Pharma Blog
How to Set Impurity Limits in Drug Products
Step-1: Classify the peak by origin Step-2: Map the dominant formation pathway and whether it’s avoidable Amlodipine besylate tablets example: Step-3: Apply the correct regulatory ruleset + exposure thresholds Step-4: Convert limits into analytical requirements Step-5: Link each limit to control level (control strategy) Related: Pharmaceutical Impurities Calculator Resource Person: Pearl Pereira ... Read More
Safe Impurity Limit for Pharmaceuticals
The fastest way to sabotage your own submission? Set impurity limits to “look safe” Both sides think they’re protecting the product. Sometimes both are wrong! Here’s what actually happens: Set the limit too tight – based on early data: What started as a ‘conservative’ decision now stretches your development timeline. ... Read More
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
GAMP 5 System Lifecycle: From Concept to Retirement
Concept Phase — Understanding the Need The lifecycle starts with identifying why the system is needed and how it will support a GxP process. Key activities: Project Planning & Specification This phase transforms user needs into clear, testable requirements. Deliverables include: System Development & Configuration Depending on the system category ... Read More
Global Product Development | Key Steps and Common Mistakes
1. Product Identification & Target Market Definition Steps: Common Mistakes: 2. API and Excipient Selection Steps: Common Mistakes: 3. Formulation Development Steps: Common Mistakes: 4. Analytical Development Steps: Common Mistakes: 5. Stability and Compatibility Studies Steps: Common Mistakes: 6. Process Optimization and Scale-Up Steps: Common Mistakes: 7. Bioequivalence and Clinical ... Read More
Multiple Peak Plasma Concentrations (Cmax) of Drugs
There are several potential reasons for multiple peak plasma concentrations. One of which is gut-liver (enterohepatic) recycling (EHR) of drugs. Why is this EHR important for our health? It explains why our gut health (i.e. gut bacteria) can affect drug handling in our body and its treatment (therapeutic) effect. Read ... Read More