Regulatory Pharma Blogs
EU GMP Guidelines for Documentation EU GMP Guidelines: The European Union (EU) Good Manufacturing Practice (GMP) guidelines for medicinal products are a comprehensive set of regulations that ensures the consistent production of high-quality pharmaceuticals. These guidelines cover a wide range of processes and practices within the pharmaceutical industry, with one of the critical components being …
Dissolution Test in Pharmaceutical Quality Control Introduction to the Dissolution Test Dissolution Test: A dissolution test is an essential procedure in pharmaceutical quality control used to evaluate how quickly and effectively a solid dosage form, such as a tablet or capsule, dissolves in a specified liquid medium. This test simulates the conditions of the human …
Disintegration Test: Overview and Procedures Disintegration Test: The disintegration test is a critical procedure used in pharmaceutical quality control to assess the ability of solid dosage forms—such as tablets and capsules—to break down into smaller particles when exposed to a liquid medium. This test ensures that the medication can disintegrate in the digestive system, allowing …
Data Integrity in the Pharmaceutical Industry: Understanding ALCOA+ Principles Data integrity is a critical concept in many industries, particularly in sectors like pharmaceuticals, where maintaining the accuracy, reliability, and consistency of data is essential. The process of managing data in the pharmaceutical sector not only involves ensuring that the data is correct but also that …
Comprehensive Guide to HPLC Troubleshooting: Common Problems, Causes, and Solutions HPLC: High-Performance Liquid Chromatography (HPLC) is a sophisticated analytical technique used for separating, identifying, and quantifying compounds in a mixture. Given its complexity, maintaining an optimal system performance and troubleshooting any issues that arise during analysis is crucial. This guide will walk you through pre-analysis …
Bursting Strength Testers: Essential Instruments for Material Evaluation in Packaging Industry Bursting Strength Testers: In the packaging and manufacturing industries, quality control is a fundamental part of ensuring that products are durable and able to withstand the challenges of transportation and handling. Among the various tests used to assess the reliability and strength of materials, …
Aseptic Processing in Pharmaceutical Manufacturing: A Comprehensive Overview Aseptic processing is a crucial method used in the pharmaceutical industry to ensure the sterility of certain products. In this process, products that require sterility for safe and effective use, such as injections, ophthalmic preparations, irrigating solutions, and hemodialysis solutions, are handled and processed to prevent microbial …
21 CFR Part 211: Current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals 21 CFR Part 211: The US Food and Drug Administration (FDA) sets standards to ensure the quality of pharmaceutical products through its regulations, particularly 21 CFR Part 211, which details the Current Good Manufacturing Practices (cGMP) that drug manufacturers must adhere to. These …
Understanding the Transparency Tester: An Essential Tool for Testing Gelatin Capsules and Products Transparency Tester: In the world of pharmaceutical and food industries, quality control and standards are paramount. One of the key tests to ensure that gelatin capsules or other gelatin-based products meet the required transparency standards is the use of a transparency tester. …
Understanding Tablet Thickness and Its Importance in Pharmaceutical Quality Control What is Tablet Thickness? Tablet thickness refers to the distance measured through the center of a tablet from one surface to the other. This dimension is one of the critical aspects in tablet formulation, production, and packaging. A tablet’s thickness affects several factors, including its …