Regulatory Pharma Blogs
Good Manufacturing Practices (GMP) for Topical Products (External Preparations) Introduction Topical products, including creams, ointments, pastes, emulsions, lotions, solutions, dusting powders, and other similar products, play an essential role in the pharmaceutical industry, being directly applied to the skin for therapeutic, cosmetic, or protective purposes. As with all pharmaceutical products, ensuring the quality and safety …
Good Manufacturing Practices (GMP) for Oral Liquids (Syrups, Elixirs, Emulsions, and Suspensions) Oral Liquids: The manufacture of oral liquid pharmaceuticals, such as syrups, elixirs, emulsions, and suspensions, requires adherence to stringent guidelines to ensure product quality, safety, and consistency. One of the core standards for ensuring the integrity of pharmaceutical products is Good Manufacturing Practices …
Good Laboratory Practices (GLP) and Requirements of Premises and Equipment Good Laboratory Practices: The Drugs and Cosmetics Act in India outlines specific guidelines under Schedule L-1 to ensure that laboratories involved in testing, calibration, validation, and related activities maintain compliance with Good Laboratory Practices (GLP). These guidelines encompass the organization, maintenance of laboratory premises, equipment, …
Good Laboratory Practice (GLP) in Pharmaceuticals Introduction to Good Laboratory Practice (GLP) Good Laboratory Practice (GLP) is a comprehensive quality system that outlines the organizational processes, procedures, and conditions under which laboratory studies are planned, executed, monitored, recorded, reported, and archived. It is a set of principles intended to ensure the reliability, consistency, and reproducibility …
EU GMP Guidelines on Complaints, Quality Defects, and Product Recalls: Ensuring Pharmaceutical Safety and Compliance Pharmaceutical Safety and Compliance: In the pharmaceutical industry, ensuring the safety, quality, and efficacy of medicinal products is of paramount importance. To achieve this, regulatory frameworks, such as the European Union’s Good Manufacturing Practice (EU GMP) guidelines, provide stringent standards …
EU GMP Guidelines for the Preparation of a Site Master File for Pharmaceutical Manufacturers Site Master File: The Site Master File (SMF) is an essential component in the Good Manufacturing Practice (GMP) regulations, playing a crucial role in ensuring the quality and safety of medicinal products. Pharmaceutical manufacturers in the European Union (EU) must adhere …
EU GMP Guidelines for Medicinal Product Production: An Overview Medicinal Product Production: The European Union Good Manufacturing Practices (EU GMP) for medicinal products, both for human and veterinary use, are a critical set of standards designed to ensure the production of safe and effective pharmaceutical products. These guidelines outline the required processes for production, quality …
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 …