Blog
Normality (N)
Normality (N) in Chemistry: Normality (N) is a measure of concentration in chemistry that expresses the number of equivalents of ...
Assay vs Potency | Understanding the Critical Differences
ASSAY An assay measures the quantity or concentration of a drug’s active ingredient, typically expressed as a percentage or mg/mL. ...
Good Manufacturing Practice (GMP)
This regulations ensuring the quality and safety of products like pharmaceuticals, food, and cosmetics. This refers to a system of ...
Purple Book vs Orange Book
Purple Book The Purple book is a list of biological products, including biosimilars and interchangeable biological products, approved or licensed ...
Purified Water vs. Deionized Water
Purified Water (PW) and Deionized Water (DI Water) are related but not exactly the same, although Deionized Water can be ...
QC vs. QA
Quality Control (QC) and Quality Assurance (QA) are two essential components of quality management, but they serve different purposes and ...
Sterilization vs. Depyrogenation
Sterile pharmaceutical manufacturing demands absolute control over microbial and endotoxin contamination. Two essential processes ensure product safety—sterilization and depyrogenation. While ...
Key Parts of 21 CFR
21 CFR refers to Title 21 of the Code of Federal Regulations, which contains regulations related to food and drugs ...
Regulatory CMC Comparison | US vs. EU Market
Understanding the regulatory requirements for Chemistry, Manufacturing, and Controls (CMC) is crucial for global product success. Here’s a quick comparison ...
Regulatory Affairs A-Z | The Compliance Alphabet
A – ANDA (Abbreviated New Drug Application) – The golden ticket to launch a generic drug in the US—only if ...