Pharma Digest
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
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
Cetylpyridinium Chloride (CPC) in Dissolution Bath
Cetylpyridinium chloride (CPC) at 0.01% w/v is often used in a dissolution bath to maintain microbial control and ensure the cleanliness of the system. Its inclusion helps prevent microbial contamination, which could interfere with the dissolution process and affect the accuracy of drug release studies. CPC is a cationic surfactant ... Read More
Differences Between eCTD and ACTD Dossier
eCTD (Electronic Common Technical Document) ACTD (ASEAN Common Technical Dossier) Key Differences Read also: Resource Person: KABYA PRATAP ROYAL
How to Handle CSV in Pharmaceutical Industry
In the pharmaceutical industry, quality is not just an expectation; it’s a regulatory requirement. Computer System Validation (CSV) plays a critical role in ensuring that systems used to manage data and automate processes meet the necessary standards. For QA (Quality Assurance) professionals, overseeing CSV is essential for maintaining compliance and ... Read More