Pharma Digest
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
Necessity of Thorough Deviation and Complaint Investigations
One of the most frequently cited issues during FDA inspections pertains to the failure to conduct thorough investigations regarding unexplained discrepancies. Once an investigation is conducted and findings are documented, 21 CFR 211.192 emphasizes the necessity of implementing follow-up actions to prevent the recurrence of discrepancies or product failures. Companies ... Read More
Mock FDA Inspections for Cleaning Validation
Cleaning validation is a crucial aspect of pharmaceutical manufacturing that ensures the removal of product residues, cleaning agents, and contaminants from manufacturing equipment. Inadequate cleaning can lead to product contamination, cross-contamination, and reduced product quality. Scope of FDA Warning Trend = In fiscal year 2023, the FDA issued 180 warning ... Read More
Understanding the FDA 483 Warning Letter
FDA Form 483 = Official notification issued at the conclusion of a facility inspection when FDA investigators identify conditions that may violate the FD&C Act and related regulations. Consists of observations regarding practices that may lead to the adulteration of products or pose health risks. Navigating the FDA 483 Warning ... Read More
Understanding Stratified Sampling in Pharmaceutical Industry
FDA recommends the necessity of statistically sound sampling plans [Intra-Location (within a single location) Variability and Inter-Location (between locations) Variability] and acceptance criteria [acceptable range of deviation from the mean content, the variability of measurements, and the percentage of units falling within predetermined limits is based on statistical principles] to ... Read More
Process Validation | The Foundation of Quality Products
Process Validation Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product ... Read More