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
21 CFR Part 11 Explained: Complete Guide to FDA Electronic Records & Signatures (2026) By PharmaShare CSV Team | Data Integrity | August 2026 Quick Summary: 21 CFR Part 11 is FDA rule for accepting electronic records & signatures as equivalent to paper. Applies if you use computers in GMP/GLP/GCP. Requires Audit Trail, Electronic Signature … Read more
505(b)(2) vs ANDA: Which Filing Should You Choose? Complete Comparison 2026 By PharmaShare Regulatory Team | US FDA Pathways | August 2026 Quick Answer: ANDA is for exact copy of brand (same dose, same form). 505(b)(2) is for modified version – new strength, new form, new route, new indication. ANDA is cheap & fast ($2-5M). … Read more
