Pharma Digests
Anatomy of an FDA Inspection | Part 2 of 2
Winning the Inspection Game – The Habits of Inspection-Ready Companies LIVE THE CULTURE: The entire organization, from top management to line operators, knows that quality isn’t a department—it’s a mindset. It’s part of the air you breathe, the decisions you make. Follow SOPs consistently, encourage employees to report and fix ... Read More
Anatomy of an FDA Inspection | Part 1 of 2
Inspections are how the FDA checks that what’s promised is real: FDA inspections can occur for various reasons – a routine schedule, a follow-up to a prior issue, a pre-approval for a new product, or “for-cause” in response to a specific problem. What Happens During an FDA Inspection? (And What ... Read More
How Are Nitrosamine Impurities Generated in Pharmaceuticals?
Nitrosamines are formed through specific chemical reactions during drug manufacturing or storage. These impurities have become a major focus for regulatory bodies due to their potential health risks. Here’s how they are generated: 1. Reaction Between Nitrites and Amines: 2. Use of Nitrosating Agents in Manufacturing: 3. API Degradation: 4. ... Read More
Can You Crush a Tablet Before Taking It?
Whether it’s for your grandma who can’t swallow, or your child who hates medicine… many of us have crushed tablets thinking it’s harmless. But did you know? Not every tablet is made for that. Let’s break it down simply: Tablets You Should NEVER Crush: 1. Enteric-Coated Tablets (EC) 2. Extended-Release ... Read More
Can You Store Tablets in the Fridge?
Short Answer: No, unless the label or pharmacist says so. Why You Shouldn’t Refrigerate Tablets? 1. Condensation = Killer 2. Not Designed for Cold 3. Packaging Breakdown When Fridge Is Okay for Medicines? Only store in the fridge if the label or pharmacist clearly says: “Store at 2–8°C” Examples: Insulin, ... Read More
Blister Pack vs. Bottle | The Real Reason Behind Packaging Choices
Ever wondered why some medicines come in blisters while others are in bottles? It’s not just about cost or convenience—there’s a lot more behind these decisions! 1. RLD (Reference Listed Drug) – The Hidden Decision Maker When a generic drug is developed, it must match the Reference Listed Drug (RLD), ... Read More
Glomerulonephritis (GN)
Glomerulonephritis (GN) is a group of kidney diseases that involve inflammation of the glomeruli, which are the filtering units of the kidneys. Here are some key points about GN: Types of Glomerulonephritis: 1. Acute glomerulonephritis: Sudden onset of inflammation and damage to the glomeruli. 2. Chronic glomerulonephritis: Long-term inflammation and ... Read More
All About Kidneys
Anatomy and Structure Location: Kidneys are located on either side of the spine, just below the ribcage, in the retroperitoneal space. Shape and Size: Each kidney is bean-shaped, typically about 10-12 cm. Components: Functions of the Kidneys Filtration: Regulation of Homeostasis: Hormone Production: Blood Pressure Regulation: Detoxification: Diagnostic Tools Blood ... Read More
Incisions of Abdominal Surgery
1. Midline Incision 2. Paramedian Incision 3. Transverse Incision 4. Kocher Incision 5. McBurney Incision 6. Lanz Incision 7. Pfannenstiel Incision 8. Battle’s Incision 9. Rutherford-Morrison Incision These incisions are selected based on factors such as: Read also: Resource Person: Akmal K. Ishak
DNA Extraction Process
DNA extraction is more than just a lab technique; it’s a process rooted in biochemistry and molecular biology principles. 1. DNA extraction A process of isolating DNA from cells or tissues to study its structure, sequence, or function. This process involves breaking open cells, separating DNA from other cellular components, ... Read More
Ways to Extend the Lifespan of C18 Columns & Guard Columns
Use a Guard Column Filter and Degas Mobile Phase Use Proper pH and Buffer Conditions Regular Column Flushing Avoid Prolonged Exposure to Aqueous Buffers Inject Clean Samples Optimize Flow Rate and Pressure General Precautions Before Cleaning Initial Rinse (Removing Buffer and Salts) Purpose: To remove any buffer salts that may ... Read More