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Definition of Microcapsules Microcapsules are small, spherical particles that consist of a core material (typically an active ingredient like a drug, nutrient, or bioactive compound) surrounded by a protective shell or coating. The core material can be liquid, solid, or gas, and the shell is typically made from biocompatible materials, such as polymers, lipids, or … Read more
Definition of Microspheres Microspheres are small, spherical particles typically ranging from 1 to 1000 microns in size. They are commonly used in drug delivery systems, diagnostics, and other pharmaceutical and biomedical applications. Microspheres are made from various materials, including polymers, lipids, and ceramics. These particles can encapsulate active ingredients such as drugs, enzymes, or other … Read more
Microencapsulation is a process where active substances (such as drugs, nutrients, or bioactive compounds) are enclosed within a protective coating or shell, typically in the micron or sub-micron size range (1 to 1000 microns). The primary goal is to protect the active ingredient from environmental factors (e.g., light, moisture, air) or to control the release … Read more
1. Introduction A drug distribution system in a hospital is the organized process by which medications are procured, stored, prepared, and delivered to patients with the primary aim of ensuring rational, safe, and timely drug therapy. This system plays a central role in the hospital’s therapeutic and administrative activities. The hospital pharmacy serves as the … Read more
ISO 14000: Environmental Management Systems Overview of ISO 14000 The ISO 14000 series is a set of international standards and guidelines developed by the International Organization for Standardization (ISO), specifically focused on environmental management systems (EMS). These standards provide a structured framework for organizations to systematically manage and improve their environmental performance. The primary aim … Read more
ISO 9000 is a series of internationally recognized standards that have been developed and published by the International Organization for Standardization (ISO) to guide organizations in establishing and maintaining effective quality management systems (QMS). These standards are based on universally accepted principles of quality assurance and management. The ISO 9000 family aims to help organizations … Read more
Definition Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. According to the ICH Q8 guideline: “QbD is a systematic approach to development that begins with predefined objectives and emphasizes product … Read more
Introduction Stability testing forms the backbone of pharmaceutical product development, ensuring that drug substances and drug products maintain their intended physical, chemical, biological, and microbiological properties throughout the proposed shelf life. The primary objective of stability testing is to furnish evidence on how the quality of a drug substance or product varies with time under … Read more
1. Introduction to ICH and QSEM The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) plays an indispensable role in the global pharmaceutical landscape. Formed in 1990, the ICH emerged from the necessity to bring regulatory authorities and pharmaceutical industry stakeholders together to harmonize the scientific and technical aspects of … Read more
1. Introduction The pharmaceutical industry is one of the most regulated industries worldwide. Medicines and medical products must be safe, effective, and of high quality before reaching the public. To achieve these goals across diverse regions and regulatory frameworks, a unified approach to drug development and approval is essential. Historically, drug manufacturers had to fulfill … Read more
