Blog
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. ...
Determining GxP Relevant Software
Determining whether a software system is GxP (Good Practice) relevant in the pharmaceutical industry involves assessing its impact on processes ...
Software Development Life Cycle in Pharmaceutical Industry
In the pharmaceutical industry, the software development life cycle (SDLC) consists of several phases that ensure the proper development, validation, ...
URS | The Foundation of CSV
The User Requirements Specification (URS) defines what the user expects from the system from a business and compliance perspective, without ...
Is Coning Always a Problem?
One of the most common myths analysts come to me with is that coning is always a problem to be ...
New Biosimilar Era | FDA’s Biggest Shift
FDA has delivered the most consequential policy change in two decades, a shift that fundamentally transforms how our industry will ...
Common Technical Document (CTD)
The Common Technical Document (CTD) is one of the most significant harmonisation achievements in global regulatory science. Before CTD, every ...
Inspection Readiness | From Audit Week to Always-On
I have lost count of how many times I have seen teams go into panic mode the week before an ...
Understanding D50 in Particle Size Distribution of API – Why It Matters!
In pharmaceutical development, Particle Size Distribution (PSD) is a critical quality attribute—especially for Active Pharmaceutical Ingredients (APIs). Among the PSD ...
API Particle Size Distribution (PSD) Matters in Generic Formulations
In generic oral solid dosage forms, API particle size distribution is not just a physical parameter—it is a critical material ...
When is a Clinical Endpoint Bioequivalence Study Required?
In the world of generic drug development, clinical endpoint bioequivalence (BE) studies come into play when traditional PK-based BE studies ...
BCS-Based Biowaiver vs. In Vivo Bioequivalence Study
When developing a generic drug for global markets, one critical decision can save months of development time and significant costs ...