Regulatory Pharma Blogs
Revised and Expanded Version of Schedule M-II on GMP Guidelines for Cosmetic Manufacturing Introduction to Schedule M-II: Good Manufacturing Practices (GMP) for Cosmetic Manufacturing Premises and Equipment Cosmetic Manufacturing: In order to ensure the safety, quality, and consistency of cosmetic products, the manufacturing processes must adhere to stringent guidelines. One of the key regulatory frameworks …
Residue on Ignition / Sulfated Ash Test Methods Residue on Ignition; The Residue on Ignition (RoI), also known as Sulfated Ash test, is a commonly used analytical procedure in the pharmaceutical and chemical industries. It measures the amount of inorganic residue remaining after the sample is heated to high temperatures in the presence of sulfuric …
Quality Control – Overview and Key Principles Quality Control Principles: Quality Control (QC) involves sampling, setting specifications, testing, as well as the organization, documentation, and release procedures. These steps ensure that necessary and relevant tests are conducted, and materials are not approved for use, nor are products released for sale or distribution, until their quality …
Premises and Equipment in EU GMP Guidelines: An In-Depth Overview Premises and Equipment: In the field of pharmaceutical manufacturing, adherence to stringent regulations ensures that products are consistently produced and controlled according to quality standards. The EU GMP (European Union Good Manufacturing Practices) guidelines for premises and equipment play a critical role in the production …
Pharmaceutical Glass Containers: An In-Depth Overview of USP General Chapter 660 Pharmaceutical Glass Containers: Pharmaceutical packaging plays a vital role in ensuring the safety, stability, and efficacy of medications. Among various packaging materials, glass is a critical choice for many pharmaceutical products. Glass containers are designed to store pharmaceuticals in a way that prevents contamination, …
Personnel – EU GMP: An In-Depth Overview Personnel in Pharmaceutical Manufacturing The EU GMP (Good Manufacturing Practice) guidelines are a crucial set of regulations in the pharmaceutical industry, designed to ensure that medicinal products, both human and veterinary, are produced to the highest standards of quality and safety. One of the core elements of these …
Outsourced Activities under EU GMP Guidelines: A Comprehensive Overview Outsourced Activities under EU GMP: In the pharmaceutical industry, compliance with Good Manufacturing Practice (GMP) standards is critical to ensuring the quality, safety, and efficacy of medicinal products. The European Union (EU) Guidelines for Good Manufacturing Practice (GMP) provide a set of rules and regulations for …
Microbiological Control Testing in the Pharmaceutical Industry: An In-depth Overview Microbiological control testing is an essential aspect of quality assurance in the pharmaceutical industry. Ensuring the microbiological safety of products and environments is crucial for maintaining the safety, efficacy, and quality of pharmaceutical products. The testing encompasses a wide variety of procedures, including environmental monitoring, …
Loss on Drying (LOD) in Pharmaceuticals: An Overview Loss on drying (LOD) is an essential analytical test used across various industries, including pharmaceuticals, food, and manufacturing. This procedure is crucial for determining the moisture content and volatile substances present in a sample. The test helps assess the amount of water and other volatile components in …
Limit Tests in Pharmaceuticals: An Overview Introduction to Limit Tests Limit tests are used in pharmaceutical analysis to determine the presence and quantity of impurities in substances. These tests are designed to check if the levels of impurities in a substance exceed acceptable limits. Impurities, when present in higher concentrations, can negatively affect the quality, …