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
What is 180-Day Exclusivity in US? The $100 Million Prize for First Generic By PharmaShare Regulatory Team | US FDA Generic Strategy | August 2026 Quick Answer: 180-Day Exclusivity is a 6-month monopoly given by USFDA to the First Company that files an ANDA with Para IV challenge and wins. For those 180 days, FDA … Read more
What is Orange Book & How to Read It? Complete Guide for Generic Pharma By PharmaShare Regulatory Team | US FDA Regulatory | August 2026 Quick Answer: Orange Book is the FDA’s official list of all approved drugs + their patents + exclusivity + generic equivalents. If you work in Regulatory, R&D, IP or Business … Read more
Types of ANDA Filing in the US: Para I, II, III, IV Explained with Examples By PharmaShare Regulatory Team | US FDA Regulatory Affairs | August 2026 Quick Answer: An ANDA can be filed under 4 Paragraph Certifications (I, II, III, IV). Your Para filing decides if you launch immediately, wait for patent expiry, or … Read more
