Pharma Digest
Dissolution Method Validation Across Multiple Strengths
Last week I came across a LinkedIn post claiming you can validate one ‘pseudo/ worst-case strength’ because same API = same method performance. While it’s true that ‘representative’ strengths ARE used in method validation. But for dissolution, this assumption is an oversimplification to the point where it’s not correct. Why? ... Read More
Stabilizing a Pharmaceutical Formulation through Packaging
In pharmaceutical development, formulation stability is often discussed only in terms of excipient selection and process optimization. However, in real-world product development, stability is achieved through an integrated approach involving formulation, process, and packaging together. Packaging is not merely a container. It is a functional component of the drug product ... Read More
End-to-End DoE Implementation Framework
1. Define the ObjectiveEvery DoE must start with a clearly defined objective. This answers the fundamental question: Why are we doing this experiment?Typical objectives include identifying critical factors, optimizing a formulation or process, or resolving a specific quality or performance issue. A weak objective leads to weak learning. 2. Identify ... Read More
Developing an Effective Control Strategy within a QbD Framework
Quality by Design is not about documentation. It is about understanding how materials and processes influence product quality and patient safety. The pharmaceutical control strategy develops step by step, as outlined below: I. Identification of Critical Material Attributes (CMAs) CMAs are physical or functional properties of raw materials that can ... Read More
Types of Variation Filings in UK and Europe
In pharmaceutical regulatory affairs, product life does not end with approval. Every post-approval change must be scientifically justified and filed through a defined regulatory pathway. These post-approval submissions are known as Variation Filings, and both the European Union and the United Kingdom follow structured classification systems to manage them. In ... Read More
ICH Q9 (Quality Risk Management) | Moving from Compliance to Scientific Decision-Making
In pharmaceutical development and manufacturing, not every issue carries the same level of risk. ICH Q9 was introduced to bring structure, science, and proportionality into how quality decisions are made. At its core, ICH Q9 defines QRM as a systematic process for the assessment, control, communication, and review of risks ... Read More
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