Pharma Blog
Why is Testing into Compliance Prohibited?
“Testing into Compliance” — A Red Flag for FDA Inspectors In pharmaceutical manufacturing, data integrity is non-negotiable. Yet some companies still engage in the risky practice of testing into compliance — retesting until a passing result is found, while ignoring or discarding out-of-specification (OOS) results without proper scientific justification. This ... Read More
FDA Guidance: Computer Software Assurance
FDA just released: Computer Software Assurance for Production and Quality System Software FOREWORD What’s new in CSA? The guidance introduces a paradigm shift: Key applications: CSA vs CSV – What’s the advantage? This means more time for innovation, less time buried in paperwork, and better assurance where it counts. CSA ... Read More
Best Practices for Managing Suppliers of API Manufacturers | APIC Guidance
The Best Practices Guide for Managing Suppliers of API Manufacturers (Version 2 – March 2024) is not a new regulatory framework, but a refined and practical reference document designed to support API manufacturers in strengthening supplier oversight and ensuring consistent quality across the supply chain. Together with the Annex 2 ... Read More
Understanding the Inactive Ingredient Guide (IIG)
The Inactive Ingredient Guide (IIG) is a regulatory database published and maintained by the United States Food and Drug Administration (USFDA). It serves as a critical reference for pharmaceutical scientists, formulation developers, and regulatory affairs professionals engaged in the development and approval of drug products—particularly generic drugs submitted through the ... Read More
What Is the FDA Orange Book, and Why Should Every Formulation Scientist Understand It?
For anyone working in pharmaceutical R&D, regulatory affairs, or generic drug development, the FDA Orange Book is not just a regulatory reference—it’s a strategic tool that can significantly influence the success of your product development. Officially titled Approved Drug Products with Therapeutic Equivalence Evaluations, the Orange Book is published by ... Read More
Selection of Reference Product Across Different Regulatory Markets
Selecting the appropriate reference product is a key step in generic drug development. It serves as the basis for bioequivalence studies and regulatory submissions. The definition and selection criteria for a reference product vary by region, as outlined below. 1. United States (USFDA) – Reference Listed Drug (RLD) The USFDA ... Read More
Is f₂ in Multimedia a True Indicator of Bioequivalence?
The f₂ similarity factor is a commonly used mathematical tool in pharmaceutical development to compare the dissolution profiles of a test product and its reference listed drug (RLD). When the calculated f₂ value is ≥ 50, it indicates that the two profiles are similar under the tested conditions. Regulatory agencies ... Read More
R&D Guide to Dissolution Specification Setting
Setting dissolution specifications at the R&D stage is a critical step in pharmaceutical product development. It ensures that the formulation will consistently meet performance expectations and regulatory requirements. Here’s a clear step-by-step guide: How to Set Dissolution Specifications in R&D 1. Understand the Role of Dissolution Dissolution testing predicts how ... Read More
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