Latest Pharma Topics

What is a Non-GxP System?

What is a Non-GxP System?

Non-GxP systems do not affect product quality, patient safety, or regulatory decisions. Validation effort here is minimal or not required. Examples: Reference: ISPE GAMP 5 — Appendix M4 (System Categorization). … Read More

Determining GxP Relevant Software

Software Development Life Cycle in Pharmaceutical Industry

URS | The Foundation of CSV

Is Coning Always a Problem?

New Biosimilar Era | FDA’s Biggest Shift

Trending Pharma Topics

Common Technical Document (CTD)

Inspection Readiness | From Audit Week to Always-On

Understanding D50 in Particle Size Distribution of API – Why It Matters!

API Particle Size Distribution (PSD) Matters in Generic Formulations

When is a Clinical Endpoint Bioequivalence Study Required?

BCS-Based Biowaiver vs. In Vivo Bioequivalence Study

Featured Pharma Topics

NME vs. NCE | Understanding the Difference in Drug Development

Regulatory CMC Comparison | US vs. EU Market

Regulatory Affairs A-Z | The Compliance Alphabet

Site Master File (SMF)

Letter of Authorization (LOA)

Marketing Authorization Holder (MAH)

Understanding CEP, DMF, CADIFA and ASMF

Post-Approval Changes in Pharmaceutical Industry

Key Aspects of SUPAC Guidelines

Quality by Design (QbD)

ALCOA+ Principles in Pharmaceutical Indusrty

Why Distilled Water is Commonly Used in QC Testing?

The f2 Similarity Factor in Dissolution

Types of Standard Solution

Molality (m)

Molarity (M)

Normality (N)

Assay vs Potency | Understanding the Critical Differences

QC vs. QA

Certificate of Analysis (COA)

Half-life vs Shelf life vs Expiry Date

Why Do Syrups Expire Faster Than Tablets?

Why Do We Check Disintegration Time (DT) in Acidic and Buffer Media?

Various Statistical Methods in Pharma | A Key to Data-Driven Decisions

Types of Water in Pharmaceutical Industry

Purple Book vs Orange Book

Purified Water vs. Deionized Water

Key Parts of 21 CFR

Overall Equipment Effectiveness

Exhibit Batches in Pharmaceutical Industry

Featured Sections

Pharmacy Certification Courses