Pharma Blog
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
Oral Medication with Food versus When Fasted
Do we know there is a difference when we take medication orally with food versus when fasted? In a field known as pharmacokinetics, we measure the drug levels in blood with time. When we take medication orally, the blood drug concentration will increase to a maximum value (Cmax) at a ... Read More
Cleaning Validation | FDA vs EMA
I have reviewed 50+ cleaning validation protocols this year. And here is what still surprises me: Most companies treat FDA and EMA requirements as identical twins. They are not. The reality is: Last year, a client passed their FDA pre-approval inspection comfortably. Same facility. Same equipment. Same cleaning procedures. Three ... Read More
Differential Binding of Drug to Plasma Proteins and Tissue Proteins
Do we know that substances in blood are being transported around our body by vehicles known as ‘plasma proteins’? In a field known as pharmacokinetics, scientists study how the differential binding of drug to plasma proteins and tissue proteins defines how extensively the drug is being distributed to the bodily ... Read More
Why Vape Laced with Etomidate is Dangerous?
In brain, etomidate binds to and activate gamma-alpha butyric acid (GABA) receptor. This causes amnesia (forgetfulness), ataxia (unstable movement) and confusion. It further affects ‘wiring’ of a small part of the brain (hippocampus) and may retard brain development of young vapers. It also suppresses hormone and affects kidney and lung ... Read More
Alfentanil Interaction with Rifampin
Alfentanil is a potent, short-acting analgesic drug used for anesthesia in surgery. When alfentanil is administered to patients who were pre-treated with rifampin, an anti-tuberculosis drug, its level in our body (i.e. systemic exposure), was reduced 2- to 3-fold! A question arises: What are the rationales behind this interaction? Another ... Read More