Pharma Blog
Cluster Development Program (CDP) & Data Governance
In the pharmaceutical industry, data governance is crucial for ensuring the quality, integrity, and compliance of data. The Cluster Development Program (CDP) is a framework that enables companies to implement data governance effectively. In this blog, we’ll explore why CDP and data governance are mandatory in the pharmaceutical industry and ... Read More
Re-Validation in Computerized System Validation (CSV)
In Computerized System Validation (CSV), revalidation refers to the process of re-assessing and re-qualifying a system after significant changes or events that may impact its validated state. It ensures that the system continues to operate as intended and in compliance with regulatory requirements. Revalidation is often required in the following ... Read More
Validation of a SCADA System Within CSV
Steps in SCADA (Supervisory Control and Data Acquisition) System Validation: Read also: Resource Person: Mohamed Mahmoud
Particle Size Distribution (PSD) Requirements for Different Dosage Forms
Immediate-Release Tablets Controlled-Release Tablets Oral Suspensions Inhalation Formulations Topical Creams/Ointments Injectables (Parenterals) Practical Steps for PSD Optimization Read also: Resource Person: Moinuddin Syed. Ph.D, PMP
US FDA Inspection and SMEs Role
Before Inspection During Inspection Key Phrases Best Practices Common FDA Inspection Questions After Inspection Additional Tips By following these guidelines, SMEs can effectively communicate with US FDA inspectors. Read also: Resource Person: Rajesh Jain
Legal Basis for Marketing Authorization in the EEA
Navigating the regulatory landscape for drug approval in the European Economic Area (EEA) can be complex. There are multiple legal pathways, each with its own requirements, especially around clinical studies. Here’s a quick snapshot: Full Applications (Article 8(3) of Directive 2001/83/EC) require comprehensive clinical data for new products. Generic Applications ... Read More
FDA NDA Classification Codes
Understanding New Drug Application (NDA) Classification Codes is crucial for setting clear regulatory and development timelines. These codes help the FDA categorize new drugs based on their relationship to previously approved therapies. The numerous acronyms used by the FDA, along with their distinct meanings, can be quite confusing. Beyond its ... Read More
Total Organic Carbon (TOC) | Principle, Working and Applications
Principle Total Organic Carbon (TOC) is a measure of the amount of carbon found in organic compounds in a water or soil sample. It is a key indicator used in environmental, pharmaceutical, and water quality testing. The principle behind TOC analysis involves oxidizing the organic carbon present in the sample ... Read More
Clinical Trials with Decentralized Elements
The U.S. Food and Drug Administration (FDA) issued final guidance titled “Conducting Clinical Trials with Decentralized Elements.” This guidance provides recommendations for sponsors, investigators, and other stakeholders on implementing decentralized elements in clinical trials. A decentralized clinical trial (DCT) is defined as a trial where trial-related activities occur outside traditional ... Read More
Hydrophilic and Hydrophobic Properties of Drug Substance
In pharmaceutical preparations, Hydrophobic and Hydrophilic properties play a crucial role in how drugs are formulated, delivered, and absorbed in the body. Hydrophobic Definition: Hydrophobic substances repel water and do not dissolve easily in it. They are often nonpolar molecules, like lipids or oils. Role in Pharmaceuticals Drug Solubility: Hydrophobic ... Read More
CAS (Chemical Abstracts Service)
What is the CAS chemical number? A CAS Registry Number is a unique and unambiguous identifier for a specific substance that allows clear communication and, with the help of CAS scientists, links together all available data and research about that substance. Purpose of CAS Number 01) Uniqueness CAS numbers are ... Read More