110% assay, no significant change in … Read more
