Regulatory Pharma Blogs
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, …
Karl Fischer Titration: A Detailed Overview Karl Fischer Titration (KFT) is an analytical technique used primarily for the precise determination of water content in various substances. This method is vital in pharmaceutical, food, and chemical industries, where moisture content is a critical parameter for the quality of the product. The titration is based on a …
Introduction to International Council for Harmonisation (ICH) Guidelines International Council for Harmonisation: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an organization focused on creating guidelines to foster the global harmonization of pharmaceutical development. ICH collaborates with regulatory authorities and the pharmaceutical industry to develop consensual standards for …
High Performance Liquid Chromatography (HPLC): An In-Depth Overview High Performance Liquid Chromatography (HPLC) is a vital analytical technique used to separate, identify, and quantify components within a mixture. As one of the most advanced and efficient forms of chromatography, HPLC plays a crucial role in various industries such as pharmaceuticals, food safety, clinical research, environmental …
Good Manufacturing Practices (GMP) for Oral Solid Dosage Forms (Tablets and Capsules) under Schedule M – Part 2 (OSD) Introduction to GMP for Oral Solid Dosage Forms Oral Solid Dosage Forms: The manufacturing of oral solid dosage forms (OSD), such as tablets and capsules, requires stringent adherence to Good Manufacturing Practices (GMP) as outlined in …
Good Manufacturing Practices for Sterile Products, Parenteral Preparations (Small Volume Injectables and Large Volume Parenterals) and Sterile Ophthalmic Preparations Sterile Products: The manufacture of sterile products, parenteral preparations, and sterile ophthalmic preparations requires adherence to stringent standards. As outlined in Schedule M – GMP Part 1, which covers premises and materials for pharmaceutical products, these …
Good Manufacturing Practices (GMP) and Requirements for Premises, Plant, and Equipment for Homoeopathic Medicines Homoeopathic Medicines: The production of homoeopathic medicines involves strict regulations and standards to ensure the quality, safety, and efficacy of the products. One of the key sets of guidelines governing the manufacturing process is the Good Manufacturing Practices (GMP), which provide …
Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients (API) – Bulk Drugs: A Comprehensive Overview Active Pharmaceutical Ingredients: In pharmaceutical manufacturing, ensuring the highest standards of quality and safety is paramount. The Good Manufacturing Practices (GMP) guidelines serve as the framework for ensuring that pharmaceutical products are consistently produced and controlled according to quality standards. …
Good Manufacturing Practices (GMP) for Metered-Dose Inhalers (MDI) – Detailed Guidelines Introduction Metered-Dose Inhalers: In the pharmaceutical industry, manufacturing practices are of utmost importance to ensure the safety, efficacy, and quality of the products produced. One such product is the Metered-Dose Inhaler (MDI), which is used for delivering a specific amount of medication to the …